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JUNE 2021 - APPROVED PRODUCT LIST B - 1 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** 3 ** 3D IMAGING DRUG * 3D IMAGING AND DEVELOPMENT LLC N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 FLUORIDE F-18, F-18 3M * 3M CO PERIDEX, GLUCONATE * 3M HEALTH CARE INC AVAGARD, (OTC) DURAPREP, IODINE POVACRYLEX (OTC) 3M HEALTH CARE * 3M HEALTH CARE PREVENTION DIV SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC)

** 6 ** 60 DEGREES PHARMS * 60 DEGREES PHARMACEUTICALS LLC ARAKODA, SUCCINATE

** A ** AAA USA INC * ADVANCED ACCELERATOR APPLICATIONS USA INC LUTATHERA, LUTETIUM DOTATATE LU-177 NETSPOT, GALLIUM DOTATATE GA-68 AAIPHARMA LLC * AAIPHARMA LLC AZASAN, ABBVIE * ABBVIE INC ANDROGEL, CYCLOSPORINE, CYCLOSPORINE DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM GENGRAF, CYCLOSPORINE K-TAB, KALETRA, LOPINAVIR NIASPAN, NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NORVIR, SYNTHROID, SODIUM ** TARKA, TRANDOLAPRIL TRICOR, FENOFIBRATE TRILIPIX, FENOFIBRATE ULTANE, ZEMPLAR, PARICALCITOL ABBVIE ENDOCRINE * ABBVIE ENDOCRINE INC LUPANETA PACK, LEUPROLIDE ABBVIE ENDOCRINE INC * ABBVIE ENDOCRINE INC LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT, LEUPROLIDE ACETATE ABBVIE INC * ABBVIE INC DUOPA, MAVYRET, GLECAPREVIR NORVIR, RITONAVIR ORIAHNN (COPACKAGED), SODIUM,,NORETHINDRONE ACETATE ORILISSA, ELAGOLIX SODIUM RINVOQ, VENCLEXTA, VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 2 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** ABHAI INC * ABHAI INC DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE ABHAI LLC * ABHAI LLC , ATOVAQUONE , ACETAMINOPHEN AND , ACETAMINOPHEN ACETATE, DESMOPRESSIN ACETATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND METHYLBROMIDE, HOMATROPINE METHYLBROMIDE LEFLUNOMIDE, LEFLUNOMIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE CHLORIDE, OXYBUTYNIN CHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE URSODIOL, URSODIOL ABON PHARMS LLC * ABON PHARMACEUTICALS LLC , CLOFARABINE ABRAXIS BIOSCIENCE * ABRAXIS BIOSCIENCE LLC ABRAXANE, ABRAXIS PHARM * ABRAXIS PHARMACEUTICAL PRODUCTS IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE ACACIA * ACACIA PHARMA LTD BARHEMSYS, BYFAVO, BESYLATE ACADIA PHARMS INC * ACADIA PHARMACEUTICALS INC NUPLAZID, PIMAVANSERIN ACCELRX LABS * ACCELRX LABS LLC , CARISOPRODOL ACCORD HLTHCARE * ACCORD HEALTHCARE INC , ACETAZOLAMIDE , ALLOPURINOL HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE BESYLATE, AMLODIPINE BESYLATE , ANASTROZOLE , APIXABAN IN , ARGATROBAN , ARIPIPRAZOLE , ATORVASTATIN CALCIUM SULFATE, ATROPINE SULFATE , AZACITIDINE , BICALUTAMIDE , BIVALIRUDIN HYDROCHLORIDE, BUPROPION HYDROCHLORIDE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE , CAPECITABINE CARBIDOPA AND LEVODOPA, CARBIDOPA , CARBOPLATIN CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE , CISPLATIN CLOFARABINE, CLOFARABINE , CLONAZEPAM BISULFATE, CLOPIDOGREL BISULFATE , CLOZAPINE DALFAMPRIDINE, DALFAMPRIDINE DAPTOMYCIN, DAPTOMYCIN , DECITABINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 3 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ACCORD HEALTHCARE INC DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE , DOCETAXEL , DOFETILIDE MESYLATE, DOXAZOSIN MESYLATE ENTECAVIR, ENTECAVIR , EPLERENONE , EPTIFIBATIDE , ESCITALOPRAM OXALATE SODIUM, ESOMEPRAZOLE SODIUM , ETOPOSIDE EZETIMIBE, EZETIMIBE , FINASTERIDE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE , FLUOROURACIL DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE , FULVESTRANT , FUROSEMIDE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE , GLIMEPIRIDE , GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE , HYDROCHLOROTHIAZIDE SULFATE, HYDROXYCHLOROQUINE SULFATE IBANDRONATE SODIUM, IBANDRONATE SODIUM HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE , ITRACONAZOLE , LETROZOLE , LEVETIRACETAM LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ** LISINOPRIL, LISINOPRIL HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM , METHYLDOPA METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MITOMYCIN, MITOMYCIN SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL MYCOPHENOLIC , HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE , OXALIPLATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PACLITAXEL, PACLITAXEL HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PARICALCITOL, PARICALCITOL PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE , PRASUGREL HYDROCHLORIDE SODIUM, PRAVASTATIN SODIUM FUMARATE, QUETIAPINE FUMARATE RAMIPRIL, RAMIPRIL , RANOLAZINE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE CALCIUM, ROSUVASTATIN CALCIUM HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE , SIMVASTATIN , SPIRONOLACTONE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE , TACROLIMUS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 4 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ACCORD HEALTHCARE INC , TADALAFIL , TEMOZOLOMIDE , TEMSIROLIMUS TERIFLUNOMIDE, TERIFLUNOMIDE , TOPIRAMATE HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE , VIGABATRIN HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID ACCORD HLTHCARE INC * ACCORD HEALTHCARE INC USA , BUSULFAN , TIGECYCLINE ACELLA * ACELLA PHARMACEUTICALS LLC MALEATE, HYDROCHLORIDE AND , CICLOPIROX HYCLATE, DOXYCYCLINE HYCLATE , DUTASTERIDE , NIFEDIPINE SODIUM, PHENYTOIN SODIUM ACELLA PHARMS LLC * ACELLA PHARMACEUTICALS LLC , GABAPENTIN ACELRX PHARMS * ACELRX PHARMACEUTICALS INC DSUVIA, CITRATE ACERUS * ACERUS PHARMACEUTICALS CORP NATESTO, TESTOSTERONE ACI HEALTHCARE LTD * ACI HEALTHCARE LTD DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE GABAPENTIN, GABAPENTIN LEVETIRACETAM, LEVETIRACETAM SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE ACIC PHARMS * ACIC PHARMACEUTICALS INC TRANEXAMIC ACID, TRANEXAMIC ACID ACORDA * INC AMPYRA, DALFAMPRIDINE INBRIJA, LEVODOPA ACROTECH * ACROTECH BIOPHARMA LLC BELEODAQ, EVOMELA, HYDROCHLORIDE FOLOTYN, FUSILEV, LEVOLEUCOVORIN CALCIUM KHAPZORY, LEVOLEUCOVORIN MARQIBO KIT, SULFATE ACRUX DDS * ACRUX DDS PTY LTD , EFINACONAZOLE ACS DOBFAR * ACS DOBFAR SPA AND SULBACTAM, AMPICILLIN SODIUM CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFOXITIN, CEFOXITIN SODIUM CEFTAZIDIME, CEFTAZIDIME

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 5 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ACS DOBFAR SPA CEFTRIAXONE, CEFTRIAXONE SODIUM AND , CILASTATIN SODIUM MEROPENEM, MEROPENEM ACS DOBFAR SPA * ACS DOBFAR SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM SODIUM, CEFUROXIME SODIUM ERTAPENEM SODIUM, ERTAPENEM SODIUM MEROPENEM, MEROPENEM G POTASSIUM, PENICILLIN G POTASSIUM ELIZABETH * ACTAVIS ELIZABETH LLC , ALBENDAZOLE , ALPRAZOLAM HYDROCHLORIDE AND HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CLONAZEPAM, CLONAZEPAM HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE , DEFERASIROX DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, SULFATE, DEXTROAMPHETAMINE SULFATE DEXTROMETHORPHAN HYDROBROMIDE AND SULFATE, DEXTROMETHORPHAN HYDROBROMIDE SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE MALEATE, FLUVOXAMINE MALEATE GABAPENTIN, GABAPENTIN GLYBURIDE AND HYDROCHLORIDE, GLYBURIDE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE , INDAPAMIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE , LAMOTRIGINE , LOVASTATIN METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE SUCCINATE, METOPROLOL SUCCINATE NIFEDIPINE, NIFEDIPINE , OXAZEPAM OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE , PREGABALIN HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL RANOLAZINE, RANOLAZINE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE , TEMAZEPAM TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TARTRATE, ZOLPIDEM TARTRATE * ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF USA INC ALPRAZOLAM, ALPRAZOLAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE SULFATE, MORPHINE SULFATE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS INC * ACTAVIS INC DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE , METHOXSALEN ACTAVIS LABS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 6 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ACTAVIS LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC , PERMETHRIN ACTAVIS LABS FL * ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC) GUAIFENESIN, GUAIFENESIN (OTC) , ISOTRETINOIN MESALAMINE, MESALAMINE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE ACTAVIS LABS FL INC * ACTAVIS LABORATORIES FL INC , BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARTIA XT, DILTIAZEM HYDROCHLORIDE , CLARITHROMYCIN HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DALFAMPRIDINE, DALFAMPRIDINE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DICLOFENAC SODIUM AND , DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE , ENZALUTAMIDE HYDROCODONE BITARTRATE AND , HYDROCODONE BITARTRATE LEVETIRACETAM, LEVETIRACETAM , METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE SODIUM, NAPROXEN SODIUM , NITROFURANTOIN, MACROCRYSTALLINE , OMEPRAZOLE , PALIPERIDONE MESYLATE, PAROXETINE MESYLATE , POTASSIUM CHLORIDE , RAMELTEON CITRATE, TAMOXIFEN CITRATE TAZTIA XT, DILTIAZEM HYDROCHLORIDE TETRABENAZINE, TETRABENAZINE TRANEXAMIC ACID, TRANEXAMIC ACID , TROSPIUM CHLORIDE VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ACTAVIS LABS UT INC * ACTAVIS LABORATORIES UT INC , AZELAIC ACID BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CLINDAMYCIN PHOSPHATE AND , BENZOYL PEROXIDE CLONIDINE, CLONIDINE FIORICET W/ , ACETAMINOPHEN , LIDOCAINE , PROGESTERONE TESTOSTERONE, TESTOSTERONE * ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC , PIMECROLIMUS TESTOSTERONE, TESTOSTERONE ACTAVIS LLC * ACTAVIS LLC AZACITIDINE, AZACITIDINE , DAPSONE PHOSPHATE, FLUDARABINE PHOSPHATE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 7 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ACTAVIS LLC AN INDIRECT WHOLLY-OWNED SUB OF TEVA PHARMACEUTICALS USA INC DOCETAXEL, DOCETAXEL , HYDROXOCOBALAMIN OXALIPLATIN, OXALIPLATIN ACTAVIS MID ATLANTIC * ACTAVIS MID ATLANTIC LLC ACYCLOVIR, ACYCLOVIR AND BENZOYL PEROXIDE, ADAPALENE ADAPALENE, ADAPALENE DIPROPIONATE, BETAMETHASONE DIPROPIONATE , BETAMETHASONE VALERATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE AND , CLINDAMYCIN PHOSPHATE PROPIONATE, AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE , DESOXIMETASONE DICLOFENAC SODIUM, DICLOFENAC SODIUM , GRISEOFULVIN, MICROSIZE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE BUTYRATE, HYDROCORTISONE, HYDROCORTISONE LEVETIRACETAM, LEVETIRACETAM MESALAMINE, MESALAMINE NITROFURANTOIN, NITROFURANTOIN , NYSTATIN HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE VALNAC, BETAMETHASONE VALERATE * ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC IBUPROFEN, IBUPROFEN PERMETHRIN, PERMETHRIN (OTC) ACTAVIS PHARMA * ACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC NITRATE, MICONAZOLE NITRATE ACTAVIS TOTOWA * ACTAVIS TOTOWA LLC HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN PACLITAXEL, PACLITAXEL SODIUM, PANTOPRAZOLE SODIUM TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TARTRATE, VINORELBINE TARTRATE * ACTELION PHARMACEUTICALS US INC OPSUMIT, TRACLEER, UPTRAVI, VELETRI, EPOPROSTENOL SODIUM VENTAVIS, ZAVESCA, ACTIENT PHARMS * ACTIENT PHARMACEUTICALS LLC THEO-24, ADAMAS PHARMA * ADAMAS PHARMA LLC GOCOVRI, HYDROCHLORIDE OSMOLEX ER, AMANTADINE HYDROCHLORIDE ADAMIS PHARMS CORP * ADAMIS PHARMACEUTICALS CORP SYMJEPI, EPINEPHRINE ADAPTIS * ADAPTIS PHARMA PRIVATE LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 8 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ADAPTIS PHARMA PRIVATE LTD CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE MONTELUKAST SODIUM, MONTELUKAST SODIUM ADARE PHARMS INC * ADARE PHARMACEUTICALS INC DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE ADDMEDICA SAS * ADDMEDICA SAS SIKLOS, HYDROXYUREA ADHERA * ADHERA THERAPEUTICS INC PRESTALIA, AMLODIPINE BESYLATE ADIENNE SA * ADIENNE SA TEPADINA, AERIE PHARMS INC * AERIE PHARMACEUTICALS INC RHOPRESSA, NETARSUDIL MESYLATE ROCKLATAN, LATANOPROST AET PHARMA * AET PHARMA US INC LEFLUNOMIDE, LEFLUNOMIDE , POSACONAZOLE AGILE * AGILE THERAPEUTICS INC TWIRLA, ETHINYL ESTRADIOL AGNITIO * AGNITIO INC ETHACRYNIC ACID, ETHACRYNIC ACID , TRIAMTERENE AGOURON PHARMS * AGOURON PHARMACEUTICALS LLC VIRACEPT, MESYLATE AILEX PHARMS LLC * AILEX PHARMACEUTICALS LLC SUBSALICYLATE, AND HYDROCHLORIDE, BISMUTH CROMOLYN SODIUM, CROMOLYN SODIUM SODIUM PHENYLACETATE AND , SODIUM BENZOATE AIRIS PHARMA PVT LTD * AIRIS PHARMA PRIVATE LTD AMINOCAPROIC ACID, AMINOCAPROIC ACID AIZANT * AIZANT DRUG RESEARCH PRIVATE LTD ALBUTEROL SULFATE, ALBUTEROL SULFATE , ZILEUTON LTD * AJANTA PHARMA LTD MALATE, ALMOTRIPTAN MALATE AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE , CAPTOPRIL CHLORTHALIDONE, CHLORTHALIDONE CHOLESTYRAMINE, CHOLESTYRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE , DROXIDOPA DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE , ENTACAPONE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 9 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AJANTA PHARMA LTD FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE LAMOTRIGINE, LAMOTRIGINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE RANOLAZINE, RANOLAZINE , RISPERIDONE CITRATE, SILDENAFIL CITRATE , SILODOSIN TADALAFIL, TADALAFIL TOFACITINIB CITRATE, TOFACITINIB CITRATE TARTRATE, TOLTERODINE TARTRATE VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE , VORICONAZOLE , ZOLMITRIPTAN AKARX INC * AKARX INC DOPTELET, AVATROMBOPAG MALEATE AKCEA THERAPS * AKCEA THERAPEUTICS INC TEGSEDI, INOTERSEN SODIUM AKORN * AKORN OPERATING CO LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN , ACETYLCYSTEINE ACYCLOVIR, ACYCLOVIR , ADENOSINE AK-FLUOR 10%, FLUORESCEIN SODIUM AK-FLUOR 25%, FLUORESCEIN SODIUM AKBETA, HYDROCHLORIDE AKPENTOLATE, HYDROCHLORIDE AKTEN, LIDOCAINE HYDROCHLORIDE AKTOB, ALBUTEROL SULFATE, ALBUTEROL SULFATE ALFENTA, HYDROCHLORIDE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMICAR, AMINOCAPROIC ACID HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE ATROPINE SULFATE, ATROPINE SULFATE AZASITE, HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BACITRACIN AND B SULFATE, BACITRACIN ZINC BAL, BALANCED , BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE BETIMOL, BIMATOPROST, BIMATOPROST TARTRATE, BRIMONIDINE TARTRATE BROMFENAC SODIUM, BROMFENAC SODIUM CALCIPOTRIENE, CALCIPOTRIENE CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CEFTRIAXONE, CEFTRIAXONE SODIUM CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CICLOPIROX, CICLOPIROX HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 10 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AKORN OPERATING CO LLC CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE COGENTIN, BENZTROPINE MESYLATE CORMAX, CLOBETASOL PROPIONATE COSOPT PF, DORZOLAMIDE HYDROCHLORIDE COSOPT, DORZOLAMIDE HYDROCHLORIDE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE , DESONIDE DESOXIMETASONE, DESOXIMETASONE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIURIL, SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL , DRONABINOL EMBELINE E, CLOBETASOL PROPIONATE EMBELINE, CLOBETASOL PROPIONATE SULFATE, EPHEDRINE SULFATE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE EPTIFIBATIDE, EPTIFIBATIDE , ERYTHROMYCIN ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE , ETHOSUXIMIDE , FAMOTIDINE ACETONIDE, PROPIONATE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC) GABAPENTIN, GABAPENTIN , GATIFLOXACIN GENTAK, SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE , HALOPERIDOL LACTATE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN IC-GREEN, INDOCYANINE GREEN INAPSINE, IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE FUMARATE, KETOTIFEN FUMARATE (OTC) HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LACTULOSE, LACTULOSE LATANOPROST, LATANOPROST LEVETIRACETAM, LEVETIRACETAM LEVOCARNITINE, LEVOCARNITINE , LEVOFLOXACIN LIDOCAINE AND , LIDOCAINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) , LORAZEPAM ETABONATE, LOTEPREDNOL ETABONATE ACETATE, HYDROCHLORIDE, METHADONE HYDROCHLORIDE HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 11 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AKORN OPERATING CO LLC MORPHINE SULFATE, MORPHINE SULFATE HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE HYDROCHLORIDE AND MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC) SODIUM, NEDOCROMIL SODIUM NEMBUTAL SODIUM, SODIUM AND SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC NYSTATIN AND ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN , OFLOXACIN HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) CITRATE, ORPHENADRINE CITRATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE PARICALCITOL, PARICALCITOL HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE PYRAZINAMIDE, PYRAZINAMIDE RIFAMPIN, RIFAMPIN HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE , SODIUM NITROPRUSSIDE SUBLIMAZE PRESERVATIVE FREE, CITRATE SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE SODIUM, SULFACETAMIDE SODIUM AND , SULFAMETHOXAZOLE SULFATE, TERBUTALINE SULFATE TIMOLOL MALEATE, TIMOLOL MALEATE TIMOLOL, TIMOLOL TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOBRAMYCIN, TOBRAMYCIN TRANEXAMIC ACID, TRANEXAMIC ACID , TRIAMCINOLONE ACETONIDE TRIFLURIDINE, TRIFLURIDINE TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE TROPICACYL, HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE VOSOL HC, , GLACIAL VOSOL, ACETIC ACID, GLACIAL XOPENEX, LEVALBUTEROL HYDROCHLORIDE ZIOPTAN, TAFLUPROST ZOLEDRONIC ACID, ZOLEDRONIC ACID * ALCON LABORATORIES INC BSS PLUS, CALCIUM CHLORIDE BSS, CALCIUM CHLORIDE MIOSTAT, NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) ALCON LABS * ALCON LABORATORIES LTD HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE ALCON LABS INC * ALCON LABORATORIES INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 12 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALCON LABORATORIES INC ALCAINE, PROPARACAINE HYDROCHLORIDE CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE FLUORESCITE, FLUORESCEIN SODIUM ISOPTO ATROPINE, ATROPINE SULFATE MYDRIACYL, TROPICAMIDE PATADAY ONCE DAILY RELIEF, OLOPATADINE HYDROCHLORIDE (OTC) PATADAY TWICE DAILY RELIEF, OLOPATADINE HYDROCHLORIDE (OTC) ALCON PHARMS LTD * ALCON PHARMACEUTICALS LTD BETADINE, POVIDONE-IODINE ZADITOR, KETOTIFEN FUMARATE (OTC) ALEMBIC GLOBAL * ALEMBIC GLOBAL HOLDING SA , TREPROSTINIL ALEMBIC LABS * ALEMBIC LABS LLC BENZONATATE, BENZONATATE FUMARATE, BISOPROLOL FUMARATE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE ERGOCALCIFEROL, ERGOCALCIFEROL FENOFIBRATE, FENOFIBRATE GLYCOPYRROLATE, GLYCOPYRROLATE LEVETIRACETAM, LEVETIRACETAM METRONIDAZOLE, METRONIDAZOLE ALEMBIC LTD * ALEMBIC LTD CARBONATE, ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ALEMBIC PHARMS LTD * ALEMBIC PHARMACEUTICALS LTD ACETAZOLAMIDE, ACETAZOLAMIDE ACYCLOVIR, ACYCLOVIR AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND , AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE MALEATE, ASENAPINE MALEATE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BIMATOPROST, BIMATOPROST BOSENTAN, BOSENTAN BROMFENAC SODIUM, BROMFENAC SODIUM BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CILEXETIL, CANDESARTAN CILEXETIL CARBIDOPA AND LEVODOPA, CARBIDOPA , CELECOXIB CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE HYDROBROMIDE, DARIFENACIN HYDROBROMIDE DEFERASIROX, DEFERASIROX DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DESVENLAFAXINE, DESVENLAFAXINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE FAMOTIDINE, FAMOTIDINE , FEBUXOSTAT

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 13 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALEMBIC PHARMACEUTICALS LTD FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FENOFIBRIC ACID, CHOLINE FENOFIBRATE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN ITRACONAZOLE, ITRACONAZOLE LAMOTRIGINE, LAMOTRIGINE LEFLUNOMIDE, LEFLUNOMIDE , LINEZOLID LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE , MEPROBAMATE , METOLAZONE METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE, METRONIDAZOLE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE , MODAFINIL MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PREGABALIN, PREGABALIN RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SUCCINATE, SOLIFENACIN SUCCINATE TADALAFIL, TADALAFIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN TEMAZEPAM, TEMAZEPAM TERIFLUNOMIDE, TERIFLUNOMIDE THEOPHYLLINE, THEOPHYLLINE TIMOLOL MALEATE, TIMOLOL MALEATE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOBRAMYCIN, TOBRAMYCIN TRAVOPROST, TRAVOPROST VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN, VALSARTAN HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE ZOLMITRIPTAN, ZOLMITRIPTAN ALEOR DERMACEUTICALS * ALEOR DERMACEUTICALS LTD ADAPALENE, ADAPALENE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESONIDE, DESONIDE LIDOCAINE, LIDOCAINE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN , TAVABOROLE TESTOSTERONE, TESTOSTERONE ALEXZA PHARMS * ALEXZA PHARMACEUTICALS INC ADASUVE, ALFASIGMA * ALFASIGMA USA INC ZELNORM, TEGASEROD MALEATE ALIGNSCIENCE PHARMA * ALIGNSCIENCE PHARMA INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 14 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALIGNSCIENCE PHARMA INC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE INC * ALIMERA SCIENCES INC ILUVIEN, FLUOCINOLONE ACETONIDE ALK ABELLO * ALK-ABELLO INC OTIPRIO, CIPROFLOXACIN ALKALOIDA ZRT * ALKALOIDA CHEMICAL CO ZRT HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE ALKEM * LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE GABAPENTIN, GABAPENTIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ALKEM LABS LTD * ALKEM LABORATORIES LTD AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AMPHETAMINE SULFATE, AMPHETAMINE SULFATE ARIPIPRAZOLE, ARIPIPRAZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZATHIOPRINE, AZATHIOPRINE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CAPECITABINE, CAPECITABINE CEFDINIR, CEFDINIR CEFIXIME, CEFIXIME CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN HYDROCHLORIDE AND CLIDINIUM , CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORTHALIDONE, CHLORTHALIDONE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE , CLOBAZAM , COLCHICINE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE ETEXILATE MESYLATE, DABIGATRAN ETEXILATE MESYLATE DALFAMPRIDINE, DALFAMPRIDINE DEFERASIROX, DEFERASIROX DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE DROXIDOPA, DROXIDOPA DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESOMEPRAZOLE , ESOMEPRAZOLE MAGNESIUM EZETIMIBE AND SIMVASTATIN, EZETIMIBE EZETIMIBE, EZETIMIBE FINASTERIDE, FINASTERIDE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE GABAPENTIN, GABAPENTIN HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE LAMOTRIGINE, LAMOTRIGINE , LANSOPRAZOLE LIDOCAINE, LIDOCAINE LINEZOLID, LINEZOLID MARINOL, DRONABINOL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL , OLANZAPINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 15 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALKEM LABORATORIES LTD OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PREGABALIN, PREGABALIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE SODIUM, RABEPRAZOLE SODIUM RANOLAZINE, RANOLAZINE MESYLATE, RASAGILINE MESYLATE , RILUZOLE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM , RUFINAMIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE , SIROLIMUS SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TACROLIMUS, TACROLIMUS HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOBRAMYCIN, TOBRAMYCIN , TOLVAPTAN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE VALSARTAN, VALSARTAN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VIGABATRIN, VIGABATRIN * ALKERMES INC VIVITROL, NALTREXONE ALKERMES INC * ALKERMES INC ARISTADA INITIO KIT, ARISTADA, ARIPIPRAZOLE LAUROXIL LYBALVI, OLANZAPINE ALLEGIANCE HLTHCARE * ALLEGIANCE HEALTHCARE CORP POVIDONE IODINE, POVIDONE-IODINE (OTC) * ALLERGAN ACULAR LS, KETOROLAC TROMETHAMINE ALPHAGAN P, BRIMONIDINE TARTRATE BLEPH-10, SULFACETAMIDE SODIUM GENOPTIC, GENTAMICIN SULFATE ZYMAXID, GATIFLOXACIN * ALLERGAN INC ACULAR, KETOROLAC TROMETHAMINE ACUVAIL, KETOROLAC TROMETHAMINE ACZONE, DAPSONE ALOCRIL, NEDOCROMIL SODIUM ALPHAGAN P, BRIMONIDINE TARTRATE AVAGE, COMBIGAN, BRIMONIDINE TARTRATE ELESTAT, EPINASTINE HYDROCHLORIDE LASTACAFT, LATISSE, BIMATOPROST LUMIGAN, BIMATOPROST OCUFLOX, OFLOXACIN OZURDEX, POLYTRIM, POLYMYXIN B SULFATE RESTASIS MULTIDOSE, CYCLOSPORINE RESTASIS, CYCLOSPORINE TAZORAC, TAZAROTENE ZYMAR, GATIFLOXACIN * ALLERGAN PHARMACEUTICAL BETAGAN, LEVOBUNOLOL HYDROCHLORIDE BLEPHAMIDE S.O.P.,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 16 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALLERGAN PHARMACEUTICAL BLEPHAMIDE, PREDNISOLONE ACETATE FML FORTE, FML, FLUOROMETHOLONE PRED FORTE, PREDNISOLONE ACETATE PRED MILD, PREDNISOLONE ACETATE PRED-G, GENTAMICIN SULFATE * ALLERGAN SALES LLC ACTIGALL, URSODIOL ALORA, ESTRADIOL ANDRODERM, TESTOSTERONE AVYCAZ, AVIBACTAM SODIUM BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE BENTYL, DICYCLOMINE HYDROCHLORIDE BYSTOLIC, HYDROCHLORIDE CANASA, MESALAMINE CARAFATE, CELEXA, HYDROBROMIDE CONDYLOX, PODOFILOX CRINONE, PROGESTERONE DALVANCE, DALBAVANCIN HYDROCHLORIDE ESTRACE, ESTRADIOL FETZIMA, HYDROCHLORIDE FIORINAL W/CODEINE, FIORINAL, ASPIRIN GELNIQUE, OXYBUTYNIN CHLORIDE INFED, FERRIC OXYHYDROXIDE KADIAN, MORPHINE SULFATE LEXAPRO, ESCITALOPRAM OXALATE LINZESS, NAMENDA, MEMANTINE HYDROCHLORIDE NAMZARIC, DONEPEZIL HYDROCHLORIDE NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL OXYTROL FOR WOMEN, OXYBUTYNIN (OTC) OXYTROL, OXYBUTYNIN PYLERA, POTASSIUM RAPAFLO, SILODOSIN RECTIV, SAPHRIS, ASENAPINE MALEATE SAVELLA, HYDROCHLORIDE TEFLARO, CEFTAROLINE FOSAMIL UBRELVY, URSO 250, URSODIOL URSO FORTE, URSODIOL VIIBRYD, VILAZODONE HYDROCHLORIDE VRAYLAR, HYDROCHLORIDE ALLERGAN HOLDINGS * ALLERGAN HOLDINGS UNLTD CO VIBERZI, ALLERGAN INC * ALLERGAN INC DURYSTA, BIMATOPROST ALLERQUEST * ALLERQUEST LLC PRE-PEN, BENZYLPENICILLOYL POLYLYSINE ALLIED * ALLIED PHARMA INC CARISOPRODOL, CARISOPRODOL ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM ALMAJECT * ALMAJECT INC VORICONAZOLE, VORICONAZOLE ALMATICA * ALMATICA PHARMA INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 17 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALMATICA PHARMA INC GRALISE, GABAPENTIN * ALMATICA PHARMA LLC MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE NAPRELAN, NAPROXEN SODIUM TENORETIC 100, TENORETIC 50, ATENOLOL TENORMIN, ATENOLOL ZESTORETIC, HYDROCHLOROTHIAZIDE ZESTRIL, LISINOPRIL ALMIRALL * ALMIRALL LLC ACTICLATE, DOXYCYCLINE HYCLATE ACZONE, DAPSONE ALTABAX, AZELEX, AZELAIC ACID CORDRAN SP, FLURANDRENOLIDE CORDRAN, FLURANDRENOLIDE FLUOROPLEX, FLUOROURACIL KLISYRI, TIRBANIBULIN SEYSARA, HYDROCHLORIDE VELTIN, CLINDAMYCIN PHOSPHATE VERDESO, DESONIDE XOLEGEL, ALNYLAM PHARMS INC * INC GIVLAARI, SODIUM ONPATTRO, PATISIRAN SODIUM OXLUMO, SODIUM ALRA * ALRA LABORATORIES INC CHOLAC, LACTULOSE CONSTILAC, LACTULOSE GEN-XENE, DIPOTASSIUM IBU-TAB 200, IBUPROFEN (OTC) IBU-TAB, IBUPROFEN ALTAIRE PHARMS INC * ALTAIRE PHARMACEUTICALS INC ALTAFLUOR BENOX, BENOXINATE HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC) OFLOXACIN, OFLOXACIN ALTATHERA PHARMS LLC * ALTATHERA PHARMACEUTICALS LLC HYDROCHLORIDE, SOTALOL HYDROCHLORIDE ALTHERA PHARMS * ALTHERA PHARMACEUTICALS LLC ROSZET, EZETIMIBE ALVOGEN * ALVOGEN GROUP HOLDINGS 3 LLC FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FORFIVO XL, BUPROPION HYDROCHLORIDE * ALVOGEN GROUP HOLDINGS 4 LLC THYRO-TABS, LEVOTHYROXINE SODIUM ** * ALVOGEN INC ACETYLCYSTEINE, ACETYLCYSTEINE ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BONSITY, BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CARBIDOPA, CARBIDOPA CICLOPIROX, CICLOPIROX

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 18 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ALVOGEN INC CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DAPSONE, DAPSONE DEXAMETHASONE, DEXAMETHASONE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE , DISULFIRAM DYNACIN, MINOCYCLINE HYDROCHLORIDE ETHACRYNIC ACID, ETHACRYNIC ACID , EXEMESTANE , FELBAMATE , FLUOCINONIDE HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE LIDEX, FLUOCINONIDE LIDEX-E, FLUOCINONIDE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MELPHALAN, MELPHALAN METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE , NEVIRAPINE NITROGLYCERIN, NITROGLYCERIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RIVASTIGMINE, RIVASTIGMINE SPECTAZOLE, NITRATE * ALVOGEN MALTA OPERATIONS LTD PREGABALIN, PREGABALIN ALVOGEN PINE BROOK * ALVOGEN PINE BROOK LLC BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE ESTRADIOL, ESTRADIOL HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PREGABALIN, PREGABALIN AM REGENT * AMERICAN REGENT INC ACETYLCYSTEINE, ACETYLCYSTEINE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUSULFAN, BUSULFAN CAFFEINE CITRATE, CAFFEINE CITRATE CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CYANOCOBALAMIN, CYANOCOBALAMIN DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DROPERIDOL, DROPERIDOL , ESTRADIOL VALERATE , FOMEPIZOLE GLYCOPYRROLATE, GLYCOPYRROLATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INJECTAFER, FERRIC CARBOXYMALTOSE LEVOCARNITINE, LEVOCARNITINE , METHOCARBAMOL METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NITROGLYCERIN, NITROGLYCERIN OLANZAPINE, OLANZAPINE SELENIOUS ACID, SELENIOUS ACID , TESTOSTERONE CYPIONATE TRALEMENT, CUPRIC SULFATE TRANEXAMIC ACID, TRANEXAMIC ACID

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 19 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AMERICAN REGENT INC , VASOPRESSIN VENOFER, FERRIC OXYHYDROXIDE ZINC SULFATE, ZINC SULFATE AMARIN PHARMS * AMARIN PHARMACEUTICALS IRELAND LTD VASCEPA, ICOSAPENT ETHYL * AMGEN INC SENSIPAR, CINACALCET HYDROCHLORIDE AMGEN INC * AMGEN INC CORLANOR, IVABRADINE CORLANOR, IVABRADINE HYDROCHLORIDE LUMAKRAS, OTEZLA, AMICI * AMICI PHARMACEUTICALS LLC CATAFLAM, DICLOFENAC POTASSIUM AMICUS THERAPS US * AMICUS THERAPEUTICS US INC GALAFOLD, MIGALASTAT HYDROCHLORIDE AMIVAS * AMIVAS LLC , ARTESUNATE AMNEAL * AMNEAL EU LTD AMINOCAPROIC ACID, AMINOCAPROIC ACID APREMILAST, APREMILAST ATAZANAVIR SULFATE, ATAZANAVIR SULFATE BUSULFAN, BUSULFAN , CARMUSTINE CLOFARABINE, CLOFARABINE , CYCLOPHOSPHAMIDE DEFERASIROX, DEFERASIROX DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DIMETHYL FUMARATE, DIMETHYL FUMARATE DOCETAXEL, DOCETAXEL DOXERCALCIFEROL, DOXERCALCIFEROL DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE EPHEDRINE SULFATE, EPHEDRINE SULFATE , ETRAVIRINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FULVESTRANT, FULVESTRANT GLYCOPYRROLATE, GLYCOPYRROLATE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM ACETATE, METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METYROSINE, METYROSINE MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE BITARTRATE, NOREPINEPHRINE BITARTRATE OFLOXACIN, OFLOXACIN HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE * LLC ACTIVELLA, ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 20 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AMNEAL PHARMACEUTICALS LLC ACYCLOVIR, ACYCLOVIR AMINOCAPROIC ACID, AMINOCAPROIC ACID AZATHIOPRINE, AZATHIOPRINE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BUPRENORPHINE, BUPRENORPHINE CLOBAZAM, CLOBAZAM CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC) ELURYNG, ETHINYL ESTRADIOL ESTRADIOL, ESTRADIOL ETHINYL ESTRADIOL AND , ETHINYL ESTRADIOL FENOFIBRATE, FENOFIBRATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE LIDOCAINE, LIDOCAINE MESALAMINE, MESALAMINE NAPROXEN, NAPROXEN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RISPERIDONE, RISPERIDONE RITONAVIR, RITONAVIR SIROLIMUS, SIROLIMUS SUCRALFATE, SUCRALFATE TAVABOROLE, TAVABOROLE TESTOSTERONE, TESTOSTERONE TIGECYCLINE, TIGECYCLINE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE AMNEAL PHARM * AMNEAL PHARMACEUTICAL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE CHLORIDE, BETHANECHOL CHLORIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE ACETATE, FLECAINIDE ACETATE FOLIC ACID, FOLIC ACID GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE , PRIMIDONE AMNEAL PHARMS * AMNEAL PHARMACEUTICALS ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE ARIPIPRAZOLE, ARIPIPRAZOLE ATOVAQUONE, ATOVAQUONE CALCITRIOL, CALCITRIOL , CALCIUM ACETATE CAPECITABINE, CAPECITABINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE , CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE COLCHICINE, COLCHICINE DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC) DIVALPROEX SODIUM, DIVALPROEX SODIUM ENTECAVIR, ENTECAVIR ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESTRADIOL, ESTRADIOL FELBAMATE, FELBAMATE GABAPENTIN, GABAPENTIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 21 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AMNEAL PHARMACEUTICALS HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN INDOMETHACIN, INDOMETHACIN ITRACONAZOLE, ITRACONAZOLE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE, LIDOCAINE LINEZOLID, LINEZOLID LORAZEPAM, LORAZEPAM MEROPENEM, MEROPENEM METAXALONE, METAXALONE FUROATE, MOMETASONE FUROATE MONTELUKAST SODIUM, MONTELUKAST SODIUM NIACIN, NIACIN NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN , NIZATIDINE NORETHINDRONE ACETATE, NORETHINDRONE ACETATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE , OXCARBAZEPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE SULFATE, QUININE SULFATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SILDENAFIL CITRATE, SILDENAFIL CITRATE TELMISARTAN, TELMISARTAN TEMAZEPAM, TEMAZEPAM TEMOZOLOMIDE, TEMOZOLOMIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE SODIUM, WARFARIN SODIUM * AMNEAL PHARMACEUTICALS HOLDINGS GMBH DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE * AMNEAL PHARMACEUTICALS OF NEW YORK LLC , ABIRATERONE ACETATE ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE AMPHETAMINE SULFATE, AMPHETAMINE SULFATE ASPIRIN AND , ASPIRIN BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUDESONIDE, BUDESONIDE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CELECOXIB, CELECOXIB DUTASTERIDE, DUTASTERIDE ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC) GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN, IBUPROFEN (OTC) IRBESARTAN, IRBESARTAN LAMOTRIGINE, LAMOTRIGINE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 22 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AMNEAL PHARMACEUTICALS OF NEW YORK LLC NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OMEGA-3-ACID ETHYL , OMEGA-3-ACID ETHYL ESTERS OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PALIPERIDONE, PALIPERIDONE PARICALCITOL, PARICALCITOL PRASUGREL, PRASUGREL HYDROCHLORIDE RIVASTIGMINE, RIVASTIGMINE SILDENAFIL CITRATE, SILDENAFIL CITRATE SPIRONOLACTONE, SPIRONOLACTONE TOBRAMYCIN, TOBRAMYCIN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VALSARTAN, VALSARTAN VIGABATRIN, VIGABATRIN AMNEAL PHARMS CO * AMNEAL PHARMACEUTICALS CO GMBH ALBUTEROL SULFATE, ALBUTEROL SULFATE ARGATROBAN, ARGATROBAN BOSENTAN, BOSENTAN , BUMETANIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHLORTHALIDONE, CHLORTHALIDONE CLOBAZAM, CLOBAZAM CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ERYTHROMYCIN, ERYTHROMYCIN ETHACRYNIC ACID, ETHACRYNIC ACID ETODOLAC, ETODOLAC EZETIMIBE AND SIMVASTATIN, EZETIMIBE EZETIMIBE, EZETIMIBE FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE , NADOLOL NAPROXEN SODIUM AND HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE OXAPROZIN, OXAPROZIN PARICALCITOL, PARICALCITOL PHYTONADIONE, PHYTONADIONE PREGABALIN, PREGABALIN CARBONATE, SEVELAMER CARBONATE SILODOSIN, SILODOSIN SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TADALAFIL, TADALAFIL HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID URSODIOL, URSODIOL AMNEAL PHARMS NY * AMNEAL PHARMACEUTICALS NY LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ALPRAZOLAM, ALPRAZOLAM CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE IBUPROFEN, IBUPROFEN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 23 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AMNEAL PHARMACEUTICALS NY LLC IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE * AMNEAL PHARMACEUTICALS OF NY LLC , BEXAROTENE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN ISOTRETINOIN, ISOTRETINOIN OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PROGESTERONE, PROGESTERONE SILDENAFIL CITRATE, SILDENAFIL CITRATE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE AMPHASTAR PHARM * AMPHASTAR PHARMACEUTICAL INC (PRESERVATIVE FREE), ENOXAPARIN SODIUM AMPHASTAR PHARMS INC * AMPHASTAR PHARMACEUTICALS INC CORTROSYN, COSYNTROPIN ENOXAPARIN SODIUM, ENOXAPARIN SODIUM , GLUCAGON ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE ACETATE, MEDROXYPROGESTERONE ACETATE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE AMRING PHARMS * AMRING PHARMACEUTICALS INC TRIOXIDE, ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LATANOPROST, LATANOPROST LYSTEDA, TRANEXAMIC ACID MESALAMINE, MESALAMINE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE AMRYT * AMRYT PHARMACEUTICALS DAC JUXTAPID, LOMITAPIDE MESYLATE AMTA * AMTA LABS LTD DIVALPROEX SODIUM, DIVALPROEX SODIUM MYCOPHENOLIC ACID, MYCOPHENOLIC ACID POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE ANACOR PHARMS INC * ANACOR PHARMACEUTICALS INC EUCRISA, KERYDIN, TAVABOROLE ANBEX * ANBEX INC IOSAT, (OTC) ANBISON LAB * ANBISON LABORATORY CO LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM ANCHEN PHARMS * ANCHEN PHARMACEUTICALS INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 24 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ANCHEN PHARMACEUTICALS INC HEMIFUMARATE, ALISKIREN HEMIFUMARATE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE TRETINOIN, TRETINOIN ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * ANCHEN PHARMACEUTICALS, INC ALPRAZOLAM, ALPRAZOLAM CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN ANDA REPOSITORY * ANDA REPOSITORY LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE FLAC, FLUOCINOLONE ACETONIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN , ISONIAZID AND , LAMIVUDINE LEVETIRACETAM, LEVETIRACETAM METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PRASUGREL, PRASUGREL HYDROCHLORIDE PRIMIDONE, PRIMIDONE ANDOR PHARMS * ANDOR PHARMACEUTICALS LLC METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE ANDRX LABS LLC * ANDRX LABS LLC FORTAMET, METFORMIN HYDROCHLORIDE ANI PHARMS * ANI PHARMACEUTICALS INC AMINOCAPROIC ACID, AMINOCAPROIC ACID ARIMIDEX, ANASTROZOLE ATACAND HCT, CANDESARTAN CILEXETIL ATACAND, CANDESARTAN CILEXETIL BEXAROTENE, BEXAROTENE BRETHINE, TERBUTALINE SULFATE CARBIDOPA, CARBIDOPA CASODEX, BICALUTAMIDE CHOLESTYRAMINE, CHOLESTYRAMINE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CORTENEMA, HYDROCORTISONE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DIACETATE, DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE ETODOLAC, ETODOLAC EZETIMIBE AND SIMVASTATIN, EZETIMIBE FELBAMATE, FELBAMATE FENOFIBRATE (MICRONIZED), FENOFIBRATE FLECAINIDE ACETATE, FLECAINIDE ACETATE , FLUCONAZOLE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 25 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ANI PHARMACEUTICALS INC INDAPAMIDE, INDAPAMIDE INDERAL LA, PROPRANOLOL HYDROCHLORIDE INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE KIONEX, SODIUM POLYSTYRENE SULFONATE LITHOBID, LITHIUM CARBONATE LUVOX, FLUVOXAMINE MALEATE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MIGLUSTAT, MIGLUSTAT NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE , NILUTAMIDE OXISTAT, NITRATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PANDEL, HYDROCORTISONE PROBUTATE , PENICILLAMINE , PINDOLOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POTASSIUM CITRATE, POTASSIUM CITRATE HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE REGLAN, METOCLOPRAMIDE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TEMOZOLOMIDE, TEMOZOLOMIDE TRANEXAMIC ACID, TRANEXAMIC ACID VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VEREGEN, SINECATECHINS ANIMA * ANIMA PHARMACEUTICALS PVT LTD BETAMETHASONE VALERATE, BETAMETHASONE VALERATE DEXAMETHASONE, DEXAMETHASONE ANNORA * ANNORA PHARMA PRIVATE LTD DROXIDOPA, DROXIDOPA LAMIVUDINE, LAMIVUDINE ANNORA PHARMA * ANNORA PHARMA PRIVATE LTD BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE DEFERASIROX, DEFERASIROX ITRACONAZOLE, ITRACONAZOLE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MESALAMINE, MESALAMINE NABUMETONE, NABUMETONE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VIGABATRIN, VIGABATRIN , ZAFIRLUKAST ANTARES PHARMA INC * ANTARES PHARMA INC OTREXUP, METHOTREXATE SUCCINATE, SUMATRIPTAN SUCCINATE XYOSTED (AUTOINJECTOR), ANTIBIOTICE * ANTIBIOTICE SA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM SODIUM, NAFCILLIN SODIUM ANTRIM PHARMS LLC * ANTRIM PHARMACEUTICALS LLC ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ANXIN * ANXIN PHARMA INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 26 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ANXIN PHARMA INC SEVELAMER CARBONATE, SEVELAMER CARBONATE APELLIS PHARMS * APELLIS PHARMACEUTICALS INC EMPAVELI, PEGCETACOPLAN APGDI * ASTELLAS PHARMA GLOBAL DEVELOPMENT INC MYRBETRIQ GRANULES, MYRBETRIQ, MIRABEGRON APIL * ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD ACTONEL, RISEDRONATE SODIUM ASACOL HD, MESALAMINE ATELVIA, RISEDRONATE SODIUM DELZICOL, MESALAMINE ENABLEX, DARIFENACIN HYDROBROMIDE ESTROSTEP FE, ETHINYL ESTRADIOL FEMHRT, ETHINYL ESTRADIOL LO LOESTRIN FE, ETHINYL ESTRADIOL MINASTRIN 24 FE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL TAYTULLA, ETHINYL ESTRADIOL APNAR PHARMA LP * APNAR PHARMA LP BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE APOTEX * APOTEX INC ABIRATERONE ACETATE, ABIRATERONE ACETATE ACYCLOVIR, ACYCLOVIR ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATOVAQUONE, ATOVAQUONE AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE BESILATE, BEPOTASTINE BESILATE BUSULFAN, BUSULFAN CARBIDOPA AND LEVODOPA, CARBIDOPA CEFUROXIME AXETIL, CEFUROXIME AXETIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CIMETIDINE, CIMETIDINE (OTC) CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE ETODOLAC, ETODOLAC EZETIMIBE, EZETIMIBE FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FENOFIBRATE (MICRONIZED), FENOFIBRATE , FLUNISOLIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC) FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 27 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * APOTEX INC FULVESTRANT, FULVESTRANT , GEMFIBROZIL GLIPIZIDE, GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM ICOSAPENT ETHYL, ICOSAPENT ETHYL MESYLATE, IMATINIB MESYLATE LAMIVUDINE, LAMIVUDINE LEVETIRACETAM, LEVETIRACETAM DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE SODIUM, MICAFUNGIN SODIUM MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OMEPRAZOLE, OMEPRAZOLE OMEPRAZOLE, OMEPRAZOLE (OTC) ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLAMINE, PENICILLAMINE , PENTOXIFYLLINE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREGABALIN, PREGABALIN RAMIPRIL, RAMIPRIL HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SIROLIMUS, SIROLIMUS SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TETRABENAZINE, TETRABENAZINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TIGECYCLINE, TIGECYCLINE TIMOLOL MALEATE, TIMOLOL MALEATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID TRAVOPROST, TRAVOPROST TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID APOTEX CORP * APOTEX CORP QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE APOTEX INC * APOTEX INC HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM ARIPIPRAZOLE, ARIPIPRAZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BENZONATATE, BENZONATATE BICALUTAMIDE, BICALUTAMIDE BIMATOPROST, BIMATOPROST BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE -SALMON, CALCITONIN SALMON , CARBAMAZEPINE CARBIDOPA AND LEVODOPA, CARBIDOPA

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 28 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * APOTEX INC CEFPROZIL, CEFPROZIL CELECOXIB, CELECOXIB CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM IMIQUIMOD, IMIQUIMOD , IPRATROPIUM BROMIDE KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN MODAFINIL, MODAFINIL MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MOMETASONE FUROATE, MOMETASONE FUROATE MYCOPHENOLIC ACID, MYCOPHENOLIC ACID OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) RISEDRONATE SODIUM, RISEDRONATE SODIUM RISPERIDONE, RISPERIDONE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * APOTEX INC ETOBICOKE SITE ACYCLOVIR, ACYCLOVIR DISODIUM, BALSALAZIDE DISODIUM BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBAMAZEPINE, CARBAMAZEPINE , CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE ETODOLAC, ETODOLAC SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN LEFLUNOMIDE, LEFLUNOMIDE , LORATADINE (OTC) MELOXICAM, MELOXICAM , MIRTAZAPINE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE , ZONISAMIDE * APOTEX INC RICHMOND HILL AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BUDESONIDE, BUDESONIDE (OTC) DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE APOTEX TECHNOLOGIES * APOTEX TECHNOLOGIES INC PAXIL CR, PAROXETINE HYDROCHLORIDE PAXIL, PAROXETINE HYDROCHLORIDE APOTHECON * APOTHECON INC DIV KENALOG-10, TRIAMCINOLONE ACETONIDE KENALOG-40, TRIAMCINOLONE ACETONIDE KENALOG-80, TRIAMCINOLONE ACETONIDE APP PHARMS * APP PHARMACEUTICALS LLC DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE APPCO * APPCO PHARMA LLC ACETAZOLAMIDE, ACETAZOLAMIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 29 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * APPCO PHARMA LLC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MODAFINIL, MODAFINIL OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE RAMELTEON, RAMELTEON SILDENAFIL CITRATE, SILDENAFIL CITRATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLMITRIPTAN, ZOLMITRIPTAN APRECIA PHARMS * APRECIA PHARMACEUTICALS LLC SPRITAM, LEVETIRACETAM APTAPHARMA INC * APTAPHARMA INC IBUPROFEN, IBUPROFEN (OTC) SILDENAFIL CITRATE, SILDENAFIL CITRATE AQUESTIVE * AQUESTIVE THERAPEUTICS INC SYMPAZAN, CLOBAZAM ARBOR PHARMS LLC * ARBOR PHARMACEUTICALS LLC BIDIL, HYDRALAZINE HYDROCHLORIDE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EDARBI, AZILSARTAN KAMEDOXOMIL EDARBYCLOR, AZILSARTAN KAMEDOXOMIL ERY-TAB, ERYTHROMYCIN ERYPED, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN, ERYTHROMYCIN EVEKEO ODT, AMPHETAMINE SULFATE EVEKEO, AMPHETAMINE SULFATE GLIADEL, CARMUSTINE HORIZANT, NYMALIZE, SKLICE, (OTC) SOTYLIZE, SOTALOL HYDROCHLORIDE TRIPTODUR KIT, PAMOATE ARCO PHARMS LLC * ARCO PHARMACEUTICALS LLC THYROSHIELD, POTASSIUM IODIDE (OTC) AREVA PHARMS * AREVA PHARMACEUTICALS INC FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FUROSEMIDE, FUROSEMIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE ARISE * ARISE PHARMACEUTICALS LLC IBUPROFEN, IBUPROFEN (OTC) LAMIVUDINE, LAMIVUDINE ARMSTRONG PHARMS * ARMSTRONG PHARMACEUTICALS INC PRIMATENE MIST, EPINEPHRINE (OTC) ARRAY BIOPHARMA INC * ARRAY BIOPHARMA INC BRAFTOVI, MEKTOVI, ASCEND THERAPS US * ASCEND THERAPEUTICS US LLC BINOSTO, ALENDRONATE SODIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 30 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ASCEND THERAPEUTICS US LLC ESTROGEL, ESTRADIOL ASCENT PHARMS INC * ASCENT PHARMACEUTICALS INC BENZONATATE, BENZONATATE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DRONABINOL, DRONABINOL DUTASTERIDE, DUTASTERIDE GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IBUPROFEN, IBUPROFEN (OTC) METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ASPEN * ASPEN PHARMA USA INC HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE ASPEN GLOBAL * ASPEN GLOBAL INC MYLERAN, BUSULFAN ASPEN GLOBAL INC * ASPEN GLOBAL INC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CYCLESSA, HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE LEUKERAN, THIOGUANINE, THIOGUANINE ASPIRO * ASPIRO PHARMA LTD SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE ASSERTIO * INC CAMBIA, DICLOFENAC POTASSIUM ZIPSOR, DICLOFENAC POTASSIUM ASTELLAS * ASTELLAS PHARMA US INC AMBISOME, ASTAGRAF XL, TACROLIMUS CRESEMBA, SULFATE LEXISCAN, MYCAMINE, MICAFUNGIN SODIUM PROGRAF, TACROLIMUS VESICARE LS, SOLIFENACIN SUCCINATE VESICARE, SOLIFENACIN SUCCINATE XOSPATA, FUMARATE XTANDI, ENZALUTAMIDE ASTRAL * ASTRAL STERITECH PVT LTD AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM ASTRAZENECA * ASTRAZENECA LP PULMICORT FLEXHALER, BUDESONIDE SYMBICORT, BUDESONIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 31 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ASTRAZENECA PHARMACEUTICALS LP BEVESPI AEROSPHERE, FUMARATE BRILINTA, DALIRESP, DUAKLIR PRESSAIR, FASLODEX, FULVESTRANT IRESSA, KOSELUGO, SULFATE LOKELMA, SODIUM CYCLOSILICATE LYNPARZA, NEXIUM IV, ESOMEPRAZOLE SODIUM NEXIUM, ESOMEPRAZOLE MAGNESIUM PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC) PULMICORT RESPULES, BUDESONIDE SEROQUEL, QUETIAPINE FUMARATE TAGRISSO, MESYLATE TUDORZA PRESSAIR, ACLIDINIUM BROMIDE ZOMIG, ZOLMITRIPTAN ZOMIG-ZMT, ZOLMITRIPTAN * ASTRAZENECA UK LTD CALQUENCE, SEROQUEL XR, QUETIAPINE FUMARATE ASTRAZENECA AB * ASTRAZENECA AB BREZTRI AEROSPHERE, BUDESONIDE BYDUREON BCISE, BYETTA, EXENATIDE SYNTHETIC FARXIGA, DAPAGLIFLOZIN KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE QTERN, DAPAGLIFLOZIN SYMLIN, ACETATE XIGDUO XR, DAPAGLIFLOZIN ASTRAZENECA LP * ASTRAZENECA LP NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC) ATHEM * ATHEM HOLDINGS LLC CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) FOLIC ACID, FOLIC ACID TOLTERODINE TARTRATE, TOLTERODINE TARTRATE ATHENA * ATHENA BIOSCIENCES LLC FIBRICOR, FENOFIBRIC ACID QDOLO, TRAMADOL HYDROCHLORIDE ATHENEX * ATHENEX PHARMACEUTICAL DIV PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM ATHENEX INC * ATHENEX INC BUSULFAN, BUSULFAN DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FUROSEMIDE, FUROSEMIDE GLYCOPYRROLATE, GLYCOPYRROLATE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TERBUTALINE SULFATE, TERBUTALINE SULFATE SODIUM, VALPROATE SODIUM ATLANTIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 32 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * ATLANTIDE PHARMACEUTICALS AG ENTACAPONE, ENTACAPONE LAMOTRIGINE, LAMOTRIGINE LISINOPRIL, LISINOPRIL PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ATLAS PHARMS LLC * ATLAS PHARMACEUTICALS LLC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ATNAHS PHARMA US * ATNAHS PHARMA US LTD ANAPROX DS, NAPROXEN SODIUM EC-NAPROSYN, NAPROXEN NAPROSYN, NAPROXEN ATON * ATON PHARMA INC LODOSYN, CARBIDOPA AUCTA * AUCTA PHARMACEUTICALS INC DEFERASIROX, DEFERASIROX VIGADRONE, VIGABATRIN AURINIA * AURINIA PHARMACEUTICALS INC LUPKYNIS, VOCLOSPORIN AUROBINDO * LTD , AMOXICILLIN CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLARITHROMYCIN, CLARITHROMYCIN DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE NEVIRAPINE, NEVIRAPINE ZIDOVUDINE, ZIDOVUDINE AUROBINDO PHARMA * AUROBINDO PHARMA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM * AUROBINDO PHARMA LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMPICILLIN SODIUM, AMPICILLIN SODIUM ATENOLOL, ATENOLOL BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CARISOPRODOL, CARISOPRODOL , CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 33 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AUROBINDO PHARMA LTD LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MELOXICAM, MELOXICAM METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE RIBAVIRIN, RIBAVIRIN SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRANDOLAPRIL, TRANDOLAPRIL VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE , ZALEPLON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE AUROBINDO PHARMA LTD * AUROBINDO PHARMA LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM HYDROBROMIDE, GALANTAMINE HYDROBROMIDE LEVOFLOXACIN, LEVOFLOXACIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE * AUROBINDO PHARMA LTD SULFATE AND LAMIVUDINE, ABACAVIR SULFATE ABACAVIR SULFATE, ABACAVIR SULFATE ACETAMINOPHEN, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE AFIRMELLE, ETHINYL ESTRADIOL ALBUTEROL SULFATE, ALBUTEROL SULFATE ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN ARIPIPRAZOLE, ARIPIPRAZOLE , ARMODAFINIL ATAZANAVIR SULFATE, ATAZANAVIR SULFATE ATHENTIA NEXT, LEVONORGESTREL (OTC) ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AUROVELA 1.5/30, ETHINYL ESTRADIOL AUROVELA 1/20, ETHINYL ESTRADIOL AUROVELA 24 FE, ETHINYL ESTRADIOL AUROVELA FE 1.5/30, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 34 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AUROBINDO PHARMA LTD AUROVELA FE 1/20, ETHINYL ESTRADIOL AYUNA, ETHINYL ESTRADIOL AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BIVALIRUDIN, BIVALIRUDIN HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CARBIDOPA, CARBIDOPA CEFIXIME, CEFIXIME CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CELECOXIB, CELECOXIB CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC) CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE , CHLORZOXAZONE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CLOZAPINE, CLOZAPINE CYANOCOBALAMIN, CYANOCOBALAMIN CYONANZ, ETHINYL ESTRADIOL DALFAMPRIDINE, DALFAMPRIDINE DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOFETILDE, DOFETILIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DROXIDOPA, DROXIDOPA DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE DUTASTERIDE, DUTASTERIDE , EFAVIRENZ EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ EFINACONAZOLE, EFINACONAZOLE ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ENTACAPONE, ENTACAPONE ENTECAVIR, ENTECAVIR EPHEDRINE SULFATE, EPHEDRINE SULFATE EPTIFIBATIDE, EPTIFIBATIDE ERTAPENEM SODIUM, ERTAPENEM SODIUM ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM , ESZOPICLONE , ETOMIDATE EZETIMIBE, EZETIMIBE FAMCICLOVIR, FAMCICLOVIR FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) , FELODIPINE FENOFIBRATE, FENOFIBRATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 35 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AUROBINDO PHARMA LTD FENOFIBRIC ACID, CHOLINE FENOFIBRATE FUMARATE, FESOTERODINE FUMARATE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE FINASTERIDE, FINASTERIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCONAZOLE, FLUCONAZOLE , FLUCYTOSINE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE SODIUM, FONDAPARINUX SODIUM FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FUROSEMIDE, FUROSEMIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE, GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC) GUAIFENESIN, GUAIFENESIN (OTC) IBANDRONATE SODIUM, IBANDRONATE SODIUM IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) ICLEVIA, ETHINYL ESTRADIOL INCASSIA, NORETHINDRONE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE ISOSULFAN BLUE, ISOSULFAN BLUE KALLIGA, DESOGESTREL LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LEFLUNOMIDE, LEFLUNOMIDE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LINEZOLID, LINEZOLID LO SIMPESSE, ETHINYL ESTRADIOL LO-ZUMANDIMINE, LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MEROPENEM, MEROPENEM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHENAMINE HIPPURATE, METHENAMINE HIPPURATE METHOCARBAMOL, METHOCARBAMOL METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METRONIDAZOLE, METRONIDAZOLE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MILI, ETHINYL ESTRADIOL LACTATE IN DEXTROSE 5%, MILRINONE LACTATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MODAFINIL, MODAFINIL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 36 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AUROBINDO PHARMA LTD MONTELUKAST SODIUM, MONTELUKAST SODIUM MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NADOLOL, NADOLOL NAFCILLIN SODIUM, NAFCILLIN SODIUM NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN NEVIRAPINE, NEVIRAPINE NEXESTA FE, ETHINYL ESTRADIOL NIACIN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NYLIA 1/35, ETHINYL ESTRADIOL NYLIA 7/7/7, ETHINYL ESTRADIOL OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXACILLIN SODIUM, OXACILLIN SODIUM PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PARICALCITOL, PARICALCITOL PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PHENYTOIN SODIUM, PHENYTOIN SODIUM PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PRASUGREL, PRASUGREL HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RAMIPRIL, RAMIPRIL , REPAGLINIDE RISEDRONATE SODIUM, RISEDRONATE SODIUM RISPERIDONE, RISPERIDONE RITONAVIR, RITONAVIR RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE , ROCURONIUM BROMIDE ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SEVELAMER CARBONATE, SEVELAMER CARBONATE SILDENAFIL CITRATE, SILDENAFIL CITRATE SILODOSIN, SILODOSIN SIMLIYA, DESOGESTREL SIMPESSE, ETHINYL ESTRADIOL SPIRONOLACTONE, SPIRONOLACTONE SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TADALAFIL, TADALAFIL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 37 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AUROBINDO PHARMA LTD TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TIGECYCLINE, TIGECYCLINE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOBRAMYCIN, TOBRAMYCIN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID TRI-LO-MILI, ETHINYL ESTRADIOL TRI-MILI, ETHINYL ESTRADIOL VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN, VALSARTAN VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE , VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID ZOLMITRIPTAN, ZOLMITRIPTAN ZONISAMIDE, ZONISAMIDE ZUMANDIMINE, DROSPIRENONE * AUROBINDO PHARMA LTD INC ZIDOVUDINE, ZIDOVUDINE AUROLIFE PHARMA LLC * AUROLIFE PHARMA LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMPHETAMINE SULFATE, AMPHETAMINE SULFATE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC) FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE LORAZEPAM, LORAZEPAM METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC) OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE AUROMEDICS PHARMA * AUROMEDICS PHARMA LLC , DACTINOMYCIN HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE FULVESTRANT, FULVESTRANT HYDROCHLORIDE, KETAMINE HYDROCHLORIDE AUSTARPHARMA * AUSTARPHARMA LLC FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE AUSTARPHARMA LLC * AUSTARPHARMA LLC METHOCARBAMOL, METHOCARBAMOL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 38 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** AUXILIUM PHARMS INC * AUXILIUM PHARMACEUTICALS INC TESTOPEL, TESTOSTERONE THEO-24, THEOPHYLLINE AUXILIUM PHARMS LLC * AUXILIUM PHARMACEUTICALS LLC EDEX, ALPROSTADIL TESTIM, TESTOSTERONE THEO-24, THEOPHYLLINE AVACOR PRODS * AVACOR PRODUCTS LLC MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) AVANIR PHARMS * AVANIR PHARMACEUTICALS INC NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE AVANTHI INC * AVANTHI INC CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC) DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE INDOMETHACIN, INDOMETHACIN LOMAIRA, PHENTERMINE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE AVEMA PHARMA * AVEMA PHARMA SOLUTIONS IBUPROFEN, IBUPROFEN (OTC) AVENT * AVENT INC PYTEST KIT, , C-14 PYTEST, UREA, C-14 AVEO PHARMS * AVEO PHARMACEUTICALS INC FOTIVDA, HYDROCHLORIDE AVERITAS * AVERITAS PHARMA INC QUTENZA, AVET * AVET PHARMACEUTICALS INC ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL AVEVA * AVEVA SYSTEMS INC CLONIDINE, CLONIDINE FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-37, FENTANYL FENTANYL-50, FENTANYL FENTANYL-62, FENTANYL FENTANYL-75, FENTANYL FENTANYL-87, FENTANYL , NICOTINE (OTC) AVID RADIOPHARMS INC * AVID RADIOPHARMACEUTICALS INC AMYVID, F-18 TAUVID, FLORTAUCIPIR F-18 AVION PHARMS * AVION PHARMACEUTICALS LLC BALCOLTRA, ETHINYL ESTRADIOL GLOPERBA, COLCHICINE PONSTEL, AVONDALE PHARMS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 39 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A ** * AVONDALE PHARMACEUTICALS LLC NIACOR, NIACIN AXAR PHARMS INC * AXAR PHARMACEUTICALS INC TARTRATE, ARFORMOTEROL TARTRATE AYTU * AYTU BIOSCIENCE INC KARBINAL ER, MALEATE TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX ZOLPIMIST, ZOLPIDEM TARTRATE AZURITY * AZURITY PHARMACEUTICALS INC EPANED, MALEATE FIRVANQ KIT, VANCOMYCIN HYDROCHLORIDE KATERZIA, AMLODIPINE BENZOATE QBRELIS, LISINOPRIL XATMEP, METHOTREXATE SODIUM

** B ** B BRAUN * B BRAUN MEDICAL INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL AMINO , AMINO ACIDS BALANCED SALT, CALCIUM CHLORIDE CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE FREAMINE HBC 6.9%, AMINO ACIDS FREAMINE III 10%, AMINO ACIDS FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS FREAMINE III 8.5%, AMINO ACIDS 1.5% IN PLASTIC CONTAINER, GLYCINE SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPATAMINE 8%, AMINO ACIDS ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 40 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * B BRAUN MEDICAL INC ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE 10% IN PLASTIC CONTAINER, MANNITOL MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE NEPHRAMINE 5.4%, AMINO ACIDS NUTRILIPID 10%, NUTRILIPID 20%, SOYBEAN OIL PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 41 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * B BRAUN MEDICAL INC POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROCALAMINE, AMINO ACIDS RESECTISOL IN PLASTIC CONTAINER, MANNITOL RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE 3.3% IN PLASTIC CONTAINER, SORBITOL STERILE FOR IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE TROPHAMINE 10%, AMINO ACIDS TROPHAMINE, AMINO ACIDS B BRAUN MEDICAL INC * B BRAUN MEDICAL INC ACETAMINOPHEN, ACETAMINOPHEN BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE CLOROTEKAL, HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE, MAGNESIUM SULFATE MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM BAJAJ * BAJAJ MEDICAL CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE * BAJAJ MEDICAL LLC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC) BANNER SCIENCES * BANNER LIFE SCIENCES LLC BAFIERTAM, MONOMETHYL FUMARATE BARR * BARR LABORATORIES INC AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE ARANELLE, ETHINYL ESTRADIOL ASPIRIN AND DIPYRIDAMOLE, ASPIRIN BALZIVA-28, ETHINYL ESTRADIOL CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM , DANAZOL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIPYRIDAMOLE, DIPYRIDAMOLE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DUTASTERIDE, DUTASTERIDE ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL ESTRADIOL AND NORGESTIMATE, ESTRADIOL ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE ACETATE, FLUDROCORTISONE ACETATE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE HYDROXYUREA, HYDROXYUREA HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 42 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BARR LABORATORIES INC ISONIAZID, ISONIAZID JUNEL 1.5/30, ETHINYL ESTRADIOL JUNEL 1/20, ETHINYL ESTRADIOL JUNEL FE 1.5/30, ETHINYL ESTRADIOL JUNEL FE 1/20, ETHINYL ESTRADIOL KARIVA, DESOGESTREL KELNOR, ETHINYL ESTRADIOL LESSINA-28, ETHINYL ESTRADIOL MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE METHOTREXATE SODIUM, METHOTREXATE SODIUM NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NIACIN, NIACIN NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORTREL 0.5/35-28, ETHINYL ESTRADIOL NORTREL 1/35-21, ETHINYL ESTRADIOL NORTREL 1/35-28, ETHINYL ESTRADIOL NORTREL 7/7/7, ETHINYL ESTRADIOL PORTIA-28, ETHINYL ESTRADIOL SPRINTEC, ETHINYL ESTRADIOL TREXALL, METHOTREXATE SODIUM TRI-LEGEST 21, ETHINYL ESTRADIOL TRI-LEGEST FE, ETHINYL ESTRADIOL TRI-SPRINTEC, ETHINYL ESTRADIOL WARFARIN SODIUM, WARFARIN SODIUM * LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM BARR LABS INC * BARR LABORATORIES INC , ACITRETIN CLOZAPINE, CLOZAPINE ESTRADIOL, ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OLANZAPINE, OLANZAPINE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) TRETINOIN, TRETINOIN TRI LO SPRINTEC, ETHINYL ESTRADIOL BAUDAX * BAUDAX BIO INC ANJESO, MELOXICAM BAUSCH * AMERICAS INC ACANYA, BENZOYL PEROXIDE ARAZLO, TAZAROTENE BENZACLIN, BENZOYL PEROXIDE BRYHALI, HALOBETASOL PROPIONATE DUOBRII, HALOBETASOL PROPIONATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EFUDEX, FLUOROURACIL JUBLIA, EFINACONAZOLE LOCOID, HYDROCORTISONE BUTYRATE MEPHYTON, PHYTONADIONE ONEXTON, BENZOYL PEROXIDE OXSORALEN-ULTRA, METHOXSALEN SYPRINE, TRIENTINE HYDROCHLORIDE * BAUSCH HEALTH IRELAND LTD ERTACZO, NITRATE TARGRETIN, BEXAROTENE * BAUSCH HEALTH US LLC ALAWAY, KETOTIFEN FUMARATE (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 43 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAUSCH HEALTH US LLC ALDARA, IMIQUIMOD AMMONUL, SODIUM BENZOATE ANCOBON, FLUCYTOSINE APLENZIN, BUPROPION HYDROBROMIDE ATIVAN, LORAZEPAM CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM CARDIZEM CD, DILTIAZEM HYDROCHLORIDE CARDIZEM LA, DILTIAZEM HYDROCHLORIDE CARDIZEM, DILTIAZEM HYDROCHLORIDE CESAMET, CLINDAGEL, CLINDAMYCIN PHOSPHATE D.H.E. 45, MESYLATE DEMSER, METYROSINE DIASTAT ACUDIAL, DIASTAT, DIAZEPAM ELIDEL, PIMECROLIMUS GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE ISORDIL, ISUPREL, ISOPROTERENOL HYDROCHLORIDE KLARON, SULFACETAMIDE SODIUM LIBRAX, CHLORDIAZEPOXIDE HYDROCHLORIDE LOCOID, HYDROCORTISONE BUTYRATE LOPROX, CICLOPIROX LUZU, MESTINON, PYRIDOSTIGMINE BROMIDE METHAZOLAMIDE, METHAZOLAMIDE METROGEL-VAGINAL, METRONIDAZOLE MIGRANAL, DIHYDROERGOTAMINE MESYLATE MINOCIN, MINOCYCLINE HYDROCHLORIDE SOLODYN, MINOCYCLINE HYDROCHLORIDE TASMAR, TIAZAC, DILTIAZEM HYDROCHLORIDE VANOS, FLUOCINONIDE VASERETIC, ENALAPRIL MALEATE VASOTEC, ENALAPRIL MALEATE VIRAZOLE, RIBAVIRIN WELLBUTRIN XL, BUPROPION HYDROCHLORIDE XENAZINE, TETRABENAZINE XERESE, ACYCLOVIR ZELAPAR, SELEGILINE HYDROCHLORIDE ZIANA, CLINDAMYCIN PHOSPHATE ZOVIRAX, ACYCLOVIR ZYCLARA, IMIQUIMOD BAUSCH AND LOMB * BAUSCH AND LOMB INC ALAWAY, KETOTIFEN FUMARATE (OTC) ALREX, LOTEPREDNOL ETABONATE BESIVANCE, HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE SODIUM, FLURBIPROFEN SODIUM IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE ISTALOL, TIMOLOL MALEATE LATANOPROST, LATANOPROST LOTEMAX, LOTEPREDNOL ETABONATE MIOCHOL-E, CHLORIDE OFLOXACIN, OFLOXACIN OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC) PROLENSA, BROMFENAC SODIUM RETISERT, FLUOCINOLONE ACETONIDE SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE TIMOLOL MALEATE, TIMOLOL MALEATE TROPICAMIDE, TROPICAMIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 44 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAUSCH AND LOMB INC VYZULTA, LATANOPROSTENE BUNOD ZIRGAN, GANCICLOVIR ZYLET, LOTEPREDNOL ETABONATE * BAUSCH AND LOMB PHARMACEUTICALS INC BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXASPORIN, DEXAMETHASONE ERYTHROMYCIN, ERYTHROMYCIN FLUNISOLIDE, FLUNISOLIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC OFLOXACIN, OFLOXACIN OTICAIR, HYDROCORTISONE PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TIMOLOL MALEATE, TIMOLOL MALEATE TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE TOBRAMYCIN, TOBRAMYCIN TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE TROPICAMIDE, TROPICAMIDE BAUSCH AND LOMB INC * BAUSCH AND LOMB INC BEPREVE, BEPOTASTINE BESILATE LOTEMAX SM, LOTEPREDNOL ETABONATE LOTEMAX, LOTEPREDNOL ETABONATE LUMIFY, BRIMONIDINE TARTRATE (OTC) BAUSCH LOMB IRELAND * BAUSCH AND LOMB IRELAND LTD FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE, BENOXINATE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE BAXTER HLTHCARE * BAXTER HEALTHCARE CORP ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE BREVIBLOC, ESMOLOL HYDROCHLORIDE CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 45 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAXTER HEALTHCARE CORP CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER, CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE CYTOXAN, CYCLOPHOSPHAMIDE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE EXTRANEAL, FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FORANE, GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 46 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAXTER HEALTHCARE CORP HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN IFEX, LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE MESNEX, MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM NEXTERONE, AMIODARONE HYDROCHLORIDE NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 10% IN WATER, MANNITOL OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 15% IN WATER, MANNITOL OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 20% IN WATER, MANNITOL OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL OSMITROL 5% IN WATER, MANNITOL PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SEVOFLURANE, SEVOFLURANE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION STERILE WATER, STERILE WATER FOR IRRIGATION SUPRANE, TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE TIS-U-SOL, MAGNESIUM SULFATE TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 47 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAXTER HEALTHCARE CORP TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE * BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS BAXTER HLTHCARE CORP * BAXTER HEALTHCARE CORP BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, BIVALIRUDIN BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE CLINOLIPID 20%, DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE EPTIFIBATIDE, EPTIFIBATIDE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE , FLUMAZENIL FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FUROSEMIDE, FUROSEMIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOFLOXACIN, LEVOFLOXACIN MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TRANSDERM SCOP, * BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE PROTOPAM CHLORIDE, CHLORIDE * BAYER HEALTHCARE LLC ALEVE, NAPROXEN SODIUM (OTC) ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC) BAYER HEALTHCARE * BAYER HEALTHCARE PHARMACEUTICALS INC ALIQOPA, DIHYDROCHLORIDE LAMPIT, NIFURTIMOX NUBEQA, VITRAKVI, SULFATE BAYER HEALTHCARE LLC * BAYER HEALTHCARE LLC CHILDREN'S CLARITIN, LORATADINE (OTC) CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC) CLARITIN HIVES RELIEF, LORATADINE (OTC) CLARITIN REDITABS, LORATADINE (OTC) CLARITIN, LORATADINE (OTC) CLARITIN-D 24 HOUR, LORATADINE (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 48 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BAYER HEALTHCARE LLC CLARITIN-D, LORATADINE (OTC) LOTRIMIN ULTRA, HYDROCHLORIDE (OTC) MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC) ZEGERID OTC, OMEPRAZOLE (OTC) BAYER HLTHCARE * BAYER HEALTHCARE CONSUMER CARE ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) ASTEPRO ALLERGY, AZELASTINE HYDROCHLORIDE (OTC) CHILDREN'S ASTEPRO ALLERGY, AZELASTINE HYDROCHLORIDE (OTC) * BAYER HEALTHCARE PHARMACEUTICALS INC ADEMPAS, RIOCIGUAT ANGELIQ, DROSPIRENONE BEYAZ, DROSPIRENONE BILTRICIDE, CIPRO, CIPROFLOXACIN CIPRO, CIPROFLOXACIN HYDROCHLORIDE CLIMARA PRO, ESTRADIOL CLIMARA, ESTRADIOL EOVIST, GADOXETATE DISODIUM GADAVIST, GADOBUTROL KYLEENA, LEVONORGESTREL LEVITRA, VARDENAFIL HYDROCHLORIDE MENOSTAR, ESTRADIOL MIRENA, LEVONORGESTREL NATAZIA, NEXAVAR, TOSYLATE SAFYRAL, DROSPIRENONE SKYLA, LEVONORGESTREL STAXYN, VARDENAFIL HYDROCHLORIDE STIVARGA, ULTRAVIST (PHARMACY BULK), IOPROMIDE ULTRAVIST 300, IOPROMIDE ULTRAVIST 370, IOPROMIDE VITRAKVI, LAROTRECTINIB SULFATE XOFIGO, RADIUM RA-223 DICHLORIDE YASMIN, DROSPIRENONE YAZ, DROSPIRENONE BAYSHORE PHARMS LLC * BAYSHORE PHARMACEUTICALS LLC DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE ETODOLAC, ETODOLAC KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC) METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE METOLAZONE, METOLAZONE PINDOLOL, PINDOLOL PHOSPHATE, PRIMAQUINE PHOSPHATE BDSI * BIODELIVERY SCIENCES INTERNATIONAL INC BELBUCA, BUPRENORPHINE HYDROCHLORIDE SYMPROIC, NALDEMEDINE TOSYLATE BE PHARMS * BE PHARMACEUTICALS AG DAPTOMYCIN, DAPTOMYCIN FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE BECTON DICKINSON * BECTON DICKINSON AND CO CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC) E-Z SCRUB 201, POVIDONE-IODINE (OTC) E-Z SCRUB 241, POVIDONE-IODINE (OTC) BECTON DICKINSON CO * BECTON DICKINSON AND CO CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 49 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BECTON DICKINSON AND CO CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC) BEIGENE * BEIGENE USA INC BRUKINSA, BEIJING * BEIJING SCIECURE PHARMACEUTICAL CO LTD FLUVASTATIN SODIUM, FLUVASTATIN SODIUM BEIJING YILING * BEIJING YILING BIO-ENGEERING AND TECHNOLOGY CO LTD ANASTROZOLE, ANASTROZOLE LETROZOLE, LETROZOLE BELCHER * BELCHER PHARMACEUTICALS LLC ABLYSINOL, ALCOHOL CEFIXIME, CEFIXIME EPINEPHRINE, EPINEPHRINE MEFENAMIC ACID, MEFENAMIC ACID POTASSIUM CHLORIDE, POTASSIUM CHLORIDE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE TACROLIMUS, TACROLIMUS BELCHER PHARMS * BELCHER PHARMACEUTICALS LLC CEPHALEXIN, CEPHALEXIN , DESLORATADINE BELOTECA INC * BELOTECA INC DIAZEPAM, DIAZEPAM BENUVIA * BENUVIA THERAPEUTICS INC SYNDROS, DRONABINOL BEXIMCO PHARMS USA * BEXIMCO PHARMACEUTICALS USA INC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE LOVASTATIN, LOVASTATIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL NADOLOL, NADOLOL SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE BEXIMCO USA * BEXIMCO PHARMACEUTICALS USA INC CARVEDILOL, CARVEDILOL BIOCODEX SA * BIOCODEX SA DIACOMIT, LTD * BIOCON LTD ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM BIOCON PHARMA * BIOCON PHARMA INC PRAVASTATIN SODIUM, PRAVASTATIN SODIUM * BIOCON PHARMA LTD SIMVASTATIN, SIMVASTATIN TACROLIMUS, TACROLIMUS BIOCRYST * BIOCRYST PHARMACEUTICALS INC ORLADEYO, BEROTRALSTAT HYDROCHLORIDE RAPIVAB, PERAMIVIR BIOFRONTERA * BIOFRONTERA BIOSCIENCE GMBH

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 50 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BIOFRONTERA BIOSCIENCE GMBH AMELUZ, HYDROCHLORIDE IDEC * BIOGEN IDEC INC SPINRAZA, NUSINERSEN SODIUM BIOGEN INC * BIOGEN INC TECFIDERA, DIMETHYL FUMARATE VUMERITY, DIROXIMEL FUMARATE BIOHAVEN PHARM * BIOHAVEN PHARMACEUTICAL HOLDING CO LTD NURTEC ODT, SULFATE BIOMARIN PHARM * BIOMARIN PHARMACEUTICAL INC KUVAN, SAPROPTERIN DIHYDROCHLORIDE BIOMEDCL RES FDN * BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 BIONPHARMA INC * BIONPHARMA INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMPHETAMINE SULFATE, AMPHETAMINE SULFATE ATOVAQUONE, ATOVAQUONE AZITHROMYCIN, AZITHROMYCIN BENZONATATE, BENZONATATE BEXAROTENE, BEXAROTENE CALCITRIOL, CALCITRIOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLOBAZAM, CLOBAZAM COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE DEFERASIROX, DEFERASIROX DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DOFETILIDE, DOFETILIDE DROXIDOPA, DROXIDOPA DUTASTERIDE, DUTASTERIDE ETHOSUXIMIDE, ETHOSUXIMIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MIDOL LIQUID , IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NIMODIPINE, NIMODIPINE OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PARICALCITOL, PARICALCITOL POTASSIUM CITRATE, POTASSIUM CITRATE PROGESTERONE, PROGESTERONE RUFINAMIDE, RUFINAMIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE TETRABENAZINE, TETRABENAZINE VALPROIC ACID, VALPROIC ACID D, ERGOCALCIFEROL ZONISAMIDE, ZONISAMIDE BLAIREX * BLAIREX LABORATORIES INC BRONCHO , SODIUM CHLORIDE (OTC) BLUE EARTH * BLUE EARTH DIAGNOSTICS LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 51 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BLUE EARTH DIAGNOSTICS LTD AXUMIN, FLUCICLOVINE F-18 BLUEPRINT * BLUEPRINT MEDICINES CORP AYVAKIT, * BOEHRINGER INGELHEIM CATAPRES, CLONIDINE HYDROCHLORIDE GILOTRIF, DIMALEATE GLYXAMBI, MICARDIS HCT, HYDROCHLOROTHIAZIDE MICARDIS, TELMISARTAN MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE * BOEHRINGER INGELHEIM PHARMACEUTICALS INC AGGRENOX, ASPIRIN APTIVUS, TIPRANAVIR ATROVENT HFA, IPRATROPIUM BROMIDE COMBIVENT RESPIMAT, ALBUTEROL SULFATE JARDIANCE, EMPAGLIFLOZIN JENTADUETO XR, JENTADUETO, LINAGLIPTIN MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE MOBIC, MELOXICAM OFEV, ESYLATE PERSANTINE, DIPYRIDAMOLE PRADAXA, DABIGATRAN ETEXILATE MESYLATE SPIRIVA RESPIMAT, SPIRIVA, TIOTROPIUM BROMIDE STIOLTO RESPIMAT, HYDROCHLORIDE STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE SYNJARDY XR, EMPAGLIFLOZIN SYNJARDY, EMPAGLIFLOZIN TRADJENTA, LINAGLIPTIN TRIJARDY XR, EMPAGLIFLOZIN TWYNSTA, AMLODIPINE BESYLATE VIRAMUNE XR, NEVIRAPINE VIRAMUNE, NEVIRAPINE BOSCOGEN * BOSCOGEN INC ARIPIPRAZOLE, ARIPIPRAZOLE CAPTOPRIL, CAPTOPRIL CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE REPAGLINIDE, REPAGLINIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE BPI LABS LLC * BPI LABS LLC MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID BRACCO * BRACCO DIAGNOSTICS INC CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82 CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT CYSTOGRAFIN DILUTE, DIATRIZOATE CYSTOGRAFIN, DIATRIZOATE MEGLUMINE E-Z-HD, SULFATE E-Z-PAQUE, BARIUM SULFATE ENTERO VU 24%, BARIUM SULFATE GASTROGRAFIN, DIATRIZOATE MEGLUMINE ISOVUE-200, IOPAMIDOL ISOVUE-250, IOPAMIDOL ISOVUE-300, IOPAMIDOL ISOVUE-370, IOPAMIDOL ISOVUE-M 200, IOPAMIDOL ISOVUE-M 300, IOPAMIDOL KINEVAC, SINCALIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 52 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BRACCO DIAGNOSTICS INC LIQUID E-Z-PAQUE, BARIUM SULFATE LUMASON, HEXAFLUORIDE -TYPE A MICROSPHERES MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE MULTIHANCE, GADOBENATE DIMEGLUMINE PROHANCE MULTIPACK, GADOTERIDOL PROHANCE, GADOTERIDOL READI-CAT 2 SMOOTHIE, BARIUM SULFATE READI-CAT 2, BARIUM SULFATE TAGITOL V, BARIUM SULFATE VARIBAR HONEY, BARIUM SULFATE VARIBAR NECTAR, BARIUM SULFATE VARIBAR PUDDING, BARIUM SULFATE VARIBAR THIN HONEY, BARIUM SULFATE VARIBAR THIN LIQUID, BARIUM SULFATE BRAINTREE * BRAINTREE LABORATORIES INC GOLYTELY, POLYETHYLENE GLYCOL 3350 NULYTELY, POLYETHYLENE GLYCOL 3350 NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350 BRAINTREE LABS * BRAINTREE LABORATORIES INC SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE SUTAB (COPACKAGED), MAGNESIUM SULFATE BRECKENRIDGE * BRECKENRIDGE PHARMACEUTICAL INC ACETAZOLAMIDE, ACETAZOLAMIDE ALPRAZOLAM, ALPRAZOLAM ASENAPINE MALEATE, ASENAPINE MALEATE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE TOSYLATE, BRETYLIUM TOSYLATE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN , CARFILZOMIB CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CLOBAZAM, CLOBAZAM DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENTECAVIR, ENTECAVIR EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE EPLERENONE, EPLERENONE , EVEROLIMUS EXEMESTANE, EXEMESTANE IMATINIB MESYLATE, IMATINIB MESYLATE LEVETIRACETAM, LEVETIRACETAM MEGESTROL ACETATE, MEGESTROL ACETATE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OMEPRAZOLE, OMEPRAZOLE RIVASTIGMINE, RIVASTIGMINE ROFLUMILAST, ROFLUMILAST SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE BRECKENRIDGE PHARM * BRECKENRIDGE PHARMACEUTICAL INC ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE OXCARBAZEPINE, OXCARBAZEPINE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE BRIGHAM WOMENS * BRIGHAM AND WOMENS HOSP FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 BRIGHAM WOMENS HOSP

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 53 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B ** * BRIGHAM AND WOMENS HOSP INC AMMONIA N 13, AMMONIA N-13 BRIGHTGENE * BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD ENTECAVIR, ENTECAVIR BRISTOL MYERS SQUIBB * BRISTOL MYERS SQUIBB AZACTAM, AZTREONAM BARACLUDE, ENTECAVIR * BRISTOL MYERS SQUIBB CO DROXIA, HYDROXYUREA HYDREA, HYDROXYUREA REYATAZ, ATAZANAVIR SULFATE SPRYCEL, SUSTIVA, EFAVIRENZ * BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE ELIQUIS, APIXABAN BRISTOL-MYERS SQUIBB * BRISTOL-MYERS SQUIBB CO EVOTAZ, ATAZANAVIR SULFATE BTCP PHARMA * BTCP PHARMA LLC LAZANDA, FENTANYL CITRATE SUBSYS, FENTANYL BWXT ITG * BWXT ITG INC INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

** C ** CADILA * LTD ACETAZOLAMIDE, ACETAZOLAMIDE ACYCLOVIR, ACYCLOVIR BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE DICLOFENAC SODIUM, DICLOFENAC SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DUTASTERIDE, DUTASTERIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FELBAMATE, FELBAMATE FLUOCINONIDE, FLUOCINONIDE GEMFIBROZIL, GEMFIBROZIL INDOMETHACIN, INDOMETHACIN LEVOFLOXACIN, LEVOFLOXACIN MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE MODAFINIL, MODAFINIL NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN , PIROXICAM RANOLAZINE, RANOLAZINE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VORICONAZOLE, VORICONAZOLE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE CADILA PHARMS LTD * CADILA PHARMACEUTICALS LTD ACYCLOVIR, ACYCLOVIR BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 54 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CADILA PHARMACEUTICALS LTD CELECOXIB, CELECOXIB DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID GEMFIBROZIL, GEMFIBROZIL GLYBURIDE, GLYBURIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE , NATEGLINIDE OFLOXACIN, OFLOXACIN RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM TELMISARTAN, TELMISARTAN TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE CALL INC * CALL INC DBA ROCHESTER PHARMACEUTICALS ADAPALENE, ADAPALENE CAPELLON PHARMS LLC * CAPELLON PHARMACEUTICALS LLC POLMON, MALEATE CAPLIN * CAPLIN STERILES LTD ARGATROBAN, ARGATROBAN GLYCOPYRROLATE, GLYCOPYRROLATE MILRINONE LACTATE, MILRINONE LACTATE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE CARDINAL HEALTH 414 * CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT CARDINAL HEALTH 418 * CARDINAL HEALTH 418 INC I 123, SODIUM IODIDE I-123 CARDINAL HLTH 414 * CARDINAL HEALTH 414 LLC AMMONIA N 13, AMMONIA N-13 CARIBE HOLDINGS * CARIBE HOLDINGS CAYMAN CO LTD DBA PURACAP CARIBE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GEMFIBROZIL, GEMFIBROZIL CARLSBAD * CARLSBAD TECHNOLOGY INC ACYCLOVIR, ACYCLOVIR CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM FAMOTIDINE, FAMOTIDINE GLIMEPIRIDE, GLIMEPIRIDE LOVASTATIN, LOVASTATIN CARLSBAD TECHNOLOGY * CARLSBAD TECHNOLOGY INC ACYCLOVIR, ACYCLOVIR CASI PHARMS INC * CASI PHARMACEUTICALS INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 55 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CASI PHARMACEUTICALS INC CILOSTAZOL, CILOSTAZOL ENTECAVIR, ENTECAVIR ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE CASPER PHARMA LLC * CASPER PHARMA LLC ANTIVERT, MECLIZINE HYDROCHLORIDE AQUASOL A, PALMITATE CASPORYN HC, HYDROCORTISONE FURADANTIN, NITROFURANTOIN LUMI-SPORYN, BACITRACIN ZINC ROBINUL FORTE, GLYCOPYRROLATE ROBINUL, GLYCOPYRROLATE THALITONE, CHLORTHALIDONE ZYLOPRIM, ALLOPURINOL * CATALENT PHARMA SOLUTIONS LLC NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) VALPROIC ACID, VALPROIC ACID CATALYST PHARMS * CATALYST PHARMACEUTICALS INC FIRDAPSE, PHOSPHATE CEDIPROF INC * CEDIPROF INC DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE LEVO-T, LEVOTHYROXINE SODIUM ** CELATOR PHARMS * CELATOR PHARMACEUTICALS INC VYXEOS, CELGENE * CELGENE CORP ISTODAX, POMALYST, REVLIMID, THALOMID, VIDAZA, AZACITIDINE CELGENE CORP * CELGENE CORP IDHIFA, MESYLATE ONUREG, AZACITIDINE CELGENE INTL * CELGENE INTERNATIONAL II SARL ZEPOSIA, OZANIMOD HYDROCHLORIDE CELLTRION * CELLTRION INC DEFERASIROX, DEFERASIROX DIVALPROEX SODIUM, DIVALPROEX SODIUM FAMOTIDINE, FAMOTIDINE LEVOFLOXACIN, LEVOFLOXACIN LINEZOLID, LINEZOLID MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PREGABALIN, PREGABALIN RISPERIDONE, RISPERIDONE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TELMISARTAN, TELMISARTAN TEMIXYS, LAMIVUDINE CENTAUR PHARMS PVT * CENTAUR PHARMACEUTICALS PRIVATE LTD LAMIVUDINE, LAMIVUDINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 56 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CEPHALON INC ACTIQ, FENTANYL CITRATE FENTORA, FENTANYL CITRATE GABITRIL, TIAGABINE HYDROCHLORIDE NUVIGIL, ARMODAFINIL PROVIGIL, MODAFINIL TREANDA, HYDROCHLORIDE TRISENOX, ARSENIC TRIOXIDE CEROVENE INC * CEROVENE INC AMPHETAMINE SULFATE, AMPHETAMINE SULFATE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE , PYRIMETHAMINE CHANGZHOU PHARM * CHANGZHOU PHARMACEUTICAL FACTORY DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM CHARTWELL * CHARTWELL LIFE LLC ALLOPURINOL, ALLOPURINOL AMOXICILLIN, AMOXICILLIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN COLOCORT, HYDROCORTISONE FLUCONAZOLE, FLUCONAZOLE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OXAPROZIN, OXAPROZIN TEMOZOLOMIDE, TEMOZOLOMIDE * CHARTWELL PHARMA SCIENCE LLC SULFASALAZINE, SULFASALAZINE * CHARTWELL SCHEDULED LLC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN CHARTWELL MOLECULAR * CHARTWELL MOLECULAR HOLDINGS LLC CALCIUM ACETATE, CALCIUM ACETATE CARVEDILOL, CARVEDILOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE FOLIC ACID, FOLIC ACID GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IRBESARTAN, IRBESARTAN RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE CHARTWELL MOLECULES * CHARTWELL MOLECULES LLC DISULFIRAM, DISULFIRAM GEMFIBROZIL, GEMFIBROZIL NABUMETONE, NABUMETONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE CHARTWELL RX * CHARTWELL RX SCIENCES LLC BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CALCIUM ACETATE, CALCIUM ACETATE CEFPROZIL, CEFPROZIL CILOSTAZOL, CILOSTAZOL DUVOID, BETHANECHOL CHLORIDE EPLERENONE, EPLERENONE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE INDOMETHACIN, INDOMETHACIN LACTULOSE, LACTULOSE LEVETIRACETAM, LEVETIRACETAM LISINOPRIL, LISINOPRIL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 57 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CHARTWELL RX SCIENCES LLC METHIMAZOLE, METHIMAZOLE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MONODOX, DOXYCYCLINE NABUMETONE, NABUMETONE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE REPAGLINIDE, REPAGLINIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE VALPROIC ACID, VALPROIC ACID CHARTWELL TETRA * CHARTWELL TETRA LLC TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE CHATTEM * CHATTEM INC UNISOM, DOXYLAMINE SUCCINATE (OTC) CHEMI SPA * CHEMI SPA DECITABINE, DECITABINE TEMOZOLOMIDE, TEMOZOLOMIDE CHEMISCH FBRK KRSSLR * CHEMISCHE FABRIK KREUSSLER & CO. GMBH ASCLERA, CHEMO RESEARCH SL * CHEMO RESEARCH SL BENZNIDAZOLE, BENZNIDAZOLE NUVESSA, METRONIDAZOLE CHEPLAPHARM * CHEPLAPHARM ARZNEIMITTEL GMBH CYTOVENE, GANCICLOVIR SODIUM ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE XENICAL, CHIA TAI TIANQING * CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FULVESTRANT, FULVESTRANT CHIASMA * CHIASMA INC MYCAPSSA, ACETATE CHIESI * CHIESI USA INC BETHKIS, TOBRAMYCIN BRONCHITOL, MANNITOL CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE CLEVIPREX, FERRIPROX, KENGREAL, ZYFLO CR, ZILEUTON ZYFLO, ZILEUTON CHILDRENS HOSP MI * CHILDRENS HOSP MICHIGAN FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 CHIMERIX * CHIMERIX INC TEMBEXA, BRINCIDOFOVIR CHINA RESOURCES * CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CHIRHOCLIN * CHIRHOCLIN INC CHIRHOSTIM, SYNTHETIC HUMAN CINTEX SVCS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 58 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CINTEX SERVICES LLC DESONIDE, DESONIDE FLURANDRENOLIDE, FLURANDRENOLIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE CIPHER PHARMS INC * CIPHER PHARMACEUTICALS INC CONZIP, TRAMADOL HYDROCHLORIDE LIPOFEN, FENOFIBRATE * CIPLA LTD ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE ABACAVIR SULFATE, ABACAVIR SULFATE ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM , AMBRISENTAN AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE ATAZANAVIR SULFATE, ATAZANAVIR SULFATE AZACITIDINE, AZACITIDINE SULFATE, BLEOMYCIN SULFATE BUDESONIDE, BUDESONIDE CELECOXIB, CELECOXIB CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE DEFERASIROX, DEFERASIROX DICLOFENAC SODIUM, DICLOFENAC SODIUM DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE DIMETHYL FUMARATE, DIMETHYL FUMARATE EFAVIRENZ, EFAVIRENZ EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE EMTRICITABINE, EMTRICITABINE ENTECAVIR, ENTECAVIR ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM EXEMESTANE, EXEMESTANE FAMCICLOVIR, FAMCICLOVIR FENOFIBRATE, FENOFIBRATE FINASTERIDE, FINASTERIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE ACETATE, ICATIBANT ACETATE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE MELOXICAM, MELOXICAM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MONTELUKAST SODIUM, MONTELUKAST SODIUM NEVIRAPINE, NEVIRAPINE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREGABALIN, PREGABALIN SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE SUMATRIPTAN, SUMATRIPTAN TADALAFIL, TADALAFIL TAVABOROLE, TAVABOROLE TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE, TESTOSTERONE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 59 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CIPLA LTD TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE ZIDOVUDINE, ZIDOVUDINE CIPLA LTD * CIPLA LTD ALBENDAZOLE, ALBENDAZOLE CARBOPLATIN, CARBOPLATIN DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN TOPIRAMATE, TOPIRAMATE ZALEPLON, ZALEPLON ZIDOVUDINE, ZIDOVUDINE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE CIPLA USA * CIPLA USA INC ZEMDRI, SULFATE CISEN * CISEN PHARMACEUTICAL CO LTD ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM CLARUS * CLARUS THERAPEUTICS INC JATENZO, CLINIGEN * CLINIGEN INC ETHYOL, TOTECT, DEXRAZOXANE HYDROCHLORIDE CLINIGEN HLTHCARE * CLINIGEN HEALTHCARE LTD FOSCAVIR, FOSCARNET SODIUM CLIVUNEL INC * CLINUVEL INC SCENESSE, CLOVIS INC * CLOVIS ONCOLOGY INC RUBRACA, CAMSYLATE CMP DEV LLC * CMP DEVELOPMENT LLC CAROSPIR, SPIRONOLACTONE POTASSIUM , POTASSIUM PHOSPHATE, DIBASIC CMP PHARMA INC * CMP PHARMA INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE ISONIAZID, ISONIAZID SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE SPS, SODIUM POLYSTYRENE SULFONATE TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE CNTY LINE PHARMS * COUNTY LINE PHARMACEUTICALS LLC TRANDATE, LABETALOL HYDROCHLORIDE UREX, METHENAMINE HIPPURATE CODY LABS INC * CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC NUMBRINO, HYDROCHLORIDE COEPTIS * COEPTIS PHARMACEUTICALS INC CONSENSI, AMLODIPINE BESYLATE COLGATE PALMOLIVE CO * COLGATE PALMOLIVE CO PERIOGARD, CHLORHEXIDINE GLUCONATE COLGATE-PALMOLIVE CO

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 60 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * COLGATE-PALMOLIVE CO PERIOGARD, CHLORHEXIDINE GLUCONATE COLLEGIUM PHARM INC * COLLEGIUM PHARMACEUTICAL INC NUCYNTA ER, HYDROCHLORIDE NUCYNTA, TAPENTADOL HYDROCHLORIDE XTAMPZA ER, OXYCODONE COMBE * COMBE INC VAGISTAT-1, (OTC) COMMAVE THERAP * COMMAVE THERAPEUTICS SA AZSTARYS, DEXMETHYLPHENIDATE HYDROCHLORIDE CONCORD BIOTECH LTD * CONCORD BIOTECH LTD MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL MYCOPHENOLIC ACID, MYCOPHENOLIC ACID TACROLIMUS, TACROLIMUS CONCORDIA * CONCORDIA PHARMACEUTICALS INC DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE DYRENIUM, TRIAMTERENE LANOXIN, NILANDRON, NILUTAMIDE PANRETIN, PARNATE, SULFATE PLAQUENIL, HYDROXYCHLOROQUINE SULFATE SALAGEN, PILOCARPINE HYDROCHLORIDE UROXATRAL, ALFUZOSIN HYDROCHLORIDE ZONEGRAN, ZONISAMIDE CONCORDIA PHARMS INC * CONCORDIA PHARMACEUTICALS INC KAPVAY, CLONIDINE HYDROCHLORIDE ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE CONTRACT PHARMACAL * CONTRACT PHARMACAL CORP CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) COOPERSURGICAL * COOPERSURGICAL INC PARAGARD T 380A, CORCEPT THERAP * CORCEPT THERAPEUTICS INC KORLYM, CORDEN PHARMA * CORDEN PHARMA LATINA SPA GLEOSTINE, COREPHARMA * COREPHARMA LLC LISINOPRIL, LISINOPRIL LOVASTATIN, LOVASTATIN SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TORSEMIDE, TORSEMIDE COSETTE * COSETTE PHARMACEUTICALS INC ACEPHEN, ACETAMINOPHEN (OTC) ACYCLOVIR, ACYCLOVIR ALBUTEROL SULFATE, ALBUTEROL SULFATE BETA-VAL, BETAMETHASONE VALERATE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 61 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * COSETTE PHARMACEUTICALS INC CICLOPIROX, CICLOPIROX CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE DOXYCYCLINE, DOXYCYCLINE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE EMULSIFIED , FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GENTAMICIN SULFATE, GENTAMICIN SULFATE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL , HYDROCORTISONE VALERATE INDOMETHACIN, INDOMETHACIN LIDOCAINE, LIDOCAINE METRONIDAZOLE, METRONIDAZOLE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MIGERGOT, CAFFEINE MOMETASONE FUROATE, MOMETASONE FUROATE MYKACET, NYSTATIN NYSTATIN, NYSTATIN PROCHLORPERAZINE, PROCHLORPERAZINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE TAZAROTENE, TAZAROTENE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE COVIS * COVIS PHARMA GMBH ALTOPREV, LOVASTATIN ALVESCO, BETAPACE AF, SOTALOL HYDROCHLORIDE BETAPACE, SOTALOL HYDROCHLORIDE FERAHEME, FERUMOXYTOL LANOXIN PEDIATRIC, DIGOXIN LANOXIN, DIGOXIN MAKENA (AUTOINJECTOR), HYDROXYPROGESTERONE CAPROATE MAKENA PRESERVATIVE FREE, HYDROXYPROGESTERONE CAPROATE MAKENA, HYDROXYPROGESTERONE CAPROATE OMNARIS, CICLESONIDE PRILOSEC, OMEPRAZOLE MAGNESIUM RILUTEK, RILUZOLE SULAR, ZANAFLEX, TIZANIDINE HYDROCHLORIDE ZETONNA, CICLESONIDE CPDC * CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 CPPI CV * CP PHARMACEUTICALS INTERNATIONAL CV SUTENT, MALATE CROSSMEDIKA SA * CROSSMEDIKA SA MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE MALEATE, TRIMIPRAMINE MALEATE VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE CROWN LABS * CROWN LABORATORIES INC ALA-CORT, HYDROCORTISONE TRIDERM, TRIAMCINOLONE ACETONIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 62 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** CROWN LABS INC * CROWN LABORATORIES INC NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN CSPC OUYI * CSPC OUYI PHARMACEUTICAL CO LTD AZITHROMYCIN, AZITHROMYCIN CARBAMAZEPINE, CARBAMAZEPINE CELECOXIB, CELECOXIB CONJUPRI, MALEATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM GABAPENTIN, GABAPENTIN MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PALIPERIDONE, PALIPERIDONE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PREGABALIN, PREGABALIN CSPC OUYI PHARM CO * CSPC OUYI PHARMACEUTICAL CO LTD TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE CSPC-NBP PHARM * CSPC-NBP PHARMACEUTICAL CO LTD BENZONATATE, BENZONATATE OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS CUBIST PHARMS * INC ENTEREG, ALVIMOPAN CUBIST PHARMS LLC * CUBIST PHARMACEUTICALS LLC CUBICIN RF, DAPTOMYCIN CUBICIN, DAPTOMYCIN DIFICID, SIVEXTRO, PHOSPHATE ZERBAXA, CEFTOLOZANE SULFATE CUMBERLAND PHARMS * CUMBERLAND PHARMACEUTICALS INC ACETADOTE, ACETYLCYSTEINE CALDOLOR, IBUPROFEN LACTULOSE, LACTULOSE REDITREX, METHOTREXATE VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, HYDROCHLORIDE VIBATIV, TELAVANCIN HYDROCHLORIDE CURIUM * CURIUM US LLC GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT SODIUM IODIDE I 123, SODIUM IODIDE I-123 TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR ULTRATAG, TECHNETIUM TC-99M RED KIT XE 133, XENON XE-133 CURRAX * CURRAX PHARMACEUTICALS LLC ONZETRA XSAIL, SUMATRIPTAN SUCCINATE SILENOR, DOXEPIN HYDROCHLORIDE TREXIMET, NAPROXEN SODIUM CUSTOPHARM INC * CUSTOPHARM INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 63 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C ** * CUSTOPHARM INC ACETAMINOPHEN, ACETAMINOPHEN CALCITONIN-SALMON, CALCITONIN SALMON DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM SODIUM TETRADECYL SULFATE, SODIUM TETRADECYL SULFATE , VALRUBICIN CYCLE PHARMS LTD * CYCLE PHARMACEUTICALS LTD HALOPERIDOL, HALOPERIDOL KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE NITYR,

** D ** DAEWOONG PHARM CO * DAEWOONG PHARMACEUTICAL CO LTD MEROPENEM, MEROPENEM DAIICHI SANKYO * DAIICHI SANKYO INC AZOR, AMLODIPINE BESYLATE BENICAR HCT, HYDROCHLOROTHIAZIDE BENICAR, OLMESARTAN MEDOXOMIL TRIBENZOR, AMLODIPINE BESYLATE WELCHOL, COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO INC * DAIICHI SANKYO INC EFFIENT, PRASUGREL HYDROCHLORIDE EVOXAC, HYDROCHLORIDE SAVAYSA, TOSYLATE TURALIO, HYDROCHLORIDE DANCO LABS LLC * LLC MIFEPREX, MIFEPRISTONE DASH PHARMS * DASH PHARMACEUTICALS LLC TESTOSTERONE, TESTOSTERONE DAVA PHARMS INC * DAVA PHARMACEUTICALS INC ACYCLOVIR, ACYCLOVIR AMOXICILLIN, AMOXICILLIN MORPHINE SULFATE, MORPHINE SULFATE PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PROPYLTHIOURACIL, PROPYLTHIOURACIL VOSPIRE ER, ALBUTEROL SULFATE DAVIS AND GECK * DAVIS AND GECK DIV AMERICAN CYANAMID CO PRE-OP II, PRE-OP, HEXACHLOROPHENE DBL PHARMS * DBL PHARMACEUTICALS INC METHOCARBAMOL, METHOCARBAMOL DECATUR * DECATUR MEMORIAL HOSP AMMONIA N 13, AMMONIA N-13 CHOLINE C-11, CHOLINE C-11 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 DECIPHERA PHARMS * DECIPHERA PHARMACEUTICALS LLC QINLOCK, DEN-MAT

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 64 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D ** * DEN-MAT HOLDINGS LLC ATRIDOX, DOXYCYCLINE HYCLATE DENTSPLY PHARM * DENTSPLY PHARMACEUTICAL INC CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE ORAQIX, LIDOCAINE DEPROCO * DEPROCO INC LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, HYDROCHLORIDE SEPTOCAINE, HYDROCHLORIDE DEVA HOLDING AS * DEVA HOLDING AS ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TEMOZOLOMIDE, TEMOZOLOMIDE DEXCEL LTD * DEXCEL LTD DICLOFENAC SODIUM, DICLOFENAC SODIUM ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE DEXCEL PHARMA * DEXCEL PHARMA TECHNOLOGIES LTD DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) HEMADY, DEXAMETHASONE LANSOPRAZOLE, LANSOPRAZOLE (OTC) OMEPRAZOLE, OMEPRAZOLE (OTC) PERIOCHIP, CHLORHEXIDINE GLUCONATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VIGABATRIN, VIGABATRIN DIALYSIS SUPS * DIALYSIS SUPPLIES INC NORMOCARB HF 25, MAGNESIUM CHLORIDE NORMOCARB HF 35, MAGNESIUM CHLORIDE DISCOVERY THERAP * DISCOVERY THERAPEUTICS LLC BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE DORC * DORC INTERNATIONAL BV MEMBRANEBLUE, VISIONBLUE, TRYPAN BLUE DOUGLAS PHARMS * DOUGLAS PHARMACEUTICALS AMERICA LTD MYORISAN, ISOTRETINOIN DOW PHARM * DOW PHARMACEUTICAL SCIENCES ALTRENO, TRETINOIN ATRALIN, TRETINOIN DR REDDYS * DR REDDYS LABORATORIES INC CHLORTHALIDONE, CHLORTHALIDONE FENOFIBRATE, FENOFIBRATE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE ICOSAPENT ETHYL, ICOSAPENT ETHYL METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE NITROGLYCERIN, NITROGLYCERIN PROGESTERONE, PROGESTERONE , PROPOFOL SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 65 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D ** * DR REDDYS LABORATORIES INC TESTOSTERONE, TESTOSTERONE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * DR REDDYS LABORATORIES LTD ALBENDAZOLE, ALBENDAZOLE AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE ASPIRIN AND DIPYRIDAMOLE, ASPIRIN AZACITIDINE, AZACITIDINE CARFILZOMIB, CARFILZOMIB CARMUSTINE, CARMUSTINE CHLORDIAZEPOXIDE HYDROCHLORIDE AND , CHLORDIAZEPOXIDE HYDROCHLORIDE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE COLCHICINE, COLCHICINE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE DAPTOMYCIN, DAPTOMYCIN DECITABINE, DECITABINE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FULVESTRANT, FULVESTRANT GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IMATINIB MESYLATE, IMATINIB MESYLATE LIDOCAINE, LIDOCAINE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN OMEPRAZOLE, OMEPRAZOLE (OTC) PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM , PANCURONIUM BROMIDE PARICALCITOL, PARICALCITOL PENICILLAMINE, PENICILLAMINE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PREGABALIN, PREGABALIN RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN DIHYDROCHLORIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TETRABENAZINE, TETRABENAZINE THIOTEPA, THIOTEPA VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE VIGABATRIN, VIGABATRIN VINORELBINE TARTRATE, VINORELBINE TARTRATE DR REDDYS LA * DR REDDYS LABORATORIES LOUISIANA LLC IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LOPURIN, ALLOPURINOL SSD, SILVER DR REDDYS LABS INC * DR REDDYS LABORATORIES INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE FINASTERIDE, FINASTERIDE FLUCONAZOLE, FLUCONAZOLE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LEVOFLOXACIN, LEVOFLOXACIN MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SIMVASTATIN, SIMVASTATIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 66 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D ** * DR REDDYS LABORATORIES INC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS LTD * DR REDDYS LABORATORIES LIMITED LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE * DR REDDYS LABORATORIES LTD ABIRATERONE ACETATE, ABIRATERONE ACETATE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM BIVALIRUDIN, BIVALIRUDIN , BORTEZOMIB CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CAPECITABINE, CAPECITABINE CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CIPROFLOXACIN AND DEXAMETHASONE, CIPROFLOXACIN CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOFARABINE, CLOFARABINE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOCETAXEL, DOCETAXEL DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE EPHEDRINE SULFATE, EPHEDRINE SULFATE , ESLICARBAZEPINE ACETATE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) ESZOPICLONE, ESZOPICLONE FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) FEBUXOSTAT, FEBUXOSTAT FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FONDAPARINUX SODIUM, FONDAPARINUX SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC) IBANDRONATE SODIUM, IBANDRONATE SODIUM IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE LANSOPRAZOLE, LANSOPRAZOLE (OTC) LATANOPROST, LATANOPROST LETROZOLE, LETROZOLE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 67 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D ** * DR REDDYS LABORATORIES LTD LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM NAPROXEN SODIUM, NAPROXEN SODIUM NATEGLINIDE, NATEGLINIDE NIZATIDINE, NIZATIDINE OFLOXACIN, OFLOXACIN OLANZAPINE, OLANZAPINE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXAPROZIN, OXAPROZIN PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PARICALCITOL, PARICALCITOL PHYTONADIONE, PHYTONADIONE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RAMIPRIL, RAMIPRIL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE SIROLIMUS, SIROLIMUS SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE TACROLIMUS, TACROLIMUS TADALAFIL, TADALAFIL TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VIGABATRIN, VIGABATRIN ZAFIRLUKAST, ZAFIRLUKAST ZENATANE, ISOTRETINOIN ZOLEDRONIC ACID, ZOLEDRONIC ACID DR REDDYS LABS SA * DR REDDYS LABORATORIES SA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE EZETIMIBE AND SIMVASTATIN, EZETIMIBE FENOFIBRATE (MICRONIZED), FENOFIBRATE HABITROL, NICOTINE (OTC) , MERCAPTOPURINE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) RAMELTEON, RAMELTEON TOBRAMYCIN, TOBRAMYCIN DUCHESNAY * DUCHESNAY INC BONJESTA, DOXYLAMINE SUCCINATE DICLEGIS, DOXYLAMINE SUCCINATE OSPHENA, DURAMED PHARMS BARR * DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC AVIANE-28, ETHINYL ESTRADIOL CRYSELLE, ETHINYL ESTRADIOL DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL ENPRESSE-28, ETHINYL ESTRADIOL VELIVET, DESOGESTREL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 68 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D ** DUSA * DUSA PHARMACEUTICALS INC LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE DUTCH OPHTHALMIC * DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV TISSUEBLUE, BRILLIANT BLUE G REDDYS * DOCTOR REDDYS LABORATORIES LTD DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

** E ** E5 PHARMA INC * E5 PHARMA INC , DIAZOXIDE EAGLE PHARMS * EAGLE PHARMACEUTICALS INC BELRAPZO, BENDAMUSTINE HYDROCHLORIDE BENDEKA, BENDAMUSTINE HYDROCHLORIDE PEMFEXY, RYANODEX, DANTROLENE SODIUM ECI PHARMS LLC * ECI PHARMACEUTICALS LLC CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE ECOLAB * ECOLAB INC CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC) CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC) ECR * ECR PHARMACEUTICALS DEXAMETHASONE, DEXAMETHASONE ECR PHARMA * ECR PHARMA TUSSICAPS, CHLORPHENIRAMINE POLISTIREX EDENBRIDGE PHARMS * EDENBRIDGE PHARMACEUTICALS LLC ALBENDAZOLE, ALBENDAZOLE AMINOCAPROIC ACID, AMINOCAPROIC ACID BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE CARBIDOPA, CARBIDOPA DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE ETHACRYNIC ACID, ETHACRYNIC ACID ETODOLAC, ETODOLAC IVERMECTIN, IVERMECTIN MIGLUSTAT, MIGLUSTAT PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE , TINIDAZOLE EDISON THERAPS LLC * EDISON THERAPEUTICS LLC METHERGINE, METHYLERGONOVINE MALEATE EGALET * EGALET US INC INDOCIN, INDOMETHACIN EI INC * EI INC THEROXIDIL, MINOXIDIL (OTC) EIGER BIOPHARMS * EIGER INC ZOKINVY, LONAFARNIB EIRGEN * EIRGEN PHARMA LTD RAYALDEE, CALCIFEDIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 69 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E ** EISAI INC * EISAI INC ACIPHEX, RABEPRAZOLE SODIUM ARICEPT, DONEPEZIL HYDROCHLORIDE BANZEL, RUFINAMIDE DAYVIGO, FYCOMPA, HALAVEN, MESYLATE LENVIMA, MESYLATE ELI LILLY AND CO * ELI LILLY AND CO BAQSIMI, GLUCAGON OLUMIANT, PROZAC, FLUOXETINE HYDROCHLORIDE REYVOW, SUCCINATE VERZENIO, ELI LILLY CO * ELI LILLY CO ADCIRCA, TADALAFIL ZYPREXA RELPREVV, OLANZAPINE PAMOATE ELITE LABS * ELITE LABORATORIES INC NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE ELITE LABS INC * ELITE LABORATORIES INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN DANTROLENE SODIUM, DANTROLENE SODIUM DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE , ISRADIPINE LOXAPINE SUCCINATE, LOXAPINE SUCCINATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE ELYSIUM * ELYSIUM PHARMACEUTICALS LTD CALCITRIOL, CALCITRIOL CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE TIMOLOL MALEATE, TIMOLOL MALEATE EMCURE PHARMS LTD * EMCURE PHARMACEUTICALS LTD ACARBOSE, ACARBOSE ADENOSINE, ADENOSINE SULFATE, AMIKACIN SULFATE BICNU, CARMUSTINE CIDOFOVIR, CIDOFOVIR DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ETOMIDATE, ETOMIDATE FUROSEMIDE, FUROSEMIDE METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE ISETHIONATE, PENTAMIDINE ISETHIONATE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE TRANEXAMIC ACID, TRANEXAMIC ACID ZOLEDRONIC ACID, ZOLEDRONIC ACID EMD SERONO INC * EMD SERONO INC CETROTIDE, MAVENCLAD, TEPMETKO, HYDROCHLORIDE EMERALD INTL LTD * EMERALD INTERNATIONAL LTD , BACLOFEN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 70 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E ** EMERGENT * EMERGENT OPERATIONS IRELAND LTD NARCAN, NALOXONE HYDROCHLORIDE EMMAUS MEDCL * EMMAUS MEDICAL INC ENDARI, L- ENCUBE * ENCUBE ETHICALS PRIVATE LTD CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC) KETOCONAZOLE, KETOCONAZOLE TAVABOROLE, TAVABOROLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE ENCUBE ETHICALS * ENCUBE ETHICALS PVT LTD CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DESONIDE, DESONIDE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE PERMETHRIN, PERMETHRIN ENDO PHARM * ENDO PHARMACEUTICAL SOLUTIONS INC SUPPRELIN LA, ACETATE VALSTAR PRESERVATIVE FREE, VALRUBICIN VANTAS, HISTRELIN ACETATE ENDO PHARMS * ENDO PHARMACEUTICALS INC FORTESTA, TESTOSTERONE FROVA, FROVATRIPTAN SUCCINATE PERCODAN, ASPIRIN ENDO PHARMS INC * ENDO PHARMACEUTICALS INC AVEED, TESTOSTERONE UNDECANOATE COLY-MYCIN S, COLISTIN SULFATE MEGACE ES, MEGESTROL ACETATE NASCOBAL, CYANOCOBALAMIN VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE ENDO VENTURES * ENDO VENTURES LTD EPHEDRINE SULFATE, EPHEDRINE SULFATE EPI HLTH * EPI HEALTH LLC CLODERM, PIVALATE MINOLIRA, MINOCYCLINE HYDROCHLORIDE RHOFADE, HYDROCHLORIDE SITAVIG, ACYCLOVIR EPIC PHARMA * EPIC PHARMA INC MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE * EPIC PHARMA LLC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE SULINDAC, SULINDAC TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL EPIC PHARMA INC * EPIC PHARMA INC ESTRADIOL, ESTRADIOL SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE EPIC PHARMA LLC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 71 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E ** * EPIC PHARMA LLC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AMPHETAMINE SULFATE, AMPHETAMINE SULFATE AZITHROMYCIN, AZITHROMYCIN BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE, GLYBURIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE NYSTATIN, NYSTATIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PHENYTOIN, PHENYTOIN POTASSIUM CHLORIDE, POTASSIUM CHLORIDE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE EPIZYME INC * EPIZYME INC TAZVERIK, TAZEMETOSTAT HYDROBROMIDE ESPERION THERAPS INC * ESPERION THERAPEUTICS INC NEXLETOL, BEMPEDOIC ACID NEXLIZET, BEMPEDOIC ACID ESPERO * ESPERO BIOPHARMA INC DURLAZA, ASPIRIN ESSENTIAL ISOTOPES * ESSENTIAL ISOTOPES LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 ETHYPHARM * ETHYPHARM BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE * ETHYPHARM SA ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ETHYPHARM USA CORP * ETHYPHARM USA CORP BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE ETON * ETON PHARMACEUTICALS INC ALKINDI SPRINKLE, HYDROCORTISONE REZIPRES, EPHEDRINE HYDROCHLORIDE ETON PHARMS * ETON PHARMACEUTICALS BIORPHEN, PHENYLEPHRINE HYDROCHLORIDE EUGIA PHARMA * EUGIA PHARMA SPECIALITIES LTD ANASTROZOLE, ANASTROZOLE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 72 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E ** * EUGIA PHARMA SPECIALITIES LTD CAPECITABINE, CAPECITABINE CARBOPLATIN, CARBOPLATIN DOCETAXEL, DOCETAXEL HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE IMATINIB MESYLATE, IMATINIB MESYLATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LETROZOLE, LETROZOLE METHOTREXATE SODIUM, METHOTREXATE SODIUM OXALIPLATIN, OXALIPLATIN PROGESTERONE, PROGESTERONE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE EUROHLTH INTL SARL * EUROHEALTH INTERNATIONAL SARL AZACITIDINE, AZACITIDINE DROPERIDOL, DROPERIDOL HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE EVOFEM INC * EVOFEM INC PHEXXI, EVOKE PHARMA INC * EVOKE PHARMA INC GIMOTI, METOCLOPRAMIDE HYDROCHLORIDE EVUS * EVUS HEALTH SOLUTIONS LLC NITROMIST, NITROGLYCERIN EXALENZ BIOSCIENCE * EXALENZ BIOSCIENCE LTD IDKIT:HP, CITRIC ACID EXELA PHARMA * EXELA PHARMA SCIENCES LLC ACETYLCYSTEINE, ACETYLCYSTEINE AKOVAZ, EPHEDRINE SULFATE BLOXIVERZ, NEOSTIGMINE METHYLSULFATE CAFFEINE CITRATE, CAFFEINE CITRATE ELCYS, HYDROCHLORIDE ERYTHROMYCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATE GANZYK-RTU, GANCICLOVIR GLYRX-PF, GLYCOPYRROLATE MAGNESIUM SULFATE, MAGNESIUM SULFATE NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, SODIUM NITROPRUSSIDE , POTASSIUM ACETATE SODIUM BICARBONATE, SODIUM BICARBONATE TRANEXAMIC ACID, TRANEXAMIC ACID VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE , ZINC CHLORIDE EXELA PHARMA SCIENCE * EXELA PHARMA SCIENCES CAFFEINE CITRATE, CAFFEINE CITRATE NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE EXELIXIS * EXELIXIS INC COMETRIQ, S-MALATE EXELIXIS INC * EXELIXIS INC CABOMETYX, CABOZANTINIB S-MALATE EXELTIS USA INC * EXELTIS USA INC SLYND, DROSPIRENONE TYBLUME, ETHINYL ESTRADIOL EYEPOINT PHARMS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 73 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E ** * EYEPOINT PHARMACEUTICALS INC DEXYCU KIT, DEXAMETHASONE YUTIQ, FLUOCINOLONE ACETONIDE EYEVANCE * EYEVANCE PHARMACEUTICALS LLC FLAREX, NATACYN, TOBRADEX ST, DEXAMETHASONE ZERVIATE, CETIRIZINE HYDROCHLORIDE EYWA * EYWA PHARMA INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE VALPROIC ACID, VALPROIC ACID EYWA PHARMA * EYWA PHARMA PTE LTD ACETAZOLAMIDE, ACETAZOLAMIDE BACLOFEN, BACLOFEN URSODIOL, URSODIOL LILLY * ELI LILLY AND CO ALIMTA, PEMETREXED DISODIUM CIALIS, TADALAFIL CYMBALTA, DULOXETINE HYDROCHLORIDE EVISTA, RALOXIFENE HYDROCHLORIDE FORTEO, TERIPARATIDE GLUCAGON, GLUCAGON STRATTERA, ATOMOXETINE HYDROCHLORIDE SYMBYAX, FLUOXETINE HYDROCHLORIDE ZYPREXA ZYDIS, OLANZAPINE ZYPREXA, OLANZAPINE

** F ** FDC LTD * FDC LTD CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE LATANOPROST, LATANOPROST OFLOXACIN, OFLOXACIN OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) TIMOLOL MALEATE, TIMOLOL MALEATE FDN CONSUMER * FOUNDATION CONSUMER BRANDS LLC ALAVERT, LORATADINE (OTC) * FOUNDATION CONSUMER HEALTHCARE LLC PLAN B ONE-STEP, LEVONORGESTREL (OTC) FEINSTEIN * FEINSTEIN INSTITUTE MEDICAL RESEARCH AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 FERA PHARMS * FERA PHARMACEUTICALS LLC TOBRAMYCIN, TOBRAMYCIN FERA PHARMS LLC * FERA PHARMACEUTICALS LLC GENTAMICIN SULFATE, GENTAMICIN SULFATE FERRER INTERNACIONAL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 74 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F ** * FERRER INTERNACIONAL SA XEPI, OZENOXACIN FERRING * FERRING PHARMACEUTICALS INC ENDOMETRIN, PROGESTERONE FIRMAGON, ACETATE FERRING PHARMS INC * FERRING PHARMACEUTICALS INC CERVIDIL, DINOPROSTONE CLENPIQ, CITRIC ACID DDAVP, DESMOPRESSIN ACETATE NOCDURNA, DESMOPRESSIN ACETATE FLAMINGO PHARMS * FLAMINGO PHARMACEUTICALS LTD METRONIDAZOLE, METRONIDAZOLE PIROXICAM, PIROXICAM FLEXION THERAPS INC * FLEXION THERAPEUTICS INC ZILRETTA, TRIAMCINOLONE ACETONIDE FLORIDA * FLORIDA PHARMACEUTICAL PRODUCTS LLC LEVETIRACETAM, LEVETIRACETAM SUMATRIPTAN, SUMATRIPTAN FOLDRX PHARMS * FOLDRX PHARMACEUTICALS INC SUB INC VYNDAMAX, TAFAMIDIS VYNDAQEL, TAFAMIDIS MEGLUMINE FORESEE PHARMS * FORESEE PHARMACEUTICALS CO LTD CAMCEVI KIT, LEUPROLIDE MESYLATE FOREST LABS LLC * LLC NAMENDA XR, MEMANTINE HYDROCHLORIDE FOSUN PHARMA * FOSUN PHARMA USA INC CARISOPRODOL, CARISOPRODOL DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE LEFLUNOMIDE, LEFLUNOMIDE FOUGERA PHARMS * FOUGERA PHARMACEUTICALS INC ADAPALENE, ADAPALENE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE , AMCINONIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CUTIVATE, FLUTICASONE PROPIONATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE, HYDROCORTISONE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE LIDOCAINE AND PRILOCAINE, LIDOCAINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 75 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F ** * FOUGERA PHARMACEUTICALS INC METRONIDAZOLE, METRONIDAZOLE MOMETASONE FUROATE, MOMETASONE FUROATE , MUPIROCIN NYSTATIN, NYSTATIN OXISTAT, OXICONAZOLE NITRATE , PREDNICARBATE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM , TERCONAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE FOUGERA PHARMS INC * FOUGERA PHARMACEUTICALS INC ACYCLOVIR, ACYCLOVIR BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE, HYDROCORTISONE LIDOCAINE, LIDOCAINE NITROGLYCERIN, NITROGLYCERIN NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN TACROLIMUS, TACROLIMUS TERCONAZOLE, TERCONAZOLE FRESENIUS * FRESENIUS KABI DEUTSCHLAND GMBH INTRALIPID 10%, SOYBEAN OIL INTRALIPID 20%, SOYBEAN OIL INTRALIPID 30%, SOYBEAN OIL * FRESENIUS KABI IPSUM SRL NAFCILLIN SODIUM, NAFCILLIN SODIUM FRESENIUS KABI * FRESENIUS KABI ANTI INFECTIVES SRL PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM * FRESENIUS KABI AUSTRIA GMBH LACTULOSE, LACTULOSE FRESENIUS KABI USA * FRESENIUS KABI USA LLC ACETAMINOPHEN, ACETAMINOPHEN ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ADENOSINE, ADENOSINE AMIKACIN SULFATE, AMIKACIN SULFATE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE ARGATROBAN, ARGATROBAN ARSENIC TRIOXIDE, ARSENIC TRIOXIDE ATROPINE SULFATE, ATROPINE SULFATE AZITHROMYCIN, AZITHROMYCIN AZTREONAM, AZTREONAM BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BIVALIRUDIN, BIVALIRUDIN BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BORTEZOMIB, BORTEZOMIB CAFFEINE CITRATE, CAFFEINE CITRATE , CALCIUM GLUCONATE CARBOPLATIN, CARBOPLATIN ACETATE, CASPOFUNGIN ACETATE CEFOTETAN, CEFOTETAN DISODIUM SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 76 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F ** * FRESENIUS KABI USA LLC CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CISPLATIN, CISPLATIN CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM CYTARABINE, CYTARABINE , DACARBAZINE DAPTOMYCIN, DAPTOMYCIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE MESYLATE, DEFEROXAMINE MESYLATE DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.225%, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILAUDID, HYDROMORPHONE HYDROCHLORIDE , DIMENHYDRINATE DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE DIPRIVAN, PROPOFOL DIPYRIDAMOLE, DIPYRIDAMOLE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXY 100, DOXYCYCLINE HYCLATE DOXY 200, DOXYCYCLINE HYCLATE EPHEDRINE SULFATE, EPHEDRINE SULFATE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FENTANYL CITRATE, FENTANYL CITRATE , FLOXURIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUMAZENIL, FLUMAZENIL FLUOROURACIL, FLUOROURACIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE FOLIC ACID, FOLIC ACID FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FOSCARNET SODIUM, FOSCARNET SODIUM SODIUM, FOSPHENYTOIN SODIUM FULVESTRANT, FULVESTRANT FUROSEMIDE, FUROSEMIDE GANCICLOVIR SODIUM, GANCICLOVIR SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE GLUCAGON, GLUCAGON HYDROCHLORIDE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE , HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 77 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F ** * FRESENIUS KABI USA LLC HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE ICATIBANT ACETATE, ICATIBANT ACETATE HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE INDOMETHACIN, INDOMETHACIN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LINEZOLID, LINEZOLID MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE, MAGNESIUM SULFATE MANNITOL 25%, MANNITOL MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MESNA, MESNA METHOCARBAMOL, METHOCARBAMOL METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MICAFUNGIN SODIUM, MICAFUNGIN SODIUM MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NAROPIN, ROPIVACAINE HYDROCHLORIDE NEBUPENT, PENTAMIDINE ISETHIONATE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OMEGAVEN, FISH OIL ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXACILLIN SODIUM, OXACILLIN SODIUM OXALIPLATIN, OXALIPLATIN , OXYTOCIN PACLITAXEL, PACLITAXEL PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PENTAM, PENTAMIDINE ISETHIONATE PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM POLOCAINE, MEPIVACAINE HYDROCHLORIDE POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE POLYMYXIN B SULFATE, POLYMYXIN B SULFATE POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 78 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F ** * FRESENIUS KABI USA LLC POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE POTASSIUM CHLORIDE 20MEQ, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE SULFATE, PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE RIFAMPIN, RIFAMPIN ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SENSORCAINE, BUPIVACAINE HYDROCHLORIDE SENSORCAINE, BUPIVACAINE HYDROCHLORIDE SMOFLIPID 20%, FISH OIL , SODIUM ACETATE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 14.6%, SODIUM CHLORIDE SODIUM CHLORIDE 23.4%, SODIUM CHLORIDE SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBUTALINE SULFATE, TERBUTALINE SULFATE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE TIGECYCLINE, TIGECYCLINE TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID VALPROATE SODIUM, VALPROATE SODIUM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VIBISONE, CYANOCOBALAMIN SULFATE, VINBLASTINE SULFATE XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE XYLOCAINE, LIDOCAINE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID FRESENIUS MEDCL * FRESENIUS MEDICAL CARE NORTH AMERICA DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM PHOSLO GELCAPS, CALCIUM ACETATE PHOSLYRA, CALCIUM ACETATE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE FRONTIDA BIOPHARM * FRONTIDA BIOPHARM INC BISOPROLOL FUMARATE, BISOPROLOL FUMARATE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE OXAZEPAM, OXAZEPAM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 79 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** G1 THERAP * G1 THERAPEUTICS INC COSELA, DIHYDROCHLORIDE GALDERMA LABS * GALDERMA LABORATORIES INC CLOBEX, CLOBETASOL PROPIONATE EPIDUO FORTE, ADAPALENE GALDERMA LABS LP * GALDERMA LABORATORIES L P CLOBEX, CLOBETASOL PROPIONATE * GALDERMA LABORATORIES LP AKLIEF, CAPEX, FLUOCINOLONE ACETONIDE CLOBEX, CLOBETASOL PROPIONATE DESOWEN, DESONIDE DIFFERIN, ADAPALENE DIFFERIN, ADAPALENE (OTC) EPIDUO, ADAPALENE METROCREAM, METRONIDAZOLE METROGEL, METRONIDAZOLE METROLOTION, METRONIDAZOLE MIRVASO, BRIMONIDINE TARTRATE ORACEA, DOXYCYCLINE SOOLANTRA, IVERMECTIN TRI-LUMA, FLUOCINOLONE ACETONIDE VECTICAL, CALCITRIOL GALEN SPECIALTY * GALEN SPECIALTY PHARMA US LLC SYNERA, LIDOCAINE GALT PHARMS * GALT PHARMACEUTICALS LLC DORAL, ORAVIG, MICONAZOLE ORPHENGESIC FORTE, ASPIRIN GE HEALTHCARE * GE HEALTHCARE ADREVIEW, IOBENGUANE SULFATE I-123 CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT CLARISCAN, GADOTERATE MEGLUMINE INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT OMNIPAQUE 12, IOHEXOL OMNIPAQUE 140, IOHEXOL OMNIPAQUE 180, IOHEXOL OMNIPAQUE 240, IOHEXOL OMNIPAQUE 300, IOHEXOL OMNIPAQUE 350, IOHEXOL OMNIPAQUE 9, IOHEXOL OMNISCAN, GADODIAMIDE OPTISON, ALBUMIN HUMAN VISIPAQUE 270, IODIXANOL VISIPAQUE 320, IODIXANOL VIZAMYL, FLUTEMETAMOL F-18 GE HLTHCARE INC * GE HEALTHCARE INC DATSCAN, IOFLUPANE I-123 GENBIOPRO * GENBIOPRO INC MIFEPRISTONE, MIFEPRISTONE * GENENTECH INC ERIVEDGE, GENENTECH INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 80 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GENENTECH INC COTELLIC, FUMARATE ESBRIET, EVRYSDI, RISDIPLAM GAVRETO, ROZLYTREK, XOFLUZA, BALOXAVIR MARBOXIL GENERICS * GENERICS INTERNATIONAL VENTURES ENTERPRISES LLC DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE GENEYORK PHARMS * GENEYORK PHARMACEUTICALS GROUP LLC , PREDNISONE GENUS * GENUS LIFESCIENCES INC CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE FUMARATE, CLEMASTINE FUMARATE HYCODAN, HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN GENUS LIFESCIENCES * GENUS LIFE SCIENCES INC GOPRELTO, COCAINE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE * GENZYME CORP CLOLAR, CLOFARABINE MOZOBIL, PLERIXAFOR RENAGEL, SEVELAMER HYDROCHLORIDE RENVELA, SEVELAMER CARBONATE GENZYME CORP * GENZYME CORP CAPRELSA, CERDELGA, TARTRATE GILEAD * INC CAYSTON, AZTREONAM EMTRIVA, EMTRICITABINE HEPSERA, ADEFOVIR DIPIVOXIL LETAIRIS, AMBRISENTAN RANEXA, RANOLAZINE TRUVADA, EMTRICITABINE GILEAD SCIENCES * GILEAD SCIENCES LLC ATRIPLA, EFAVIRENZ GILEAD SCIENCES INC * GILEAD SCIENCES INC BIKTARVY, BICTEGRAVIR SODIUM COMPLERA, EMTRICITABINE DESCOVY, EMTRICITABINE EPCLUSA, SOFOSBUVIR GENVOYA, COBICISTAT HARVONI, LEDIPASVIR ODEFSEY, EMTRICITABINE SOVALDI, SOFOSBUVIR STRIBILD, COBICISTAT TYBOST, COBICISTAT VEKLURY, VEMLIDY, FUMARATE VIREAD, TENOFOVIR DISOPROXIL FUMARATE VOSEVI, SOFOSBUVIR ZYDELIG, GISKIT * GISKIT BV

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 81 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GISKIT BV EXEM FOAM KIT, AIR -TYPE A GLAND * GLAND PHARMA LTD CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE MEROPENEM, MEROPENEM MESNA, MESNA OXALIPLATIN, OXALIPLATIN TRANEXAMIC ACID, TRANEXAMIC ACID VECURONIUM BROMIDE, VECURONIUM BROMIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID GLAND PHARMA LTD * GLAND PHARMA LTD ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BIMATOPROST, BIMATOPROST BROMFENAC SODIUM, BROMFENAC SODIUM CALCITRIOL, CALCITRIOL CARBOPLATIN, CARBOPLATIN CISPLATIN, CISPLATIN CLOFARABINE, CLOFARABINE CYANOCOBALAMIN, CYANOCOBALAMIN CYTARABINE, CYTARABINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOCETAXEL, DOCETAXEL DOXERCALCIFEROL, DOXERCALCIFEROL DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE ERTAPENEM SODIUM, ERTAPENEM SODIUM ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM ETOMIDATE, ETOMIDATE FLUOROURACIL, FLUOROURACIL FOSCARNET SODIUM, FOSCARNET SODIUM FUROSEMIDE, FUROSEMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLYCOPYRROLATE, GLYCOPYRROLATE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LEVOFLOXACIN, LEVOFLOXACIN LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 82 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GLAND PHARMA LTD PACITAXEL, PACLITAXEL PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TEMSIROLIMUS, TEMSIROLIMUS THIOTEPA, THIOTEPA HYDROCHLORIDE, TIROFIBAN HYDROCHLORIDE TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOBRAMYCIN, TOBRAMYCIN VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZIPRASIDONE MESYLATE, ZIPRASIDONE MESYLATE ZOLEDRONIC ACID, ZOLEDRONIC ACID ZOLEDRONIC, ZOLEDRONIC ACID GLASSHOUSE PHARMS * GLASSHOUSE PHARMACEUTICALS LTD CANADA CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE OXCARBAZEPINE, OXCARBAZEPINE GLAUKOS * GLAUKOS CORP PHOTREXA VISCOUS IN 20%, RIBOFLAVIN 5'-PHOSPHATE SODIUM PHOTREXA, RIBOFLAVIN 5'-PHOSPHATE SODIUM GLAXO GRP ENGLAND * GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE INCRUSE ELLIPTA, GLAXO GRP LTD * GLAXO GROUP LTD DBA GLAXOSMITHKLINE FLOVENT HFA, FLUTICASONE PROPIONATE * GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE ADVAIR HFA, FLUTICASONE PROPIONATE BREO ELLIPTA, FLOVENT DISKUS 100, FLUTICASONE PROPIONATE FLOVENT DISKUS 250, FLUTICASONE PROPIONATE FLOVENT DISKUS 50, FLUTICASONE PROPIONATE GLAXOSMITHKLINE * GLAXOSMITHKLINE ABREVA, DOCOSANOL (OTC) AVODART, DUTASTERIDE BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE EPIVIR-HBV, LAMIVUDINE IMITREX STATDOSE, SUMATRIPTAN SUCCINATE IMITREX, SUMATRIPTAN IMITREX, SUMATRIPTAN SUCCINATE JALYN, DUTASTERIDE MALARONE PEDIATRIC, ATOVAQUONE MALARONE, ATOVAQUONE (MINT), NICOTINE POLACRILEX (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) RELENZA, VALTREX, VALACYCLOVIR HYDROCHLORIDE WELLBUTRIN SR, BUPROPION HYDROCHLORIDE * GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC) ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) ADVIL COLD AND SINUS, IBUPROFEN (OTC) ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 83 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC ADVIL DUAL ACTION WITH ACETAMINOPHEN, ACETAMINOPHEN (OTC) ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL LIQUI-GELS, IBUPROFEN (OTC) ADVIL MULTI-SYMPTOM COLD & FLU, CHLORPHENIRAMINE MALEATE (OTC) ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC) ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) ADVIL, IBUPROFEN (OTC) ADVIL, IBUPROFEN SODIUM (OTC) AXID AR, NIZATIDINE (OTC) CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC) CHILDREN'S ADVIL COLD, IBUPROFEN (OTC) CHILDREN'S ADVIL, IBUPROFEN (OTC) CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC) INFANT'S ADVIL, IBUPROFEN (OTC) JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC) LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) * GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND ANORO ELLIPTA, UMECLIDINIUM BROMIDE ARNUITY ELLIPTA, FLUTICASONE FUROATE KRINTAFEL, TAFENOQUINE SUCCINATE TRELEGY ELLIPTA, FLUTICASONE FUROATE * GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND SEREVENT, XINAFOATE VENTOLIN HFA, ALBUTEROL SULFATE * GLAXOSMITHKLINE LLC ZEJULA, TOSYLATE GLAXOSMITHKLINE CONS * GLAXOSMITHKLINE CONSUMER HEALTHCARE ALLI, ORLISTAT (OTC) EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC) FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC) FLONASE SENSIMIST ALLERGY RELIEF, FLUTICASONE FUROATE (OTC) LAMISIL AT, TERBINAFINE (OTC) LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC) NICORETTE, NICOTINE POLACRILEX (OTC) VOLTAREN ARTHRITIS , DICLOFENAC SODIUM (OTC) GLAXOSMITHKLINE LLC * GLAXOSMITHKLINE LLC AMERGE, HYDROCHLORIDE FLOLAN, EPOPROSTENOL SODIUM LAMICTAL CD, LAMOTRIGINE LAMICTAL ODT, LAMOTRIGINE LAMICTAL XR, LAMOTRIGINE LAMICTAL, LAMOTRIGINE MEPRON, ATOVAQUONE REQUIP, ROPINIROLE HYDROCHLORIDE RYTHMOL SR, PROPAFENONE HYDROCHLORIDE GLENMARK GENERICS * GLENMARK GENERICS INC USA ADAPALENE, ADAPALENE (OTC) BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE IMIQUIMOD, IMIQUIMOD MOMETASONE FUROATE, MOMETASONE FUROATE NIZATIDINE, NIZATIDINE ZONISAMIDE, ZONISAMIDE * GLENMARK GENERICS LIMITED BRIELLYN, ETHINYL ESTRADIOL FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE * GLENMARK GENERICS LTD ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE ALYACEN 1/35, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 84 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GLENMARK GENERICS LTD ALYACEN 7/7/7, ETHINYL ESTRADIOL ASHLYNA, ETHINYL ESTRADIOL ATOVAQUONE AND HYDROCHLORIDE, ATOVAQUONE CARVEDILOL, CARVEDILOL CICLOPIROX, CICLOPIROX CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DESOXIMETASONE, DESOXIMETASONE ESZOPICLONE, ESZOPICLONE FELODIPINE, FELODIPINE FLUCONAZOLE, FLUCONAZOLE FLUOCINONIDE, FLUOCINONIDE HEATHER, NORETHINDRONE HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE LAMOTRIGINE, LAMOTRIGINE LEVOFLOXACIN, LEVOFLOXACIN LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LITHIUM CARBONATE, LITHIUM CARBONATE MARLISSA, ETHINYL ESTRADIOL MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MOMETASONE FUROATE, MOMETASONE FUROATE MONTELUKAST SODIUM, MONTELUKAST SODIUM NAPROXEN, NAPROXEN NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ONDANSETRON, ONDANSETRON PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE TOPIRAMATE, TOPIRAMATE TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL TROSPIUM CHLORIDE, TROSPIUM CHLORIDE URSODIOL, URSODIOL VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VIORELE, DESOGESTREL ZOLMITRIPTAN, ZOLMITRIPTAN * GLENMARK GENERICS LTD INDOMETHACIN, INDOMETHACIN NORETHINDRONE ACETATE, NORETHINDRONE ACETATE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK PHARMS * INC TERIFLUNOMIDE, TERIFLUNOMIDE * GLENMARK PHARMACEUTICALS INC USA CICLOPIROX, CICLOPIROX CLOTRIMAZOLE, CLOTRIMAZOLE MUPIROCIN, MUPIROCIN * GLENMARK PHARMACEUTICALS LTD MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE * GLENMARK PHARMACEUTICALS SA ABIRATERONE ACETATE, ABIRATERONE ACETATE ATOVAQUONE, ATOVAQUONE AZELAIC ACID, AZELAIC ACID CALCIPOTRIENE, CALCIPOTRIENE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 85 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GLENMARK PHARMACEUTICALS SA DESONIDE, DESONIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM HAILEY 1.5/30, ETHINYL ESTRADIOL HAILEY FE 1.5/30, ETHINYL ESTRADIOL LINEZOLID, LINEZOLID NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE GLENMARK PHARMS INC * GLENMARK PHARMACEUTICALS INC USA CALCIPOTRIENE, CALCIPOTRIENE FULVESTRANT, FULVESTRANT LITHIUM CARBONATE, LITHIUM CARBONATE MUPIROCIN, MUPIROCIN CALCIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE GLENMARK PHARMS LTD * GLENMARK PHARMACEUTICALS LTD ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CHLORZOXAZONE, CHLORZOXAZONE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESONIDE, DESONIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ESTRADIOL, ESTRADIOL EZETIMIBE AND SIMVASTATIN, EZETIMIBE EZETIMIBE, EZETIMIBE FENOFIBRATE (MICRONIZED), FENOFIBRATE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE FLUCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE GABAPENTIN, GABAPENTIN HAILEY FE 1/20, ETHINYL ESTRADIOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE ICATIBANT ACETATE, ICATIBANT ACETATE INDOMETHACIN, INDOMETHACIN LAMOTRIGINE, LAMOTRIGINE LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL (OTC) LIDOCAINE, LIDOCAINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OXCARBAZEPINE, OXCARBAZEPINE PIMECROLIMUS, PIMECROLIMUS POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RANOLAZINE, RANOLAZINE RILUZOLE, RILUZOLE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 86 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GLENMARK PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE RUFINAMIDE, RUFINAMIDE SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE SIROLIMUS, SIROLIMUS TACROLIMUS, TACROLIMUS TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN THEOPHYLLINE, THEOPHYLLINE TOPIRAMATE, TOPIRAMATE TRETINOIN, TRETINOIN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE VORICONAZOLE, VORICONAZOLE GLENMARK PHARMS SA * GLENMARK PHARMACEUTICALS SA ACYCLOVIR, ACYCLOVIR , APREPITANT ASPIRIN AND DIPYRIDAMOLE, ASPIRIN NITROGLYCERIN, NITROGLYCERIN GLOBAL BLOOD THERAPS * GLOBAL BLOOD THERAPEUTICS INC OXBRYTA, VOXELOTOR GLW * GLW PHARMA GMBH OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS GRANULES * GRANULES INDIA LTD ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) GABAPENTIN, GABAPENTIN GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN, NAPROXEN POTASSIUM CHLORIDE, POTASSIUM CHLORIDE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE ZONISAMIDE, ZONISAMIDE * GRANULES PHARMACEUTICALS INC AMPHETAMINE SULFATE, AMPHETAMINE SULFATE BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN COLCHICINE, COLCHICINE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE PENICILLAMINE, PENICILLAMINE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE RAMELTEON, RAMELTEON TROSPIUM CHLORIDE, TROSPIUM CHLORIDE VIGABATRIN, VIGABATRIN GRANULES INDIA * GRANULES INDIA LTD IBUPROFEN, IBUPROFEN (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) GRAVITI PHARMS * GRAVITI PHARMACEUTICALS INC GABAPENTIN, GABAPENTIN * GRAVITI PHARMACEUTICALS PRIVATE LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 87 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G ** * GRAVITI PHARMACEUTICALS PRIVATE LTD ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM FENOFIBRATE, FENOFIBRATE FENOFIBRIC ACID, CHOLINE FENOFIBRATE RANOLAZINE, RANOLAZINE GUARDIAN DRUG * GUARDIAN DRUG CO GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE GUERBET * GUERBET LLC DOTAREM, GADOTERATE MEGLUMINE LIPIODOL, ETHIODIZED OIL GW RES LTD * GW RESEARCH LTD EPIDIOLEX,

** H ** HAEMONETICS * HAEMONETICS CORP SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE HAINAN POLY PHARM * HAINAN POLY PHARMACEUTICAL CO LTD AZITHROMYCIN, AZITHROMYCIN BIVALIRUDIN, BIVALIRUDIN EPTIFIBATIDE, EPTIFIBATIDE GANCICLOVIR SODIUM, GANCICLOVIR SODIUM LEVETIRACETAM, LEVETIRACETAM SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE HALOCARBON PRODS * HALOCARBON PRODUCTS CORP ISOFLURANE, ISOFLURANE SEVOFLURANE, SEVOFLURANE HANGZHOU BINJIANG * HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD ALENDRONATE SODIUM, ALENDRONATE SODIUM HANGZHOU ZHONGMEI * HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD ACARBOSE, ACARBOSE HARMONY * HARMONY BIOSCIENCES LLC WAKIX, HYDROCHLORIDE HARRIS PHARM * HARRIS PHARMACEUTICAL INC TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE HAVIX * HAVIX GROUP INC DBA AAVIS PHARMACEUTICALS AMPHETAMINE SULFATE, AMPHETAMINE SULFATE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE KETOCONAZOLE, KETOCONAZOLE HBT LABS INC * HBT LABS INC FULVESTRANT, FULVESTRANT HEC PHARM * HEC PHARM USA INC CLARITHROMYCIN, CLARITHROMYCIN LEVOFLOXACIN, LEVOFLOXACIN PRASUGREL, PRASUGREL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 88 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** HELSINN * HELSINN BIREX PHARMACEUTICALS LTD VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE HELSINN HLTHCARE * HELSINN HEALTHCARE SA AKYNZEO, FOSNETUPITANT CHLORIDE HYDROCHLORIDE AKYNZEO, HERCON PHARM * HERCON PHARMACEUTICAL LLC NITROGLYCERIN, NITROGLYCERIN HERITAGE LIFE * HERITAGE LIFE SCIENCES BARBADOS INC CLOZARIL, CLOZAPINE HERITAGE PHARMA * HERITAGE PHARMA LABS INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAZOLAMIDE, ACETAZOLAMIDE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE BUMETANIDE, BUMETANIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DIFLUNISAL, DIFLUNISAL DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENALAPRIL MALEATE, ENALAPRIL MALEATE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE METHIMAZOLE, METHIMAZOLE NADOLOL, NADOLOL NIFEDIPINE, NIFEDIPINE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE HERITAGE PHARMS INC * HERITAGE PHARMACEUTICALS INC ACYCLOVIR, ACYCLOVIR CALCIUM ACETATE, CALCIUM ACETATE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE ETHOSUXIMIDE, ETHOSUXIMIDE FELODIPINE, FELODIPINE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE GLYBURIDE, GLYBURIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE , KETOPROFEN LEFLUNOMIDE, LEFLUNOMIDE METRONIDAZOLE, METRONIDAZOLE NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NIMODIPINE, NIMODIPINE NYSTATIN, NYSTATIN SULFATE, PAROMOMYCIN SULFATE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE HERON THERAPS INC * HERON THERAPEUTICS INC CINVANTI, APREPITANT SUSTOL, GRANISETRON

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 89 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HERON THERAPEUTICS INC ZYNRELEF KIT, BUPIVACAINE HETERO LABS LTD * HETERO LABS LTD DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE HETERO LABS LTD III * HETERO LABS LTD UNIT III ABACAVIR SULFATE, ABACAVIR SULFATE ATOVAQUONE, ATOVAQUONE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOBAZAM, CLOBAZAM DABIGATRAN ETEXILATE MESYLATE, DABIGATRAN ETEXILATE MESYLATE DIMETHYL FUMARATE, DIMETHYL FUMARATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE EFAVIRENZ, EFAVIRENZ ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) FENOFIBRATE, FENOFIBRATE FINASTERIDE, FINASTERIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LANSOPRAZOLE, LANSOPRAZOLE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) LEVOCETIRIZINE HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LITHIUM CARBONATE, LITHIUM CARBONATE LOPINAVIR AND RITONAVIR, LOPINAVIR LORATADINE, LORATADINE (OTC) METHOCARBAMOL, METHOCARBAMOL METOPROLOL SUCCINATE, METOPROLOL SUCCINATE NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE NEVIRAPINE, NEVIRAPINE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) OMEPRAZOLE, OMEPRAZOLE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PREGABALIN, PREGABALIN RITONAVIR, RITONAVIR ROFLUMILAST, ROFLUMILAST RUFINAMIDE, RUFINAMIDE SIMVASTATIN, SIMVASTATIN TADALAFIL, TADALAFIL TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TORSEMIDE, TORSEMIDE ZIDOVUDINE, ZIDOVUDINE HETERO LABS LTD V * HETERO LABS LTD UNIT V ACYCLOVIR, ACYCLOVIR ARIPIPRAZOLE, ARIPIPRAZOLE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ENTECAVIR, ENTECAVIR FAMCICLOVIR, FAMCICLOVIR FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE IRBESARTAN, IRBESARTAN LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 90 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HETERO LABS LTD UNIT V LEVOFLOXACIN, LEVOFLOXACIN LINEZOLID, LINEZOLID LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MONTELUKAST SODIUM, MONTELUKAST SODIUM PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE SILODOSIN, SILODOSIN TELMISARTAN, TELMISARTAN TETRABENAZINE, TETRABENAZINE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE VALSARTAN, VALSARTAN HEYL CHEMISCH * HEYL CHEMISCH PHARMAZEUTISHE FABRIK RADIOGARDASE (), FERRIC HEXACYANOFERRATE(II) HIGH TECH PHARMA * HIGH TECHNOLOGY PHARMACAL CO INC VALPROIC ACID, VALPROIC ACID HIKAL * HIKAL LTD PREGABALIN, PREGABALIN HIKMA * HIKMA FARMACEUTICA LDA CEFOTAXIME, CEFOTAXIME SODIUM * HIKMA FARMACEUTICA PORTUGAL SA CEFOTETAN, CEFOTETAN DISODIUM CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM DOCETAXEL, DOCETAXEL ESTRADIOL VALERATE, ESTRADIOL VALERATE ETOMIDATE, ETOMIDATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE * HIKMA PHARMACEUTICALS AMOXICILLIN, AMOXICILLIN CEFACLOR, CEFACLOR CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEPHALEXIN, CEPHALEXIN CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE GLYBURIDE (MICRONIZED), GLYBURIDE * HIKMA PHARMACEUTICALS INTERNATIONAL LTD ATIVAN, LORAZEPAM CAFCIT, CAFFEINE CITRATE CODEINE SULFATE, CODEINE SULFATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DIGOXIN, DIGOXIN DOPRAM, DOXAPRAM HYDROCHLORIDE FUROSEMIDE, FUROSEMIDE HEPARIN SODIUM, HEPARIN SODIUM HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN DEXTROSE, LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE, LABETALOL HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE ROBAXIN, METHOCARBAMOL RUFINAMIDE, RUFINAMIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE * HIKMA PHARMACEUTICALS LLC ABIRATERONE ACETATE, ABIRATERONE ACETATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 91 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HIKMA PHARMACEUTICALS LLC AMOXICILLIN, AMOXICILLIN DANTROLENE SODIUM, DANTROLENE SODIUM DOXERCALCIFEROL, DOXERCALCIFEROL MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PIROXICAM, PIROXICAM * HIKMA PHARMACEUTICALS USA INC ACARBOSE, ACARBOSE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE ALPRAZOLAM, ALPRAZOLAM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM BEXAROTENE, BEXAROTENE BOSENTAN, BOSENTAN BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CALCITRIOL, CALCITRIOL CALCIUM ACETATE, CALCIUM ACETATE CAPECITABINE, CAPECITABINE CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE CILOSTAZOL, CILOSTAZOL CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOBAZAM, CLOBAZAM CLOTRIMAZOLE, CLOTRIMAZOLE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DALFAMPRIDINE, DALFAMPRIDINE DEFERIPRONE, DEFERIPRONE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DEXAMETHASONE INTENSOL, DEXAMETHASONE DEXAMETHASONE, DEXAMETHASONE DIAZEPAM INTENSOL, DIAZEPAM DIAZEPAM, DIAZEPAM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DISULFIRAM, DISULFIRAM DROXIDOPA, DROXIDOPA DURAMORPH PF, MORPHINE SULFATE EPHEDRINE SULFATE, EPHEDRINE SULFATE ETHACRYNIC ACID, ETHACRYNIC ACID EVEROLIMUS, EVEROLIMUS EXEMESTANE, EXEMESTANE FEBUXOSTAT, FEBUXOSTAT FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUCYTOSINE, FLUCYTOSINE FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC) FUROSEMIDE, FUROSEMIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE ICOSAPENT ETHYL, ICOSAPENT ETHYL IMATINIB MESYLATE, IMATINIB MESYLATE PAMOATE, IMIPRAMINE PAMOATE INFUMORPH, MORPHINE SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KLOXXADO, NALOXONE HYDROCHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOMILNACIPRAN HYDROCHLORIDE, LEVOMILNACIPRAN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 92 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HIKMA PHARMACEUTICALS USA INC LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE LINEZOLID, LINEZOLID LITHIUM CARBONATE, LITHIUM CARBONATE LITHIUM CITRATE, LITHIUM CITRATE LORAZEPAM INTENSOL, LORAZEPAM MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM MORPHINE SULFATE, MORPHINE SULFATE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NAPROXEN, NAPROXEN NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE PREDNISONE INTENSOL, PREDNISONE PREDNISONE, PREDNISONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RAMIPRIL, RAMIPRIL RISPERIDONE, RISPERIDONE RITONAVIR, RITONAVIR ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE RUFINAMIDE, RUFINAMIDE TETRABENAZINE, TETRABENAZINE TINIDAZOLE, TINIDAZOLE TORSEMIDE, TORSEMIDE , TRIAZOLAM ZALEPLON, ZALEPLON HIKMA FARMACEUTICA * HIKMA FARMACEUTICA (PORTUGAL) SA AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CEFOXITIN, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE ENALAPRILAT, ENALAPRILAT FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN METOPROLOL TARTRATE, METOPROLOL TARTRATE MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROGESTERONE, PROGESTERONE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 93 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HIKMA FARMACEUTICA (PORTUGAL) SA TERBUTALINE SULFATE, TERBUTALINE SULFATE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE VALPROATE SODIUM, VALPROATE SODIUM * HIKMA FARMACEUTICA PORTUGAL LDA CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE * HIKMA FARMACEUTICA PORTUGAL SA DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE OXYTOCIN, OXYTOCIN TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE * HIKMA FARMACEUTICA SA ZOLEDRONIC ACID, ZOLEDRONIC ACID HIKMA INTL PHARMS * HIKMA INTERNATIONAL PHARMACEUTICALS LLC CAPTOPRIL, CAPTOPRIL ACETATE, DIGOXIN, DIGOXIN DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE MITIGARE, COLCHICINE HIKMA PHARM CO LTD * HIKMA PHARM CO LTD ARGATROBAN, ARGATROBAN HIKMA PHARMS * HIKMA PHARMACEUTICALS AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM RIFAMPIN, RIFAMPIN VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE * HIKMA PHARMACEUTICALS CO LTD PARICALCITOL, PARICALCITOL HILL DERMAC * HILL DERMACEUTICALS INC DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE DERMOTIC, FLUOCINOLONE ACETONIDE HILL DERMACEUTICALS * HILL DERMACEUTICALS INC TOLAK, FLUOROURACIL HISAMITSU * HISAMITSU PHARMACEUTICAL CO INC SECUADO, ASENAPINE HISAMITSU PHARM CO * HISAMITSU PHARMACEUTICAL CO INC SALONPAS, (OTC) HISUN PHARM HANGZHOU * HISUN PHARMACEUTICAL (HANGZHOU) CO LTD CLADRIBINE, CLADRIBINE EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM OLANZAPINE, OLANZAPINE SIMVASTATIN, SIMVASTATIN * HISUN PHARMACEUTICAL HANGZHOU CO LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 94 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HISUN PHARMACEUTICAL HANGZHOU CO LTD DACTINOMYCIN, DACTINOMYCIN DAPTOMYCIN, DAPTOMYCIN DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE TICAGRELOR, TICAGRELOR HLTHCARE * HEALTHCARE PHARMACEUTICALS LTD ATENOLOL, ATENOLOL DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE HOFFMANN LA ROCHE * HOFFMANN LA ROCHE INC BONIVA, IBANDRONATE SODIUM VALCYTE, VALGANCICLOVIR HYDROCHLORIDE XELODA, CAPECITABINE ZELBORAF, HOFFMANN-LA ROCHE * HOFFMANN-LA ROCHE INC ALECENSA, HYDROCHLORIDE INVIRASE, MESYLATE * HONG KONG KING FRIEND INDUSTRIAL CO LTD BIVALIRUDIN, BIVALIRUDIN CYTARABINE, CYTARABINE DAPTOMYCIN, DAPTOMYCIN DECITABINE, DECITABINE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOCETAXEL, DOCETAXEL GLYCOPYRROLATE, GLYCOPYRROLATE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE TIGECYCLINE, TIGECYCLINE HOPE PHARMS * HOPE PHARMACEUTICALS NITHIODOTE, SODIUM , SODIUM NITRITE SODIUM , HORIZON * HORIZON MEDICINES LLC DUEXIS, FAMOTIDINE VIMOVO, ESOMEPRAZOLE MAGNESIUM * IRELAND DAC PENNSAID, DICLOFENAC SODIUM * HORIZON THERAPEUTICS USA INC PROCYSBI, BITARTRATE RAYOS, PREDNISONE HORIZON PHARMA USA * HORIZON PHARMA USA INC PROCYSBI, CYSTEAMINE BITARTRATE HORIZON THERAP * HORIZON THERAPEUTICS LLC BUPHENYL, RAVICTI, PHENYLBUTYRATE * HOSPIRA INC ACETYLCYSTEINE, ACETYLCYSTEINE ALFENTANIL, ALFENTANIL HYDROCHLORIDE AMIDATE, ETOMIDATE AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID , AMINOPHYLLINE CHLORIDE IN PLASTIC CONTAINER, ATROPINE SULFATE, ATROPINE SULFATE AZITHROMYCIN, AZITHROMYCIN BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 95 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HOSPIRA INC BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE CARBOCAINE, MEPIVACAINE HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN CIPROFLOXACIN, CIPROFLOXACIN CORLOPAM, FENOLDOPAM MESYLATE CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEMEROL, MEPERIDINE HYDROCHLORIDE DEXTROSE 25%, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50%, DEXTROSE DIAZEPAM, DIAZEPAM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE DROPERIDOL, DROPERIDOL ENALAPRILAT, ENALAPRILAT ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE FENTANYL CITRATE, FENTANYL CITRATE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FUROSEMIDE, FUROSEMIDE GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEVOPHED, NOREPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LORAZEPAM, LORAZEPAM M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID M.V.I. ADULT, ASCORBIC ACID M.V.I. PEDIATRIC, ASCORBIC ACID MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 96 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HOSPIRA INC MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE, MAGNESIUM SULFATE MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE MANNITOL 25%, MANNITOL MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE MARCAINE, BUPIVACAINE HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MORPHINE SULFATE, MORPHINE SULFATE NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE POTASSIUM ACETATE, POTASSIUM ACETATE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE PROPOFOL, PROPOFOL QUELICIN, SUCCINYLCHOLINE CHLORIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE SODIUM ACETATE, SODIUM ACETATE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 14.6%, SODIUM CHLORIDE SODIUM CHLORIDE 23.4%, SODIUM CHLORIDE SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION SUFENTANIL CITRATE, SUFENTANIL CITRATE TAZICEF, CEFTAZIDIME THAM, TROMETHAMINE TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VITAMIN K1, PHYTONADIONE ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE * HOSPIRA WORLDWIDE, INC FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NITROPRESS, SODIUM NITROPRUSSIDE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE HOSPIRA INC * HOSPIRA INC ADENOSINE, ADENOSINE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ARGATROBAN, ARGATROBAN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 97 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** * HOSPIRA INC ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE BIVALIRUDIN, BIVALIRUDIN BUSULFAN, BUSULFAN CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE DAPTOMYCIN, DAPTOMYCIN DOCETAXEL, DOCETAXEL DOXERCALCIFEROL, DOXERCALCIFEROL EPINEPHRINE (COPACKAGED), EPINEPHRINE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE HEPARIN SODIUM, HEPARIN SODIUM HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE INDOMETHACIN SODIUM, INDOMETHACIN SODIUM LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID LINEZOLID, LINEZOLID MAGNESIUM SULFATE, MAGNESIUM SULFATE MAXIPIME, CEFEPIME HYDROCHLORIDE MILRINONE LACTATE, MILRINONE LACTATE MORPHINE SULFATE, MORPHINE SULFATE NIPENT, PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PARICALCITOL, PARICALCITOL SODIUM BICARBONATE, SODIUM BICARBONATE TACROLIMUS, TACROLIMUS TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID HOSPIRA WORLDWIDE * HOSPIRA WORLDWIDE PTY OXALIPLATIN, OXALIPLATIN HOT SHOTS NM LLC * HOT SHOTS NUCLEAR LLC FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 HQ SPCLT PHARMA * HQ SPECIALTY PHARMA CORP CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE CISPLATIN, CISPLATIN DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE IMIPENEM AND CILASTATIN, CILASTATIN SODIUM LINEZOLID, LINEZOLID MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MEROPENEM, MEROPENEM HQ SPECIALITY PHARMA * HQ SPECIALITY PHARMA LLC LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM HQ SPECLT PHARMA * HQ SPECIALTY PHARMA CORP AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM HRA PHARMA * HRA PHARMA RARE DISEASES LYSODREN, METOPIRONE, HUMANWELL PURACAP * HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD DUTASTERIDE, DUTASTERIDE IBUPROFEN, IBUPROFEN (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 98 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H ** HUONS * HUONS CO LTD BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ROCHE * HOFFMANN LA ROCHE INC FUZEON, ENFUVIRTIDE KLONOPIN, CLONAZEPAM TAMIFLU, OSELTAMIVIR PHOSPHATE VALIUM, DIAZEPAM SHUANGCHENG * HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD BIVALIRUDIN, BIVALIRUDIN PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PREGABALIN, PREGABALIN

** I ** I3 PHARMS * I3 PHARMACEUTICALS LLC CHLORZOXAZONE, CHLORZOXAZONE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE RAMELTEON, RAMELTEON IBSA INST BIO * IBSA INSTITUT BIOCHIMIQUE SA LICART, DICLOFENAC EPOLAMINE ICHNOS * ICHNOS SCIENCES SA DEFERASIROX, DEFERASIROX ICU MEDICAL INC * ICU MEDICAL INC ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS AMINOSYN-PF 10%, AMINO ACIDS AMINOSYN-PF 7%, AMINO ACIDS DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 99 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * ICU MEDICAL INC POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION IDENTIRX * IDENTIRX LLC TAVABOROLE, TAVABOROLE IMPACT * IMPACT BIOMEDICINES INC A WHOLLY OWNED SUB OF CELGENE CORP INREBIC, HYDROCHLORIDE IMPAX * IMPAX LABORATORIES LLC ADRENACLICK, EPINEPHRINE BACLOFEN, BACLOFEN IMPAX LABS * IMPAX LABORATORIES INC ACARBOSE, ACARBOSE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE DANTROLENE SODIUM, DANTROLENE SODIUM DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DIGOXIN, DIGOXIN DIPYRIDAMOLE, DIPYRIDAMOLE FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE , METHYLTESTOSTERONE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NADOLOL AND , BENDROFLUMETHIAZIDE OMEPRAZOLE, OMEPRAZOLE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RILUZOLE, RILUZOLE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TERBUTALINE SULFATE, TERBUTALINE SULFATE IMPAX LABS INC * IMPAX LABORATORIES INC ACITRETIN, ACITRETIN ALBENZA, ALBENDAZOLE ALENDRONATE SODIUM, ALENDRONATE SODIUM BUDESONIDE, BUDESONIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE DEXEDRINE, DEXTROAMPHETAMINE SULFATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE EMVERM, EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 100 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * IMPAX LABORATORIES INC HYDROCORTISONE, HYDROCORTISONE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE LAMOTRIGINE, LAMOTRIGINE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLTESTOSTERONE, METHYLTESTOSTERONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RYTARY, CARBIDOPA IMPAX PHARMS * IMPAX PHARMACEUTICALS GEMFIBROZIL, GEMFIBROZIL MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE INCYTE CORP * INCYTE CORP JAKAFI, PHOSPHATE PEMAZYRE, INDCHEMIE HEALTH * INDCHEMIE HEALTH SPECIALTIES PVT LTD ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM INDICUS PHARMA * INDICUS PHARMA LLC ACETAZOLAMIDE, ACETAZOLAMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE LETROZOLE, LETROZOLE MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE INDIVIOR INC * INDIVIOR INC BUPRENEX, BUPRENORPHINE HYDROCHLORIDE PERSERIS KIT, RISPERIDONE SUBLOCADE, BUPRENORPHINE SUBOXONE, BUPRENORPHINE HYDROCHLORIDE INDOCO * INDOCO REMEDIES LTD ALLOPURINOL, ALLOPURINOL APIXABAN, APIXABAN BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE FEBUXOSTAT, FEBUXOSTAT OLANZAPINE, OLANZAPINE RASAGILINE MESYLATE, RASAGILINE MESYLATE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE INDOCO REMEDIES * INDOCO REMEDIES LTD GLIMEPIRIDE, GLIMEPIRIDE INFORLIFE * INFORLIFE SA CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE MIDAZOLAM IN 0.9% SODIUM CHLORIDE, MIDAZOLAM ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID INGENUS PHARMS LLC * INGENUS PHARMACEUTICALS LLC ARSENIC TRIOXIDE, ARSENIC TRIOXIDE , CABERGOLINE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DECITABINE, DECITABINE DOCETAXEL, DOCETAXEL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 101 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * INGENUS PHARMACEUTICALS LLC MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM ZOLEDRONIC ACID, ZOLEDRONIC ACID INGENUS PHARMS NJ * INGENUS PHARMACEUTICALS NJ LLC CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN INNOCOLL PHARMS * INNOCOLL PHARMACEUTICALS XARACOLL, BUPIVACAINE HYDROCHLORIDE INNOGENIX * INNOGENIX LLC BACLOFEN, BACLOFEN HALOPERIDOL, HALOPERIDOL LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE METOLAZONE, METOLAZONE METRONIDAZOLE, METRONIDAZOLE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE INNOPHARMA * INNOPHARMA LICENSING LLC A SUB OF PFIZER INC PROPOFOL, PROPOFOL INSMED INC * INSMED INC ARIKAYCE KIT, AMIKACIN SULFATE INST BIOCHEM * INSTITUT BIOCHEMIQUE SA FLECTOR, DICLOFENAC EPOLAMINE INSTITUT BIOCHIMIQUE * INSTITUT BIOCHIMIQUE SA (IBSA) TIROSINT, LEVOTHYROXINE SODIUM TIROSINT-SOL, LEVOTHYROXINE SODIUM INTAS PHARMS USA * INTAS PHARMACEUTICALS USA IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE INTELLIPHARMACEUTICS * INTELLIPHARMACEUTICS CORP DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE INTERCEPT PHARMS INC * INTERCEPT PHARMACEUTICALS INC OCALIVA, OBETICHOLIC ACID INTERPHARMA PRAHA AS * INTERPHARMA PRAHA AS ORALTAG, IOHEXOL INTERSECT ENT INC * INTERSECT ENT INC SINUVA, MOMETASONE FUROATE INTL ISOTOPES * INTERNATIONAL ISOTOPES INC SODIUM IODIDE I 131, SODIUM IODIDE I-131 INTL * INTERNATIONAL MEDICATION SYSTEM LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE PHYTONADIONE, PHYTONADIONE PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE INTL MEDICATION SYS * INTERNATIONAL MEDICATION SYSTEMS LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 102 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * INTERNATIONAL MEDICATION SYSTEMS LTD ATROPINE SULFATE, ATROPINE SULFATE CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE DEXTROSE 50%, DEXTROSE EPINEPHRINE, EPINEPHRINE LORAZEPAM, LORAZEPAM MORPHINE SULFATE, MORPHINE SULFATE SODIUM BICARBONATE, SODIUM BICARBONATE INTRA-CELLULAR * INTRA-CELLULAR THERAPIES INC CAPLYTA, TOSYLATE INVAGEN PHARMS * INVAGEN PHARMACEUTICALS INC ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM BENZTROPINE MESYLATE, BENZTROPINE MESYLATE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CALCIUM ACETATE, CALCIUM ACETATE CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FENOFIBRATE (MICRONIZED), FENOFIBRATE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GABAPENTIN, GABAPENTIN GEMFIBROZIL, GEMFIBROZIL GLIMEPIRIDE, GLIMEPIRIDE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL MEPROBAMATE, MEPROBAMATE NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAPROXEN, NAPROXEN OLANZAPINE, OLANZAPINE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PREGABALIN, PREGABALIN QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE VIGABATRIN, VIGABATRIN VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM ZOLMITRIPTAN, ZOLMITRIPTAN ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ZONISAMIDE, ZONISAMIDE INVATECH * INVATECH PHARMA SOLUTIONS LLC DIVALPROEX SODIUM, DIVALPROEX SODIUM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE INVENTIA * INVENTIA HEALTHCARE LTD COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 103 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * INVENTIA HEALTHCARE LTD DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE LANSOPRAZOLE, LANSOPRAZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PALIPERIDONE, PALIPERIDONE TELMISARTAN, TELMISARTAN INVENTIA HLTHCARE * INVENTIA HEALTHCARE PRIVATE LTD BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE IONETIX * IONETIX CORP AMMONIA N 13, AMMONIA N-13 IPCA LABS LTD * LTD ALLOPURINOL, ALLOPURINOL ATENOLOL, ATENOLOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) PHOSPHATE, CHLOROQUINE PHOSPHATE FUROSEMIDE, FUROSEMIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM IPR * IPR PHARMACEUTICALS INC CRESTOR, ROSUVASTATIN CALCIUM ZOMIG, ZOLMITRIPTAN IPSEN INC * IPSEN BIOPHARMACEUTICALS INC ONIVYDE, IRINOTECAN HYDROCHLORIDE IPSEN PHARMA * IPSEN PHARMA BIOTECH SAS SOMATULINE DEPOT, ACETATE IRONSHORE PHARMS * IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE ISOTEX * ISOTEX DIAGNOSTICS GLOFIL-125, IOTHALAMATE SODIUM I-125 ISTITUTO BIO ITA SPA * ISTITUTO BIOCHIMICO ITALIANO SPA AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM NAFCILLIN SODIUM, NAFCILLIN SODIUM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PIPERACILLIN, PIPERACILLIN SODIUM ITALFARMACO SPA * ITALFARMACO SPA TIGLUTIK KIT, RILUZOLE IVAX PHARMS * IVAX PHARMACEUTICALS INC VALSARTAN, VALSARTAN IVAX SUB TEVA PHARMS

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 104 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I ** * IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE BACLOFEN, BACLOFEN CABERGOLINE, CABERGOLINE CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CIMETIDINE, CIMETIDINE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOZAPINE, CLOZAPINE CYCLOSPORINE, CYCLOSPORINE DIAZEPAM, DIAZEPAM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM FAMOTIDINE, FAMOTIDINE FLUCONAZOLE, FLUCONAZOLE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

** J ** J AND J CONSUMER INC * JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC) CHILDREN'S MOTRIN, IBUPROFEN (OTC) CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC) IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC) JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC) MOTRIN IB, IBUPROFEN (OTC) PEPCID AC, FAMOTIDINE (OTC) PEPCID COMPLETE, CALCIUM CARBONATE (OTC) RHINOCORT ALLERGY, BUDESONIDE (OTC) SINE-AID IB, IBUPROFEN (OTC) SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) , ACETAMINOPHEN (OTC) ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC) JACOBUS * JACOBUS PHARMACEUTICAL CO DAPSONE, DAPSONE PASER, AMINOSALICYLIC ACID JACOBUS PHARM CO INC * JACOBUS PHARMACEUTICAL CO INC RUZURGI, AMIFAMPRIDINE * JANSSEN BIOTECH INC BALVERSA, ERLEADA, ZYTIGA, ABIRATERONE ACETATE JANSSEN PHARMS * INC CONCERTA, METHYLPHENIDATE HYDROCHLORIDE DITROPAN XL, OXYBUTYNIN CHLORIDE DURAGESIC-100, FENTANYL DURAGESIC-12, FENTANYL DURAGESIC-25, FENTANYL DURAGESIC-37, FENTANYL DURAGESIC-50, FENTANYL DURAGESIC-75, FENTANYL ELMIRON, SODIUM HALDOL, HALOPERIDOL DECANOATE INVEGA SUSTENNA, PALIPERIDONE PALMITATE INVEGA TRINZA, PALIPERIDONE PALMITATE INVEGA, PALIPERIDONE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 105 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J ** * JANSSEN PHARMACEUTICALS INC INVOKAMET XR, INVOKAMET, CANAGLIFLOZIN INVOKANA, CANAGLIFLOZIN PONVORY, PONESIMOD RAZADYNE ER, GALANTAMINE HYDROBROMIDE RISPERDAL CONSTA, RISPERIDONE RISPERDAL, RISPERIDONE SPORANOX, ITRACONAZOLE SPRAVATO, HYDROCHLORIDE TOPAMAX, TOPIRAMATE ULTRACET, ACETAMINOPHEN ULTRAM, TRAMADOL HYDROCHLORIDE XARELTO, JANSSEN PRODS * JANSSEN PRODUCTS LP EDURANT, HYDROCHLORIDE PREZCOBIX, COBICISTAT PREZISTA, SYMTUZA, COBICISTAT YONDELIS, JANSSEN R AND D * JANSSEN RESEARCH AND DEVELOPMENT LLC INTELENCE, ETRAVIRINE JANSSEN THERAP * JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP SIRTURO, FUMARATE JAZZ * IRELAND LTD SUNOSI, SOLRIAMFETOL HYDROCHLORIDE XYWAV, CALCIUM OXYBATE ZEPZELCA, LURBINECTEDIN JAZZ PHARMS * JAZZ PHARMACEUTICALS INC XYREM, JAZZ PHARMS INC * JAZZ PHARMACEUTICALS INC DEFITELIO, DEFIBROTIDE SODIUM JDP * JDP THERAPEUTICS LLC QUZYTTIR, CETIRIZINE HYDROCHLORIDE JIANGSU HANSOH PHARM * JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE ICATIBANT ACETATE, ICATIBANT ACETATE VINORELBINE TARTRATE, VINORELBINE TARTRATE JIANGSU HENGRUI MED * JIANGSU HENGRUI MEDICINE CO LTD CARMUSTINE, CARMUSTINE CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DAPTOMYCIN, DAPTOMYCIN DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOCETAXEL, DOCETAXEL FONDAPARINUX SODIUM, FONDAPARINUX SODIUM IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN THIOTEPA, THIOTEPA JIANGXI BOYA SEEHOT * JIANGXI BOYA SEEHOT PHARMACEUTICAL CO LTD SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE JOHNS HOPKINS UNIV

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 106 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J ** * JOHNS HOPKINS UNIV AMMONIA N 13, AMMONIA N-13 JOHNSON AND JOHNSON * JOHNSON AND JOHNSON CONSUMER INC L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC) VISINE, NAPHAZOLINE HYDROCHLORIDE (OTC) * JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES MEN'S ROGAINE, MINOXIDIL (OTC) ROGAINE (FOR MEN), MINOXIDIL (OTC) ROGAINE (FOR WOMEN), MINOXIDIL (OTC) ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) WOMEN'S ROGAINE, MINOXIDIL (OTC) JOURNEY * JOURNEY MEDICAL CORP EURAX, CROTAMITON EXELDERM, NITRATE QBREXZA, GLYCOPYRRONIUM TOSYLATE XIMINO, MINOCYCLINE HYDROCHLORIDE JUBILANT * JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA DRAX EXAMETAZIME, TECHNETIUM TC-99M EXAMETAZIME KIT DRAXIMAGE DTPA, TECHNETIUM TC-99M PENTETATE KIT DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE HICON, SODIUM IODIDE I-131 RUBY-FILL, RUBIDIUM CHLORIDE RB-82 SODIUM IODIDE I 131, SODIUM IODIDE I-131 JUBILANT CADISTA * JUBILANT CADISTA PHARMACEUTICALS INC CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LAMOTRIGINE, LAMOTRIGINE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE PREDNISONE, PREDNISONE PROCOMP, PROCHLORPERAZINE MALEATE TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE JUBILANT DRAXIMAGE * JUBILANT DRAXIMAGE RADIOPHARMACIES INC FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 * JUBILANT DRAXIMAGE USA INC TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT JUBILANT GENERICS * JUBILANT GENERICS LTD AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE IRBESARTAN, IRBESARTAN ITRACONAZOLE, ITRACONAZOLE OLANZAPINE, OLANZAPINE RISPERIDONE, RISPERIDONE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SPIRONOLACTONE, SPIRONOLACTONE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALSARTAN, VALSARTAN ZOLMITRIPTAN, ZOLMITRIPTAN STEVENS J * JEROME STEVENS PHARMACEUTICALS INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 107 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J ** * JEROME STEVENS PHARMACEUTICALS INC BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN DIGOXIN, DIGOXIN UNITHROID, LEVOTHYROXINE SODIUM **

** K ** GRIFFEN * KW GRIFFEN CO BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC) KAI PHARMS INC * KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC PARSABIV, ETELCALCETIDE KALA PHARMS INC * KALA PHARMACEUTICALS INC EYSUVIS, LOTEPREDNOL ETABONATE INVELTYS, LOTEPREDNOL ETABONATE KALEO INC * KALEO INC AUVI-Q, EPINEPHRINE KARTHA * KARTHA PHARMACEUTICALS INC BACLOFEN, BACLOFEN KARYOPHARM THERAPS * KARYOPHARM THERAPEUTICS INC XPOVIO, KENTON * KENTON CHEMICALS AND PHARMACEUTICALS CORP ACYCLOVIR, ACYCLOVIR ANASTROZOLE, ANASTROZOLE BICALUTAMIDE, BICALUTAMIDE GLYCOPYRROLATE, GLYCOPYRROLATE RILUZOLE, RILUZOLE KERYX BIOPHARMS * KERYX BIOPHARMACEUTICALS INC AURYXIA, FERRIC CITRATE KETTERING MEDCTR * KETTERING MEDCTR FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 KINDEVA * KINDEVA DRUG DELIVERY LP FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-50, FENTANYL FENTANYL-75, FENTANYL PROVENTIL-HFA, ALBUTEROL SULFATE KING PHARMS * INC SYNERCID, DALFOPRISTIN * KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC CYTOMEL, LIOTHYRONINE SODIUM LEVOXYL, LEVOTHYROXINE SODIUM ** * KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC SKELAXIN, METAXALONE KING PHARMS LLC * KING PHARMACEUTICALS LLC ALTACE, RAMIPRIL BICILLIN C-R 900/300, PENICILLIN G BENZATHINE BICILLIN C-R, PENICILLIN G BENZATHINE BICILLIN L-A, PENICILLIN G BENZATHINE CORZIDE, BENDROFLUMETHIAZIDE PENICILLIN G , PENICILLIN G PROCAINE SILVADENE, SILVER SULFADIAZINE TAPAZOLE, METHIMAZOLE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 108 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K ** KNIGHT THERAPS * KNIGHT THERAPEUTICS USA INC IMPAVIDO, KOWA CO * KOWA CO LTD LIVALO, PITAVASTATIN CALCIUM KRAMER * KRAMER LABORATORIES INC NIZORAL ANTI-DANDRUFF, KETOCONAZOLE (OTC) KREITCHMAN PET CTR * KREITCHMAN PET CENTER AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 KVK TECH * KVK TECH INC BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE KALEXATE, SODIUM POLYSTYRENE SULFONATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE KVK TECH INC * KVK TECH INC APADAZ, ACETAMINOPHEN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE KYOWA KIRIN * KYOWA KIRIN INC FARESTON, CITRATE NOURIANZ, SANCUSO, GRANISETRON KYTHERA BIOPHARMS * KYTHERA BIOPHARMACEUTICALS INC KYBELLA, DEOXYCHOLIC ACID

** L ** L CO * L PERRIGO CO CIMETIDINE, CIMETIDINE (OTC) CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC) LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVONORGESTREL, LEVONORGESTREL LEVONORGESTREL, LEVONORGESTREL (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MONTELUKAST SODIUM, MONTELUKAST SODIUM NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) LA JOLLA PHARMA * LA JOLLA PHARMA LLC GIAPREZA, ANGIOTENSIN II ACETATE LAB HRA PHARMA * LABORATOIRE HRA PHARMA ELLA, LABORATOIRE HRA * LABORATOIRE HRA PHARMA

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 109 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LABORATOIRE HRA PHARMA LEVONORGESTREL, LEVONORGESTREL (OTC) LABORATORIOS GRIFOLS * LABORATORIOS GRIFOLS SA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE LABORATORIOS SALVAT * LABORATORIOS SALVAT SA OTOVEL, CIPROFLOXACIN HYDROCHLORIDE LANDELA PHARM * LANDELA PHARMACEUTICAL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LANNETT * LANNETT CO INC ACETAZOLAMIDE, ACETAZOLAMIDE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE LANORINAL, ASPIRIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE PROBALAN, LANNETT CO INC * LANNETT CO INC ALBUTEROL SULFATE, ALBUTEROL SULFATE ARIPIPRAZOLE, ARIPIPRAZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM BACLOFEN, BACLOFEN BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOBAZAM, CLOBAZAM CODEINE SULFATE, CODEINE SULFATE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DANAZOL, DANAZOL DEXAMETHASONE, DEXAMETHASONE DIAZEPAM, DIAZEPAM DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE DRONABINOL, DRONABINOL ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC) HALOPERIDOL, HALOPERIDOL LACTATE HYDROCORTISONE, HYDROCORTISONE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LACTULOSE, LACTULOSE LAMIVUDINE, LAMIVUDINE LANSOPRAZOLE, LANSOPRAZOLE LANSOPRAZOLE, LANSOPRAZOLE (OTC) LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 110 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LANNETT CO INC LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LOPINAVIR AND RITONAVIR, LOPINAVIR LORATADINE, LORATADINE (OTC) LORAZEPAM, LORAZEPAM LOXAPINE SUCCINATE, LOXAPINE SUCCINATE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METADATE CD, METHYLPHENIDATE HYDROCHLORIDE METAPROTERENOL SULFATE, METAPROTERENOL SULFATE METAXALONE, METAXALONE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MONOKET, ISOSORBIDE MONONITRATE MONTELUKAST SODIUM, MONTELUKAST SODIUM NIACIN, NIACIN NYSTATIN, NYSTATIN OMEPRAZOLE, OMEPRAZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE, PREDNISOLONE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN RISPERIDONE, RISPERIDONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUMATRIPTAN, SUMATRIPTAN TERBUTALINE SULFATE, TERBUTALINE SULFATE THEOPHYLLINE, THEOPHYLLINE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE URSODIOL, URSODIOL VALPROIC ACID, VALPROIC ACID LANTHEUS MEDCL * LANTHEUS MEDICAL IMAGING INC CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT DEFINITY RT, PERFLUTREN DEFINITY, PERFLUTREN GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67 NEUROLITE, TECHNETIUM TC-99M BICISATE KIT TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201 XENON XE 133, XENON XE-133 LANTHEUS MEDICAL * LANTHEUS MEDICAL IMAGING INC QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM LARKEN LABS * LARKEN LABORATORIES INC DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE OFLOXACIN, OFLOXACIN LARKEN LABS INC * LARKEN LABORATORIES INC ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN ALLZITAL, ACETAMINOPHEN BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN DEXAMETHASONE, DEXAMETHASONE LAURUS LABS LTD * LAURUS LABS LTD ATAZANAVIR SULFATE, ATAZANAVIR SULFATE EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 111 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LAURUS LABS LTD METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE LAVIPHARM * LAVIPHARM SA CATAPRES-TTS-1, CLONIDINE CATAPRES-TTS-2, CLONIDINE CATAPRES-TTS-3, CLONIDINE LEADIANT BIOSCI INC * LEADIANT BIOSCIENCES INC ABELCET, AMPHOTERICIN B CARNITOR SF, LEVOCARNITINE CARNITOR, LEVOCARNITINE CYSTARAN, CYSTEAMINE HYDROCHLORIDE MATULANE, HYDROCHLORIDE LEADING PHARMA LLC * LEADING PHARMA LLC AMINOCAPROIC ACID, AMINOCAPROIC ACID BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE FOLIC ACID, FOLIC ACID FUROSEMIDE, FUROSEMIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYUREA, HYDROXYUREA IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LORAZEPAM, LORAZEPAM NIFEDIPINE, NIFEDIPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE LEO PHARMA AS * LEO PHARMA AS DOVONEX, CALCIPOTRIENE ENSTILAR, BETAMETHASONE DIPROPIONATE FINACEA, AZELAIC ACID PROTOPIC, TACROLIMUS TACLONEX, BETAMETHASONE DIPROPIONATE LG CHEM LTD * LG CHEM LTD FACTIVE, MESYLATE LGM PHARMA * LGM PHARMA SOLUTIONS LLC BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CHENODIOL, CHENODIOL GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCODONE BITARTRATE AND ASPIRIN, ASPIRIN HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE NABUMETONE, NABUMETONE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) URSODIOL, URSODIOL LIEBEL-FLARSHEIM * LIEBEL-FLARSHEIM CO LLC CONRAY, IOTHALAMATE MEGLUMINE CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE MD-GASTROVIEW, DIATRIZOATE MEGLUMINE OPTIRAY 240, IOVERSOL OPTIRAY 300, IOVERSOL OPTIRAY 320, IOVERSOL OPTIRAY 350, IOVERSOL SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE LIFE MOLECULAR

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 112 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LIFE MOLECULAR IMAGING SA NEURACEQ, FLORBETABEN F-18 LNK * LNK INTERNATIONAL INC DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LNK INTL INC * LNK INTERNATIONAL INC NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) LOREAL USA * LOREAL USA PRODUCTS INC ANTHELIOS 20, (OTC) ANTHELIOS 40, AVOBENZONE (OTC) ANTHELIOS SX, AVOBENZONE (OTC) CAPITAL SOLEIL 15, AVOBENZONE (OTC) LOTUS PHARM CO LTD * LOTUS PHARMACEUTICAL CO LTD LEVETIRACETAM, LEVETIRACETAM * LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT LEVETIRACETAM, LEVETIRACETAM METHOTREXATE SODIUM, METHOTREXATE SODIUM LOXO ONCOLOGY INC * LOXO ONCOLOGY INC RETEVMO, LUITPOLD * LUITPOLD PHARMACEUTICALS INC AMINOCAPROIC ACID, AMINOCAPROIC ACID LUKARE MEDICAL LLC * LUKARE MEDICAL LLC ELLIOTTS B , CALCIUM CHLORIDE LUNDBECK NA LTD * LUNDBECK NA LTD NORTHERA, DROXIDOPA LUNDBECK PHARMS LLC * LUNDBECK PHARMACEUTICALS LLC ONFI, CLOBAZAM SABRIL, VIGABATRIN LUPIN * LUPIN INC ALBUTEROL SULFATE, ALBUTEROL SULFATE ANTARA (MICRONIZED), FENOFIBRATE BUDESONIDE, BUDESONIDE DESOXIMETASONE, DESOXIMETASONE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ** MIBELAS 24 FE, ETHINYL ESTRADIOL NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NYSTATIN, NYSTATIN ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE QUINARETIC, HYDROCHLOROTHIAZIDE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SOLOSEC, SECNIDAZOLE TESTOSTERONE, TESTOSTERONE TOBRAMYCIN, TOBRAMYCIN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE * LUPIN LTD AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CARVEDILOL, CARVEDILOL CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 113 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LUPIN LTD CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN DIVALPROEX SODIUM, DIVALPROEX SODIUM ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOVASTATIN, LOVASTATIN QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RAMIPRIL, RAMIPRIL SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN TRANDOLAPRIL, TRANDOLAPRIL LUPIN ATLANTIS * LUPIN ATLANTIS HOLDINGS SA DIMETHYL FUMARATE, DIMETHYL FUMARATE LUPIN LTD * LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL * LUPIN LTD ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE AMABELZ, ESTRADIOL AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE ARMODAFINIL, ARMODAFINIL ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM ATOVAQUONE, ATOVAQUONE AZITHROMYCIN, AZITHROMYCIN BEKYREE, DESOGESTREL BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BIMATOPROST, BIMATOPROST BLISOVI 24 FE, ETHINYL ESTRADIOL BLISOVI FE 1.5/30, ETHINYL ESTRADIOL BLISOVI FE 1/20, ETHINYL ESTRADIOL BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CALCIUM ACETATE, CALCIUM ACETATE CELECOXIB, CELECOXIB CLOBAZAM, CLOBAZAM CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE DAYSEE, ETHINYL ESTRADIOL DECITABINE, DECITABINE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ENSKYCE, DESOGESTREL ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESZOPICLONE, ESZOPICLONE ETHACRYNIC ACID, ETHACRYNIC ACID FALLBACK SOLO, LEVONORGESTREL (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 114 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LUPIN LTD FAMOTIDINE, FAMOTIDINE FENOFIBRATE, FENOFIBRATE FENOFIBRIC ACID, CHOLINE FENOFIBRATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FYAVOLV, ETHINYL ESTRADIOL GATIFLOXACIN, GATIFLOXACIN HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN JENCYCLA, NORETHINDRONE KAITLIB FE, ETHINYL ESTRADIOL KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE, KETOROLAC TROMETHAMINE KURVELO, ETHINYL ESTRADIOL LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LAMOTRIGINE, LAMOTRIGINE LEFLUNOMIDE, LEFLUNOMIDE LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFENAMIC ACID, MEFENAMIC ACID MELOXICAM, MELOXICAM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NADOLOL, NADOLOL NIACIN, NIACIN NIKKI, DROSPIRENONE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLAMINE, PENICILLAMINE PIRMELLA 1/35, ETHINYL ESTRADIOL PIRMELLA 7/7/7, ETHINYL ESTRADIOL POTASSIUM CHLORIDE, POTASSIUM CHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUININE SULFATE, QUININE SULFATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM RANOLAZINE, RANOLAZINE , RIFABUTIN RUFINAMIDE, RUFINAMIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE SILODOSIN, SILODOSIN SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SUPRAX, CEFIXIME TADALAFIL, TADALAFIL TAVABOROLE, TAVABOROLE TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TESTOSTERONE, TESTOSTERONE TETRABENAZINE, TETRABENAZINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 115 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L ** * LUPIN LTD TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE TYDEMY, DROSPIRENONE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN, VALSARTAN VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VYFEMLA, ETHINYL ESTRADIOL ZILEUTON, ZILEUTON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE LUPIN PHARMS * LUPIN PHARMACEUTICALS INC AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE DESLORATADINE, DESLORATADINE DROXIDOPA, DROXIDOPA MELOXICAM, MELOXICAM NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL PRAVASTATIN SODIUM, PRAVASTATIN SODIUM RIFAMPIN, RIFAMPIN SUPRAX, CEFIXIME ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE LYMOL MEDCL * LYMOL MEDICAL CORP SCLEROSOL, TALC TALC, TALC LYNE * LYNE LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEXAMETHASONE, DEXAMETHASONE ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE LEVOCARNITINE, LEVOCARNITINE NYSTATIN, NYSTATIN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE PERRIGO * L PERRIGO CO ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) CHILDREN'S IBUPROFEN, IBUPROFEN (OTC) CROMOLYN SODIUM, CROMOLYN SODIUM (OTC) DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC) FAMOTIDINE, FAMOTIDINE (OTC) IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC) NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TAB-PROFEN, IBUPROFEN (OTC) TIOCONAZOLE, TIOCONAZOLE (OTC)

** M ** MA GENERAL HOSP * MASSACHUSETTS GENERAL HOSP FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 MACLEODS PHARMS LTD * MACLEODS PHARMACEUTICALS LTD ACYCLOVIR, ACYCLOVIR

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 116 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MACLEODS PHARMACEUTICALS LTD AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL CELECOXIB, CELECOXIB CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DARIFENACIN, DARIFENACIN HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ENTACAPONE, ENTACAPONE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESZOPICLONE, ESZOPICLONE FAMCICLOVIR, FAMCICLOVIR FLUOCINONIDE, FLUOCINONIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN LIDOCAINE, LIDOCAINE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE MONTELUKAST SODIUM, MONTELUKAST SODIUM NEVIRAPINE, NEVIRAPINE NYSTATIN, NYSTATIN OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PYRAZINAMIDE, PYRAZINAMIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RISEDRONATE SODIUM, RISEDRONATE SODIUM RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SILDENAFIL CITRATE, SILDENAFIL CITRATE SILODOSIN, SILODOSIN TADALAFIL, TADALAFIL TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN, VALSARTAN VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE MAIA PHARMS INC * MAIA PHARMACEUTICALS INC ANGIOMAX RTU, BIVALIRUDIN BACLOFEN, BACLOFEN LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE MAINPOINTE * MAINPOINTE PHARMACEUTICALS LLC TUXARIN ER, CHLORPHENIRAMINE MALEATE ARD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 117 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MALLINCKRODT ARD INC H.P. ACTHAR , CORTICOTROPIN MALLINCKRODT HOSP * MALLINCKRODT HOSP PRODUCTS IP LTD INOMAX, OFIRMEV, ACETAMINOPHEN UVADEX, METHOXSALEN MANKIND PHARMA * MANKIND PHARMA LTD ACETAZOLAMIDE, ACETAZOLAMIDE ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE FENOFIBRATE, FENOFIBRATE RANOLAZINE, RANOLAZINE TIMOLOL MALEATE, TIMOLOL MALEATE MARKSANS PHARMA * MARKSANS PHARMA LTD CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE DUTASTERIDE, DUTASTERIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) LORATADINE, LORATADINE (OTC) METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NAPROXEN, NAPROXEN PARICALCITOL, PARICALCITOL MARNEL PHARMS * MARNEL PHARMACEUTICALS LLC ALA-SCALP, HYDROCORTISONE CROTAN, CROTAMITON MAYNE PHARMA * MAYNE PHARMA INTERNATIONAL PTY LTD DORYX MPC, DOXYCYCLINE HYCLATE DORYX, DOXYCYCLINE HYCLATE ERYC, ERYTHROMYCIN * MAYNE PHARMA LLC BUDESONIDE, BUDESONIDE CAMILA, NORETHINDRONE CARBIDOPA AND LEVODOPA, CARBIDOPA CHLORZOXAZONE, CHLORZOXAZONE CLARITHROMYCIN, CLARITHROMYCIN CLONIDINE, CLONIDINE CLOZAPINE, CLOZAPINE CYCLOSPORINE, CYCLOSPORINE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIAZEPAM, DIAZEPAM DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ERRIN, NORETHINDRONE , ESTAZOLAM ESTRADIOL, ESTRADIOL FABIOR, TAZAROTENE FLUOROURACIL, FLUOROURACIL LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVORA 0.15/30-28, ETHINYL ESTRADIOL LEXETTE, HALOBETASOL PROPIONATE LOW-OGESTREL-28, ETHINYL ESTRADIOL METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 118 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MAYNE PHARMA LLC MICROGESTIN 1/20, ETHINYL ESTRADIOL MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL MICROGESTIN FE 1/20, ETHINYL ESTRADIOL NEXTSTELLIS, DROSPIRENONE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE SORILUX, CALCIPOTRIENE TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TOLCAPONE, TOLCAPONE TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL TRIMETHOPRIM, TRIMETHOPRIM TRIVORA-28, ETHINYL ESTRADIOL ZOVIA 1/35E-28, ETHINYL ESTRADIOL MAYNE PHARMA INC * MAYNE PHARMA INC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DOFETILIDE, DOFETILIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NYSTATIN, NYSTATIN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ASPIRIN, ASPIRIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE SOLTAMOX, TAMOXIFEN CITRATE MAYNE PHARMA INTL * MAYNE PHARMA INTERNATIONAL PTY LTD TOLSURA, ITRACONAZOLE MC2 * MC2 THERAPEUTICS LTD WYNZORA, BETAMETHASONE DIPROPIONATE MCGUFF * MCGUFF PHARMACEUTICALS INC ASCOR, ASCORBIC ACID MCNEIL * MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC IBUPROFEN, IBUPROFEN (OTC) MCNEIL CONS * MCNEIL CONSUMER HEALTHCARE SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) MCPRF * MAYO CLINIC PET RADIOCHEMISTRY FACILITY AMMONIA N 13, AMMONIA N-13 CHOLINE C-11, CHOLINE C-11 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 MDD US * MDD US OPERATIONS LLC APOKYN, HYDROCHLORIDE XADAGO, MESYLATE MDGH * MEDICINES DEVELOPMENT FOR GLOBAL HEALTH MOXIDECTIN, MOXIDECTIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 119 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** MEDEFIL INC * MEDEFIL INC CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION MEDEXUS * MEDEXUS PHARMA INC RASUVO, METHOTREXATE MEDICINES360 * MEDICINES360 LILETTA, LEVONORGESTREL MEDICURE * MEDICURE INTERNATIONAL INC AGGRASTAT, TIROFIBAN HYDROCHLORIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE ZYPITAMAG, PITAVASTATIN MAGNESIUM MEDIMETRIKS PHARMS * MEDIMETRIKS PHARMACEUTICALS INC BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE LOPROX, CICLOPIROX NEO-SYNALAR, FLUOCINOLONE ACETONIDE SYNALAR, FLUOCINOLONE ACETONIDE MEDLINE INDUSTRIES * MEDLINE INDUSTRIES INC READYPREP CHG, CHLORHEXIDINE GLUCONATE (OTC) MEDTECH PRODUCTS * MEDTECH PRODUCTS INC MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC) MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 3, MICONAZOLE NITRATE MONISTAT 3, MICONAZOLE NITRATE (OTC) MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MONISTAT 7, MICONAZOLE NITRATE (OTC) NIX, PERMETHRIN (OTC) TAGAMET HB, CIMETIDINE (OTC) MEITHEAL * MEITHEAL PHARMACEUTICALS INC ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AZACITIDINE, AZACITIDINE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUSULFAN, BUSULFAN CARBOPLATIN, CARBOPLATIN CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CLOFARABINE, CLOFARABINE CYTARABINE, CYTARABINE DACTINOMYCIN, DACTINOMYCIN DOXERCALCIFEROL, DOXERCALCIFEROL GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM MILRINONE LACTATE, MILRINONE LACTATE MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE MELINTA * MELINTA SUBSIDIARY CORP BAXDELA, MEGLUMINE MELINTA THERAP * LLC KIMYRSA, ORITAVANCIN DIPHOSPHATE ORBACTIV, ORITAVANCIN DIPHOSPHATE MEM SLOAN-KETTERING

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 120 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MEMORIAL SLOAN-KETTERING CENTER FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 MERCK * MERCK AND CO INC CANCIDAS, CASPOFUNGIN ACETATE EMEND, APREPITANT MAXALT, RIZATRIPTAN BENZOATE MAXALT-MLT, RIZATRIPTAN BENZOATE PRIMAXIN, CILASTATIN SODIUM PROSCAR, FINASTERIDE ZOLINZA, * MERCK RESEARCH LABORATORIES DIV MERCK CO INC PRINIVIL, LISINOPRIL PROPECIA, FINASTERIDE SINGULAIR, MONTELUKAST SODIUM TRUSOPT, DORZOLAMIDE HYDROCHLORIDE MERCK AND CO INC * MERCK AND CO INC EMEND, FOSAPREPITANT DIMEGLUMINE FOSAMAX, ALENDRONATE SODIUM MERCK SHARP DOHME * MERCK SHARP AND DOHME CORP BELSOMRA, CELESTONE SOLUSPAN, BETAMETHASONE ACETATE CLARINEX, DESLORATADINE DIPROLENE, BETAMETHASONE DIPROPIONATE ELOCON, MOMETASONE FUROATE INVANZ, ERTAPENEM SODIUM ISENTRESS HD, RALTEGRAVIR POTASSIUM ISENTRESS, RALTEGRAVIR POTASSIUM JANUMET XR, METFORMIN HYDROCHLORIDE JANUMET, METFORMIN HYDROCHLORIDE JANUVIA, SITAGLIPTIN PHOSPHATE LOTRISONE, BETAMETHASONE DIPROPIONATE NOXAFIL, POSACONAZOLE PREVYMIS, LETERMOVIR REBETOL, RIBAVIRIN SEGLUROMET, ERTUGLIFLOZIN SINEMET, CARBIDOPA STEGLATRO, ERTUGLIFLOZIN STEGLUJAN, ERTUGLIFLOZIN STROMECTOL, IVERMECTIN TEMODAR, TEMOZOLOMIDE VERQUVO, VERICIGUAT ZEPATIER, ELBASVIR MERIDIAN MEDCL * MERIDIAN MEDICAL TECHNOLOGIES INC DUODOTE, ATROPINE MERIDIAN MEDCL TECHN * MERIDIAN MEDICAL TECHNOLOGIES INC ATROPEN, ATROPINE SEIZALAM, MIDAZOLAM HYDROCHLORIDE MERZ PHARMS * MERZ PHARMACEUTICALS LLC CUVPOSA, GLYCOPYRROLATE METACEL PHARMS LLC * METACEL PHARMACEUTICALS LLC OZOBAX, BACLOFEN METHAPHARM * METHAPHARM INC PROVOCHOLINE, CHLORIDE METUCHEN PHARMS * METUCHEN PHARMACEUTICALS LLC STENDRA,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 121 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** MICRO LABS * MICRO LABS LTD AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE BIMATOPROST, BIMATOPROST BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CELECOXIB, CELECOXIB CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLOBAZAM, CLOBAZAM CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE DALFAMPRIDINE, DALFAMPRIDINE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE GLIMEPIRIDE, GLIMEPIRIDE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEFENAMIC ACID, MEFENAMIC ACID METHENAMINE HIPPURATE, METHENAMINE HIPPURATE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL PIROXICAM, PIROXICAM RANOLAZINE, RANOLAZINE RASAGILINE MESYLATE, RASAGILINE MESYLATE SIMVASTATIN, SIMVASTATIN SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TAFLUPROST, TAFLUPROST TELMISARTAN, TELMISARTAN TRANEXAMIC ACID, TRANEXAMIC ACID TRAVOPROST, TRAVOPROST VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE MICRO LABS LTD * MICRO LABS LTD NEVIRAPINE, NEVIRAPINE MICRO LABS LTD INDIA * MICRO LABS LTD INDIA ACETAZOLAMIDE, ACETAZOLAMIDE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM CROMOLYN SODIUM, CROMOLYN SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LEVOFLOXACIN, LEVOFLOXACIN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN MIDWEST MEDCL * MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV AMMONIA N 13, AMMONIA N-13 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 MIKART * MIKART LLC BENZONATATE, BENZONATATE BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTAPAP, ACETAMINOPHEN CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE CHLORZOXAZONE, CHLORZOXAZONE TARTRATE AND CAFFEINE, CAFFEINE ETHOSUXIMIDE, ETHOSUXIMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN METHAZOLAMIDE, METHAZOLAMIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 122 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MIKART LLC HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE MIKART INC * MIKART INC OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN MILLA PHARMS * MILLA PHARMACEUTICALS INC SODIUM ACETATE, SODIUM ACETATE MILLICENT * MILLICENT HOLDINGS LTD FEMRING, * MILLICENT PHARMA LTD INTRAROSA, MIPS CRF * MIPS CYCLOTRON AND RADIOCHEMISTRY FACILITY AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 MISEMER * MISEMER PHARMACEUTICALS INC CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE MISSION PHARMA * MISSION PHARMACAL CO LITHOSTAT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE TEXACORT, HYDROCORTISONE THIOLA, TINDAMAX, TINIDAZOLE UROCIT-K, POTASSIUM CITRATE MISSION PHARMACAL CO * MISSION PHARMACAL CO CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE POTASSIUM IODIDE, POTASSIUM IODIDE (OTC) THIOLA EC, TIOPRONIN MITSUBISHI HOLDINGS * MITSUBISHI TANABE PHARMA HOLDINGS AMERICA INC EXSERVAN, RILUZOLE MITSUBISHI TANABE * MITSUBISHI TANABE PHARMA CORP RADICAVA, EDARAVONE MLV * MLV PHARMA LLC CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE MOBIUS THERAP * MOBIUS THERAPEUTICS LLC MITOSOL, MITOMYCIN MOLNLYCKE HLTH * MOLNLYCKE HEALTH CARE HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC) HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC) MONARCH PHARMS * MONARCH PHARMACEUTICALS LLC CORTISPORIN, BACITRACIN ZINC CORTISPORIN, MENEST, , ESTERIFIED NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, GRAMICIDIN SEPTRA DS, SULFAMETHOXAZOLE SEPTRA, SULFAMETHOXAZOLE VIROPTIC, TRIFLURIDINE MONTEREY PHARMS LLC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 123 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MONTEREY PHARMACEUTICALS LLC METHOCARBAMOL, METHOCARBAMOL MOUNTAIN * MOUNTAIN LLC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE METAXALONE, METAXALONE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MSD MERCK CO * MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC DELSTRIGO, DORAVIRINE EMEND, APREPITANT NOXAFIL POWDERMIX KIT, POSACONAZOLE PIFELTRO, DORAVIRINE RECARBRIO, CILASTATIN SODIUM SINGULAIR, MONTELUKAST SODIUM MSN * MSN LABORATORIES PRIVATE LTD ABIRATERONE ACETATE, ABIRATERONE ACETATE ALBENDAZOLE, ALBENDAZOLE AMINOCAPROIC ACID, AMINOCAPROIC ACID ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM CAPECITABINE, CAPECITABINE CLOBAZAM, CLOBAZAM CLOFARABINE, CLOFARABINE DECITABINE, DECITABINE DEFERASIROX, DEFERASIROX DIMETHYL FUMARATE, DIMETHYL FUMARATE DOFETILIDE, DOFETILIDE ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE FEBUXOSTAT, FEBUXOSTAT FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PACLITAXEL, PACLITAXEL PREGABALIN, PREGABALIN ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SILODOSIN, SILODOSIN SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE THIOTEPA, THIOTEPA TOREMIFENE CITRATE, TOREMIFENE CITRATE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE MSN PHARMS INC * MSN PHARMACEUTICALS INC DROXIDOPA, DROXIDOPA MURTY PHARMS * MURTY PHARMACEUTICALS INC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE * MYLAN PHARMACEUTICALS METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE * MYLAN PHARMACEUTICALS INC ABIRATERONE ACETATE, ABIRATERONE ACETATE ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE ACETAMINOPHEN, ACETAMINOPHEN ACITRETIN, ACITRETIN ALBUTEROL SULFATE, ALBUTEROL SULFATE ALLOPURINOL, ALLOPURINOL ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE AMBRISENTAN, AMBRISENTAN AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 124 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN PHARMACEUTICALS INC ATENOLOL, ATENOLOL ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE AVITA, TRETINOIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BEPOTASTINE BESILATE, BEPOTASTINE BESILATE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE MESYLATE, BROMOCRIPTINE MESYLATE BUDESONIDE, BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL CAPECITABINE, CAPECITABINE CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL CAPTOPRIL, CAPTOPRIL CARBIDOPA AND LEVODOPA, CARBIDOPA CARVEDILOL, CARVEDILOL CELECOXIB, CELECOXIB CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHLORTHALIDONE, CHLORTHALIDONE CIMETIDINE, CIMETIDINE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE CLOBAZAM, CLOBAZAM CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLOZAPINE, CLOZAPINE COLCHICINE, COLCHICINE CYSTAGON, CYSTEAMINE BITARTRATE DENAVIR, PENCICLOVIR DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DIAZEPAM, DIAZEPAM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE EFAVIRENZ, EFAVIRENZ ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE ERYGEL, ERYTHROMYCIN ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) ESTRADIOL, ESTRADIOL ETOPOSIDE, ETOPOSIDE EVEROLIMUS, EVEROLIMUS EVOCLIN, CLINDAMYCIN PHOSPHATE EXEMESTANE, EXEMESTANE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTINA, KETOCONAZOLE FEBUXOSTAT, FEBUXOSTAT FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 125 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN PHARMACEUTICALS INC FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE FUROSEMIDE, FUROSEMIDE GLATIRAMER ACETATE, GLATIRAMER ACETATE GLIPIZIDE, GLIPIZIDE , HALCINONIDE HALOPERIDOL, HALOPERIDOL HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IMATINIB MESYLATE, IMATINIB MESYLATE IMPEKLO, CLOBETASOL PROPIONATE INDAPAMIDE, INDAPAMIDE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LANSOPRAZOLE, LANSOPRAZOLE LANSOPRAZOLE, LANSOPRAZOLE (OTC) LEVETIRACETAM, LEVETIRACETAM LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ** LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LORATADINE, LORATADINE (OTC) LOXAPINE SUCCINATE, LOXAPINE SUCCINATE LUXIQ, BETAMETHASONE VALERATE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MENTAX, BUTENAFINE HYDROCHLORIDE MERCAPTOPURINE, MERCAPTOPURINE MESALAMINE, MESALAMINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHIMAZOLE, METHIMAZOLE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLDOPA, METHYLDOPA METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOLAZONE, METOLAZONE METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NADOLOL, NADOLOL NEVIRAPINE, NEVIRAPINE NIFEDIPINE, NIFEDIPINE NISOLDIPINE, NISOLDIPINE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) OLUX E, CLOBETASOL PROPIONATE OLUX, CLOBETASOL PROPIONATE ONDANSETRON, ONDANSETRON PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE PERPHENAZINE, PERPHENAZINE PHENYTEK, PHENYTOIN SODIUM POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PRASUGREL, PRASUGREL HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PREDNISONE, PREDNISONE PREGABALIN, PREGABALIN PROBENECID, PROBENECID PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 126 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN PHARMACEUTICALS INC PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RASAGILINE MESYLATE, RASAGILINE MESYLATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE RUFINAMIDE, RUFINAMIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE SULINDAC, SULINDAC SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SYMFI LO, EFAVIRENZ TACROLIMUS, TACROLIMUS TADALAFIL, TADALAFIL TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE TELMISARTAN, TELMISARTAN TEMAZEPAM, TEMAZEPAM TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE TETRABENAZINE, TETRABENAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE THIOTHIXENE, THIOTHIXENE TIMOLOL MALEATE, TIMOLOL MALEATE SODIUM, TOLMETIN SODIUM TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAVOPROST, TRAVOPROST TRETINOIN, TRETINOIN TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE TRILYTE, POLYETHYLENE GLYCOL 3350 URSODIOL, URSODIOL VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE VALSARTAN, VALSARTAN VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VUSION, MICONAZOLE NITRATE WIXELA INHUB, FLUTICASONE PROPIONATE ZONALON, DOXEPIN HYDROCHLORIDE ZOVIRAX, ACYCLOVIR * MYLAN PHARMACEUTICALS INC A CO PREGABALIN, PREGABALIN MYLAN ASI * MYLAN ASI LLC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ADENOSINE, ADENOSINE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE MYLAN INSTITUTIONAL * MYLAN INSTITUTIONAL INC BUSULFAN, BUSULFAN SULFAMYLON, ACETATE * MYLAN INSTITUTIONAL LLC ALOPRIM, ALLOPURINOL SODIUM AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ARGATROBAN, ARGATROBAN AZACITIDINE, AZACITIDINE BIVALIRUDIN, BIVALIRUDIN CIDOFOVIR, CIDOFOVIR COSYNTROPIN, COSYNTROPIN DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DURACLON, CLONIDINE HYDROCHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 127 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN INSTITUTIONAL LLC ETHACRYNATE SODIUM, ETHACRYNATE SODIUM FOMEPIZOLE, FOMEPIZOLE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE FUMARATE, IBUTILIDE FUMARATE ISOSULFAN BLUE, ISOSULFAN BLUE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE RIMSO-50, DIMETHYL ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SOTRADECOL, SODIUM TETRADECYL SULFATE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE TRANEXAMIC ACID, TRANEXAMIC ACID ULTIVA, REMIFENTANIL HYDROCHLORIDE MYLAN IRELAND LTD * MYLAN IRELAND LTD ARIXTRA, FONDAPARINUX SODIUM MIACALCIN, CALCITONIN SALMON PRETOMANID, PRETOMANID YUPELRI, MYLAN LABS LTD * MYLAN LABORATORIES LTD ADENOSINE, ADENOSINE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM BACLOFEN, BACLOFEN CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE CIMDUO, LAMIVUDINE CLADRIBINE, CLADRIBINE CLOFARABINE, CLOFARABINE CYANOCOBALAMIN, CYANOCOBALAMIN CYTARABINE, CYTARABINE DAPTOMYCIN, DAPTOMYCIN DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DOCETAXEL, DOCETAXEL DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE HYCLATE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE EPTIFIBATIDE, EPTIFIBATIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL ETOMIDATE, ETOMIDATE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FLUMAZENIL, FLUMAZENIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM, HEPARIN SODIUM IBANDRONATE SODIUM, IBANDRONATE SODIUM LAMIVUDINE, LAMIVUDINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 128 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN LABORATORIES LTD LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL (OTC) LINEZOLID, LINEZOLID MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL OXALIPLATIN, OXALIPLATIN PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PARICALCITOL, PARICALCITOL PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SYMFI, EFAVIRENZ TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID MYLAN PHARMS INC * MYLAN PHARMACEUTICALS INC ABACAVIR SULFATE, ABACAVIR SULFATE ACYCLOVIR, ACYCLOVIR AMNESTEEM, ISOTRETINOIN ARMODAFINIL, ARMODAFINIL ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AVITA, TRETINOIN CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIGOXIN, DIGOXIN DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE ESZOPICLONE, ESZOPICLONE FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE LANSOPRAZOLE, LANSOPRAZOLE LITHIUM CARBONATE, LITHIUM CARBONATE MAXZIDE, HYDROCHLOROTHIAZIDE MAXZIDE-25, HYDROCHLOROTHIAZIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MODAFINIL, MODAFINIL NEVIRAPINE, NEVIRAPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PHENYTOIN, PHENYTOIN PINDOLOL, PINDOLOL PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE RILUZOLE, RILUZOLE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 129 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M ** * MYLAN PHARMACEUTICALS INC SILDENAFIL CITRATE, SILDENAFIL CITRATE , TOLBUTAMIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VORICONAZOLE, VORICONAZOLE ZIDOVUDINE, ZIDOVUDINE * MYLAN PHARMACEUTICALS INC. FLUVASTATIN SODIUM, FLUVASTATIN SODIUM MYLAN SPECIALITY LP * MYLAN SPECIALTY LP ACCUNEB, ALBUTEROL SULFATE ASTELIN, AZELASTINE HYDROCHLORIDE ASTEPRO, AZELASTINE HYDROCHLORIDE COLYTE WITH PACKS, POLYETHYLENE GLYCOL 3350 CORTIFOAM, HYDROCORTISONE ACETATE DEPEN, PENICILLAMINE DIPENTUM, OLSALAZINE SODIUM DYMISTA, AZELASTINE HYDROCHLORIDE EDLUAR, ZOLPIDEM TARTRATE ELESTRIN, ESTRADIOL EPIFOAM, HYDROCORTISONE ACETATE EPIPEN JR., EPINEPHRINE EPIPEN, EPINEPHRINE FELBATOL, FELBAMATE GASTROCROM, CROMOLYN SODIUM LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE MUSE, ALPROSTADIL PROCTOFOAM HC, HYDROCORTISONE ACETATE ROWASA, MESALAMINE SFROWASA, MESALAMINE SOMA, CARISOPRODOL TOBI PODHALER, TOBRAMYCIN TOBI, TOBRAMYCIN MYLAN SPECLT * MYLAN SPECIALTY LP PERFOROMIST, FORMOTEROL FUMARATE MYLAN TECHNOLOGIES * MYLAN TECHNOLOGIES BUPRENORPHINE, BUPRENORPHINE * MYLAN TECHNOLOGIES INC BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CLONIDINE, CLONIDINE ESTRADIOL, ESTRADIOL FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-37, FENTANYL FENTANYL-50, FENTANYL FENTANYL-62, FENTANYL FENTANYL-75, FENTANYL FENTANYL-87, FENTANYL LIDOCAINE, LIDOCAINE NITROGLYCERIN, NITROGLYCERIN RIVASTIGMINE, RIVASTIGMINE SCOPOLAMINE, SCOPOLAMINE XULANE, ETHINYL ESTRADIOL MYOVANT SCIENCES * MYOVANT SCIENCES GMBH MYFEMBREE, ESTRADIOL ORGOVYX,

** N ** NAARI PTE LTD * NAARI PTE LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 130 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NAARI PTE LTD DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL (OTC) NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NORETHINDRONE, NORETHINDRONE NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL NABRIVA * NABRIVA THERAPEUTICS IRELAND DAC XENLETA, ACETATE NAL PHARM * NAL PHARMACEUTICAL GROUP LTD LIDOCAINE, LIDOCAINE NALPROPION * NALPROPION PHARMACEUTICALS LLC CONTRAVE, BUPROPION HYDROCHLORIDE NAMIGEN LLC * NAMIGEN LLC ACYCLOVIR SODIUM, ACYCLOVIR SODIUM NANG KUANG PHARM CO * NANG KUANG PHARMACEUTICAL CO LTD IBANDRONATE SODIUM, IBANDRONATE SODIUM ICATIBANT ACETATE, ICATIBANT ACETATE LINEZOLID, LINEZOLID NANJING * NANJING SIMCERE DONGYUAN PHARMACEUTICAL CO LTD CELECOXIB, CELECOXIB NANJING KING-FRIEND * NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM NAPO PHARMS INC * NAPO PHARMACEUTICALS INC MYTESI, * NATCO PHARMA LTD GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE NATCO PHARMA LTD * NATCO PHARMA LIMITED CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE * NATCO PHARMA LTD ALPRAZOLAM, ALPRAZOLAM ANASTROZOLE, ANASTROZOLE ARMODAFINIL, ARMODAFINIL AZACITIDINE, AZACITIDINE BOSENTAN, BOSENTAN CARISOPRODOL, CARISOPRODOL CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE GLYCOPYRROLATE, GLYCOPYRROLATE IMATINIB MESYLATE, IMATINIB MESYLATE LANSOPRAZOLE, LANSOPRAZOLE LANSOPRAZOLE, LANSOPRAZOLE (OTC) CARBONATE, DITOSYLATE, LAPATINIB DITOSYLATE LENALIDOMIDE, LENALIDOMIDE LETROZOLE, LETROZOLE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 131 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** NAVINTA LLC * NAVINTA LLC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CARMUSTINE, CARMUSTINE FAMOTIDINE, FAMOTIDINE FOMEPIZOLE, FOMEPIZOLE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE INDOMETHACIN SODIUM, INDOMETHACIN SODIUM METHOCARBAMOL, METHOCARBAMOL REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE RIBAVIRIN, RIBAVIRIN ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE NCM USA BRONX LLC * NCM USA BRONX LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 NEOS THERAP INC * NEOS THERAPEUTICS INC HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX NEOS THERAPS * NEOS THERAPEUTICS ADZENYS XR-ODT, AMPHETAMINE NEOS THERAPS INC * NEOS THERAPEUTICS INC ADZENYS ER, AMPHETAMINE COTEMPLA XR-ODT, METHYLPHENIDATE NEPHRON * NEPHRON CORP ALBUTEROL SULFATE, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE * NEPHRON PHARMACEUTICALS CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE BUDESONIDE, BUDESONIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION NESHER PHARMS * NESHER PHARMACEUTICALS USA LLC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE MORPHINE SULFATE, MORPHINE SULFATE NYSTATIN, NYSTATIN OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN NEURELIS INC * NEURELIS INC VALTOCO, DIAZEPAM NEUROCRINE * NEUROCRINE BIOSCIENCES INC INGREZZA, VALBENAZINE TOSYLATE ONGENTYS, NEXTWAVE * NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE PHARMS * NEXTWAVE PHARMACEUTICALS INC QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 132 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** NEXUS PHARMS * NEXUS PHARMACEUTICALS INC ARSENIC TRIOXIDE, ARSENIC TRIOXIDE BUSULFAN, BUSULFAN COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE EMERPHED, EPHEDRINE SULFATE ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM POTASSIUM CHLORIDE 10MEQ, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ, POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ, POTASSIUM CHLORIDE PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE NIAGARA PHARMS * NIAGARA PHARMACEUTICALS INC PUR-WASH, PURIFIED WATER (OTC) NIPPON SHINYAKU * NIPPON SHINYAKU CO LTD VILTEPSO, VILTOLARSEN NIVAGEN PHARMS INC * NIVAGEN PHARMACEUTICALS INC DECITABINE, DECITABINE NYSTATIN, NYSTATIN SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE NODEN PHARMA * NODEN PHARMA DAC TEKTURNA HCT, ALISKIREN HEMIFUMARATE TEKTURNA, ALISKIREN HEMIFUMARATE NORTEC DEV ASSOC * NORTEC DEVELOPMENT ASSOC INC PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE NORTHLAND * NORTHLAND NUCLEAR MEDICINE LLC FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 NORTHSTAR HLTHCARE * NORTHSTAR HEALTHCARE HOLDINGS LTD ALLOPURINOL, ALLOPURINOL BACLOFEN, BACLOFEN GEMFIBROZIL, GEMFIBROZIL HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE NORTHSTAR MEDICAL * NORTHSTAR MEDICAL RADIOISOTOPES LLC RADIOGENIX SYSTEM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR NORTON WATERFORD * NORTON WATERFORD LTD QVAR REDIHALER, BECLOMETHASONE DIPROPIONATE NOSTRUM LABS INC * NOSTRUM LABORATORIES INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAZOLAMIDE, ACETAZOLAMIDE BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN CALCIUM ACETATE, CALCIUM ACETATE CARBAMAZEPINE, CARBAMAZEPINE CARISOPRODOL, CARISOPRODOL DAPSONE, DAPSONE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE ELIXOPHYLLIN, THEOPHYLLINE HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 133 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NOSTRUM LABORATORIES INC METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE NITROFURANTOIN, NITROFURANTOIN PINDOLOL, PINDOLOL PIROXICAM, PIROXICAM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROMETH VC W/ CODEINE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SUCRALFATE, SUCRALFATE THEOPHYLLINE, THEOPHYLLINE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE NOSTRUM PHARMS LLC * NOSTRUM PHARMACEUTICALS LLC METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE THEOCHRON, THEOPHYLLINE NOVA LABS LTD * NOVA LABORATORIES LTD PURIXAN, MERCAPTOPURINE NOVADAQ TECH * NOVADAQ TECHNOLOGIES ULC SPY AGENT GREEN KIT, INDOCYANINE GREEN * NOVARTIS PHARMACEUTICALS CORP AFINITOR, EVEROLIMUS ALOMIDE, TROMETHAMINE ARGATROBAN, ARGATROBAN ARRANON, AZOPT, BRINZOLAMIDE BETOPTIC S, BETAXOLOL HYDROCHLORIDE CILOXAN, CIPROFLOXACIN HYDROCHLORIDE CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE CIPRODEX, CIPROFLOXACIN COARTEM, DESFERAL, DEFEROXAMINE MESYLATE DIOVAN HCT, HYDROCHLOROTHIAZIDE DIOVAN, VALSARTAN DUREZOL, EGATEN, TRICLABENDAZOLE , RIVASTIGMINE EXFORGE HCT, AMLODIPINE BESYLATE EXFORGE, AMLODIPINE BESYLATE EXJADE, DEFERASIROX FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE GILENYA, FINGOLIMOD HYDROCHLORIDE GLEEVEC, IMATINIB MESYLATE HYCAMTIN, TOPOTECAN HYDROCHLORIDE ILEVRO, NEPAFENAC IOPIDINE, APRACLONIDINE HYDROCHLORIDE ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE JADENU SPRINKLE, DEFERASIROX KISQALI FEMARA CO-PACK (COPACKAGED), LETROZOLE KISQALI, SUCCINATE LAMISIL, TERBINAFINE HYDROCHLORIDE LESCOL XL, FLUVASTATIN SODIUM LOTREL, AMLODIPINE BESYLATE MAXIDEX, DEXAMETHASONE MAXITROL, DEXAMETHASONE MAYZENT, SIPONIMOD MEKINIST, MOXEZA, MOXIFLOXACIN HYDROCHLORIDE MYFORTIC, MYCOPHENOLIC ACID NEORAL, CYCLOSPORINE NEVANAC, NEPAFENAC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 134 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NOVARTIS PHARMACEUTICALS CORP OMNIPRED, PREDNISOLONE ACETATE PATANASE, OLOPATADINE HYDROCHLORIDE PIQRAY, PROMACTA KIT, OLAMINE PROMACTA, ELTROMBOPAG OLAMINE RECLAST, ZOLEDRONIC ACID RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE RITALIN, METHYLPHENIDATE HYDROCHLORIDE RYDAPT, SANDIMMUNE, CYCLOSPORINE SANDOSTATIN LAR, OCTREOTIDE ACETATE SANDOSTATIN, OCTREOTIDE ACETATE SIMBRINZA, BRIMONIDINE TARTRATE TAFINLAR, MESYLATE TASIGNA, HYDROCHLORIDE TEGRETOL, CARBAMAZEPINE TEGRETOL-XR, CARBAMAZEPINE TOBRADEX, DEXAMETHASONE TOBREX, TOBRAMYCIN TRAVATAN Z, TRAVOPROST TRIESENCE, TRIAMCINOLONE ACETONIDE TRILEPTAL, OXCARBAZEPINE TYKERB, LAPATINIB DITOSYLATE VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE VIVELLE-DOT, ESTRADIOL VOLTAREN, DICLOFENAC SODIUM VOTRIENT, HYDROCHLORIDE XIIDRA, ZOFRAN ODT, ONDANSETRON ZOFRAN, ONDANSETRON HYDROCHLORIDE ZOMETA, ZOLEDRONIC ACID ZORTRESS, EVEROLIMUS ZYKADIA, NOVARTIS PHARM * NOVARTIS PHARMACEUTICAL CORP AFINITOR DISPERZ, EVEROLIMUS TABRECTA, HYDROCHLORIDE NOVARTIS PHARMS * NOVARTIS PHARMACEUTICALS CORP FEMARA, LETROZOLE NOVARTIS PHARMS CORP * NOVARTIS PHARMACEUTICALS CORP ENTRESTO, JADENU, DEFERASIROX NOVAST LABS * NOVAST LABORATORIES CHINA LTD NORETHINDRONE, NORETHINDRONE * NOVAST LABORATORIES LTD ACETAZOLAMIDE, ACETAZOLAMIDE CARBOPLATIN, CARBOPLATIN CARISOPRODOL, CARISOPRODOL CHABELINA FE, ETHINYL ESTRADIOL CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOLISHALE, ETHINYL ESTRADIOL ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL HER STYLE, LEVONORGESTREL (OTC) INDOMETHACIN, INDOMETHACIN IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LARIN 1.5/30, ETHINYL ESTRADIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 135 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NOVAST LABORATORIES LTD LARIN 1/20, ETHINYL ESTRADIOL LARIN 24 FE, ETHINYL ESTRADIOL LARIN FE 1.5/30, ETHINYL ESTRADIOL LARIN FE 1/20, ETHINYL ESTRADIOL LERIBANE, ETHINYL ESTRADIOL LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM LO-MALMOREDE, ETHINYL ESTRADIOL MAFENIDE ACETATE, MAFENIDE ACETATE MALMOREDE, ETHINYL ESTRADIOL MELAMISA, DROSPIRENONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE NIFEDIPINE, NIFEDIPINE NORETHINDRONE ACETATE, NORETHINDRONE ACETATE NORETHINDRONE, NORETHINDRONE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PIMTREA, DESOGESTREL PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE PROBENECID AND COLCHICINE, COLCHICINE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUININE SULFATE, QUININE SULFATE SETLAKIN, ETHINYL ESTRADIOL TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOLCAPONE, TOLCAPONE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE YAELA, DROSPIRENONE NOVAST LABS LTD * NOVAST LABORATORIES LTD DASETTA 1/35, ETHINYL ESTRADIOL DASETTA 7/7/7, ETHINYL ESTRADIOL ELINEST, ETHINYL ESTRADIOL FALMINA, ETHINYL ESTRADIOL LEVONEST, ETHINYL ESTRADIOL MONO-LINYAH, ETHINYL ESTRADIOL PHILITH, ETHINYL ESTRADIOL TRI-LINYAH, ETHINYL ESTRADIOL WERA, ETHINYL ESTRADIOL NOVATECH SA * NOVATECH SA STERITALC, TALC NOVEL LABS INC * NOVEL LABORATORIES INC AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE CALCIPOTRIENE, CALCIPOTRIENE CARBIDOPA, CARBIDOPA CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESOXIMETASONE, DESOXIMETASONE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DICLOFENAC SODIUM, DICLOFENAC SODIUM DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE FAMOTIDINE, FAMOTIDINE FLUCYTOSINE, FLUCYTOSINE FLUOCINONIDE, FLUOCINONIDE HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE LEVONORGESTREL, LEVONORGESTREL (OTC) LINEZOLID, LINEZOLID METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 136 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NOVEL LABORATORIES INC METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MISOPROSTOL, MISOPROSTOL MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC, MORPHINE SULFATE, MORPHINE SULFATE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NITROFURANTOIN, NITROFURANTOIN NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND SULFATE, PHENELZINE SULFATE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POTASSIUM CHLORIDE, POTASSIUM CHLORIDE SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE TEMAZEPAM, TEMAZEPAM TINIDAZOLE, TINIDAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIMETHOPRIM, TRIMETHOPRIM VORICONAZOLE, VORICONAZOLE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE NOVELGENIX THERAPS * NOVELGENIX THERAPEUTICS PVT LTD AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE NOVEN * NOVEN PHARMACEUTICALS INC MINIVELLE, ESTRADIOL NOVEN PHARMS INC * NOVEN PHARMACEUTICALS INC COMBIPATCH, ESTRADIOL DAYTRANA, METHYLPHENIDATE NOVITIUM PHARMA * NOVITIUM PHARMA LLC ACETAZOLAMIDE, ACETAZOLAMIDE ACYCLOVIR, ACYCLOVIR ALPRAZOLAM, ALPRAZOLAM CHLORZOXAZONE, CHLORZOXAZONE CLOTRIMAZOLE, CLOTRIMAZOLE DAPSONE, DAPSONE DIAZOXIDE, DIAZOXIDE DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE ESTAZOLAM, ESTAZOLAM FAMOTIDINE, FAMOTIDINE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE LEVOCARNITINE SF, LEVOCARNITINE LEVOCARNITINE, LEVOCARNITINE TARTRATE, LEVORPHANOL TARTRATE MELOXICAM, MELOXICAM NAPROXEN, NAPROXEN NITISINONE, NITISINONE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PREDNISONE, PREDNISONE PYRAZINAMIDE, PYRAZINAMIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SILDENAFIL CITRATE, SILDENAFIL CITRATE SIROLIMUS, SIROLIMUS THIOTHIXENE, THIOTHIXENE TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 137 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N ** * NOVITIUM PHARMA LLC TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE NOVO * NOVO NORDISK INC MACRILEN, MACIMORELIN ACETATE OZEMPIC, RYBELSUS, SEMAGLUTIDE SAXENDA, RECOMBINANT WEGOVY, SEMAGLUTIDE NOVO NORDISK * NOVO NORDISK PHARMACEUTICALS INC GLUCAGEN, GLUCAGON HYDROCHLORIDE NOVO NORDISK INC * NOVO NORDISK INC VAGIFEM, ESTRADIOL VICTOZA, LIRAGLUTIDE RECOMBINANT NOVOCOL INC * NOVOCOL INC DYCLOPRO, DYCLONINE HYDROCHLORIDE NPS PHARMS INC * NPS PHARMACEUTICALS INC GATTEX KIT, RECOMBINANT NUKEMED * NUKEMED INC DBA SPECTRONRX AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 NUVO PHARM * NUVO PHARMACEUTICAL INC DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE NUVO PHARMS INC * NUVO PHAMACEUTICALS INC BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE FOLIC ACID, FOLIC ACID HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE NAPROXEN, NAPROXEN POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE SULFASALAZINE, SULFASALAZINE NXDC * NX DEVELOPMENT CORP GLEOLAN, AMINOLEVULINIC ACID HYDROCHLORIDE

** O ** OCULAR THERAPEUTIX * OCULAR THERAPEUTIX INC DEXTENZA, DEXAMETHASONE ODYSSEY PHARMS * ODYSSEY PHARMACEUTICALS INC ANTABUSE, DISULFIRAM OHM * OHM CORP IBUPROFEN, IBUPROFEN (OTC) OHM LABS * OHM LABORATORIES INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) IBUPROHM COLD AND SINUS, IBUPROFEN (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) OHM LABS INC * OHM LABORATORIES INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 138 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O ** * OHM LABORATORIES INC EZETIMIBE, EZETIMIBE VALSARTAN, VALSARTAN OMEROS * OMEROS CORP OMIDRIA, KETOROLAC TROMETHAMINE ONCOPEPTIDES AB * ONCOPEPTIDES AB PEPAXTO, MELPHALAN FLUFENAMIDE HYDROCHLORIDE ONYX THERAP * ONYX THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC KYPROLIS, CARFILZOMIB OPTINOSE US INC * OPTINOSE US INC XHANCE, FLUTICASONE PROPIONATE ORANGE * ORANGE PHARMACEUTICALS USA LLC ERYTHROMYCIN, ERYTHROMYCIN ORAPHARMA * ORAPHARMA INC ARESTIN, MINOCYCLINE HYDROCHLORIDE ORCHID HLTHCARE * ORCHID HEALTHCARE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFUROXIME AXETIL, CEFUROXIME AXETIL CEPHALEXIN, CEPHALEXIN CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM ESZOPICLONE, ESZOPICLONE FELODIPINE, FELODIPINE GEMIFLOXACIN MESYLATE, GEMIFLOXACIN MESYLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM LEVETIRACETAM, LEVETIRACETAM LEVOFLOXACIN, LEVOFLOXACIN MODAFINIL, MODAFINIL NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE OLANZAPINE, OLANZAPINE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM RASAGILINE MESYLATE, RASAGILINE MESYLATE RISEDRONATE SODIUM, RISEDRONATE SODIUM RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZALEPLON, ZALEPLON ZOLMITRIPTAN, ZOLMITRIPTAN OREXO US INC * OREXO US INC ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE ORGANON * ORGANON LLC ASMANEX HFA, MOMETASONE FUROATE ASMANEX TWISTHALER, MOMETASONE FUROATE CLARINEX-D 12 HOUR, DESLORATADINE DULERA, FORMOTEROL FUMARATE FOSAMAX PLUS D, ALENDRONATE SODIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 139 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O ** * ORGANON LLC A SUB OF ORGANON AND CO COZAAR, LOSARTAN POTASSIUM HYZAAR, HYDROCHLOROTHIAZIDE VYTORIN, EZETIMIBE ZETIA, EZETIMIBE ZOCOR, SIMVASTATIN ORGANON SUB MERCK * ORGANON USA INC A SUB OF MERCK AND CO INC BRIDION, SODIUM NUVARING, ETHINYL ESTRADIOL ORGANON USA INC * ORGANON USA INC ACETATE, GANIRELIX ACETATE NEXPLANON, REMERON SOLTAB, MIRTAZAPINE REMERON, MIRTAZAPINE ORIENT PHARMA CO LTD * ORIENT PHARMA CO LTD CARISOPRODOL, CARISOPRODOL GLYBURIDE, GLYBURIDE , MIGLITOL PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ORIGIN * ORIGIN BIOSCIENCES INC NULIBRY, FOSDENOPTERIN HYDROBROMIDE ORION PHARMA * ORION PHARMA COMTAN, ENTACAPONE STALEVO 100, CARBIDOPA STALEVO 125, CARBIDOPA STALEVO 150, CARBIDOPA STALEVO 200, CARBIDOPA STALEVO 50, CARBIDOPA STALEVO 75, CARBIDOPA ORPHAN * ORPHAN EUROPE SARL CYSTADANE, BETAINE OSI PHARMS * OSI PHARMACEUTICALS LLC TARCEVA, ERLOTINIB HYDROCHLORIDE OSMOTICA * OSMOTICA KERESKEDELMI ES SZOLGALTATO KFT HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OSMOTICA PHARM * OSMOTICA PHARMACEUTICAL CORP VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM US * OSMOTICA PHARMACEUTICAL US LLC NIFEDIPINE, NIFEDIPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OTSUKA * OTSUKA PHARMACEUTICAL CO LTD ABILIFY MYCITE KIT, ARIPIPRAZOLE ABILIFY, ARIPIPRAZOLE DACOGEN, DECITABINE INQOVI, CEDAZURIDINE JYNARQUE, TOLVAPTAN REXULTI, SAMSCA, TOLVAPTAN OTSUKA PHARM * OTSUKA PHARMACEUTICAL CO LTD BUSULFEX, BUSULFAN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 140 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O ** OTSUKA PHARM CO LTD * OTSUKA PHARMACEUTICAL CO LTD ABILIFY MAINTENA KIT, ARIPIPRAZOLE OUTLOOK PHARMS * OUTLOOK PHARMACEUTICALS INC DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE OVERSEAS * OVERSEAS PHARMACEUTICALS LTD LEVETIRACETAM, LEVETIRACETAM OXFORD PHARMS * OXFORD PHARMACEUTICALS LLC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BACLOFEN, BACLOFEN BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARISOPRODOL, CARISOPRODOL CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LORAZEPAM, LORAZEPAM METHOCARBAMOL, METHOCARBAMOL METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PRIMIDONE, PRIMIDONE RIMACTANE, RIFAMPIN SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SPIRONOLACTONE, SPIRONOLACTONE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

** P ** P AND L * P AND L DEVELOPMENT LLC ADAPALENE, ADAPALENE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) DOCOSANOL, DOCOSANOL (OTC) FAMOTIDINE, FAMOTIDINE (OTC) IBUPROFEN, IBUPROFEN (OTC) LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC) MICONAZOLE 7, MICONAZOLE NITRATE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) P AND L DEV LLC * P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC IBUPROFEN, IBUPROFEN (OTC) PACIFIC PHARMA * PACIFIC PHARMA TIMOLOL MALEATE, TIMOLOL MALEATE * PACIFIC PHARMA INC TIMOLOL MALEATE, TIMOLOL MALEATE PACIRA PHARMS INC * PACIRA PHARMACEUTICALS INC EXPAREL, BUPIVACAINE PADDOCK LABS LLC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 141 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PADDOCK LABORATORIES LLC ATOVAQUONE, ATOVAQUONE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE CYCLOSPORINE, CYCLOSPORINE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE REPAGLINIDE, REPAGLINIDE PADDOCK LLC * PADDOCK LABORATORIES LLC BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CALCIUM ACETATE, CALCIUM ACETATE CICLOPIROX, CICLOPIROX CLINDA-DERM, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE COMPRO, PROCHLORPERAZINE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350 MIDAMOR, AMILORIDE HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE NYSTOP, NYSTATIN PODOFILOX, PODOFILOX POTASSIUM CHLORIDE, POTASSIUM CHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TROSPIUM CHLORIDE, TROSPIUM CHLORIDE PALATIN TECHNOLOGIES * PALATIN TECHNOLOGIES INC VYLEESI (AUTOINJECTOR), ACETATE PANACEA BIOTEC LTD * PANACEA BIOTEC LTD PRASUGREL, PRASUGREL HYDROCHLORIDE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE TACROLIMUS, TACROLIMUS PAR FORM * PAR FORMULATIONS PRIVATE LTD DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE MAFENIDE ACETATE, MAFENIDE ACETATE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE PAR PHARM * PAR PHARMACEUTICAL EVEROLIMUS, EVEROLIMUS PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE TESTOSTERONE, TESTOSTERONE * PAR PHARMACEUTICAL INC ALPRAZOLAM, ALPRAZOLAM AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE CALCITONIN-SALMON, CALCITONIN SALMON CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CLOMIPHENE CITRATE, CLOMIPHENE CITRATE CLONAZEPAM, CLONAZEPAM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE, DOXYCYCLINE GLIPIZIDE, GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 142 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PAR PHARMACEUTICAL INC HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROXYUREA, HYDROXYUREA IBUPROFEN, IBUPROFEN (OTC) IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LAMOTRIGINE, LAMOTRIGINE MEGESTROL ACETATE, MEGESTROL ACETATE METRONIDAZOLE, METRONIDAZOLE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL NATEGLINIDE, NATEGLINIDE OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE OLANZAPINE, OLANZAPINE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE , OXANDROLONE , PIMOZIDE POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TORSEMIDE, TORSEMIDE TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE TRAVOPROST, TRAVOPROST URSODIOL, URSODIOL VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE PAR PHARM INC * PAR PHARMACEUTICAL INC ACCOLATE, ZAFIRLUKAST ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE AMBRISENTAN, AMBRISENTAN ASPIRIN AND DIPYRIDAMOLE, ASPIRIN BOSENTAN, BOSENTAN CHLORZOXAZONE, CHLORZOXAZONE , DEXLANSOPRAZOLE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DOFETILIDE, DOFETILIDE DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE ETHACRYNIC ACID, ETHACRYNIC ACID FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE PENICILLAMINE, PENICILLAMINE PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE PRAZIQUANTEL, PRAZIQUANTEL SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN DIHYDROCHLORIDE TOLCAPONE, TOLCAPONE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE VIGABATRIN, VIGABATRIN ZILEUTON, ZILEUTON ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE PAR STERILE PRODUCTS * PAR STERILE PRODUCTS LLC ADRENALIN, EPINEPHRINE ARGATROBAN, ARGATROBAN BREVITAL SODIUM, SODIUM BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE COLY-MYCIN M, COLISTIMETHATE SODIUM CORPHEDRA, EPHEDRINE SULFATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 143 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PAR STERILE PRODUCTS LLC DANTRIUM, DANTROLENE SODIUM DELESTROGEN, ESTRADIOL VALERATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE ETHACRYNATE SODIUM, ETHACRYNATE SODIUM FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE GANCICLOVIR SODIUM, GANCICLOVIR SODIUM KETALAR, KETAMINE HYDROCHLORIDE MICAFUNGIN, MICAFUNGIN SODIUM MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PITOCIN, OXYTOCIN TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE TREPROSTINIL, TREPROSTINIL TRIOSTAT, LIOTHYRONINE SODIUM VASOSTRICT, VASOPRESSIN PARAGON BIOTECK * PARAGON BIOTECK INC PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PARAPRO LLC * PARAPRO LLC NATROBA, SPINOSAD PARATEK PHARMS INC * PARATEK PHARMACEUTICALS INC NUZYRA, TOSYLATE PARKE DAVIS * PARKE DAVIS DIV WARNER LAMBERT CO CELONTIN, METHSUXIMIDE CEREBYX, FOSPHENYTOIN SODIUM NARDIL, PHENELZINE SULFATE ZARONTIN, ETHOSUXIMIDE PARKE-DAVIS * PARKE-DAVIS DIVISION OF PFIZER INC ZARONTIN, ETHOSUXIMIDE PERRIGO * PERRIGO CO DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC) MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC) * PERRIGO LLC DESLORATADINE, DESLORATADINE PERRIGO CO * PERRIGO CO OF TENESSEE INC CICLOPIROX, CICLOPIROX CLINDETS, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHROMYCIN, ERYTHROMYCIN STIE-CORT, HYDROCORTISONE PERRIGO CO TENNESSEE * PERRIGO CO TENNESSEE INC BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC BACITRACIN, BACITRACIN BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ZINC ERYTHROMYCIN, ERYTHROMYCIN GENTAMICIN SULFATE, GENTAMICIN SULFATE NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM PERRIGO ISRAEL * PERRIGO ISRAEL PHARMACEUTICALS LTD , AMMONIUM LACTATE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 144 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PERRIGO ISRAEL PHARMACEUTICALS LTD CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESOXIMETASONE, DESOXIMETASONE ECONAZOLE NITRATE, ECONAZOLE NITRATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GYNAZOLE-1, NITRATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE IMIQUIMOD, IMIQUIMOD KETOCONAZOLE, KETOCONAZOLE MESALAMINE, MESALAMINE MINOXIDIL, MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN NITROGLYCERIN, NITROGLYCERIN OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE PERMETHRIN, PERMETHRIN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE TERCONAZOLE, TERCONAZOLE TESTOSTERONE, TESTOSTERONE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE (OTC) PERRIGO NEW YORK * PERRIGO NEW YORK INC ACETAMINOPHEN, ACETAMINOPHEN (OTC) BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CENTANY, MUPIROCIN CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE ERYTHROMYCIN, ERYTHROMYCIN FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE GENTAMICIN SULFATE, GENTAMICIN SULFATE HYDROCORTISONE, HYDROCORTISONE MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE NYSTATIN, NYSTATIN PERMETHRIN, PERMETHRIN (OTC) , SELENIUM SULFIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE PERRIGO PHARMA INTL * PERRIGO PHARMA INTERNATIONAL DAC CLINDESSE, CLINDAMYCIN PHOSPHATE ENTOCORT EC, BUDESONIDE EVAMIST, ESTRADIOL LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE TAVABOROLE, TAVABOROLE TRETINOIN, TRETINOIN * PERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO LORATADINE, LORATADINE (OTC) PREVACID 24 HR, LANSOPRAZOLE (OTC) PERRIGO PHARMS CO * PERRIGO PHARMACEUTICALS CO CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE IBUPROFEN, IBUPROFEN NAPROXEN, NAPROXEN SCOPOLAMINE, SCOPOLAMINE PERRIGO R AND D * PERRIGO R AND D CO CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 145 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PERRIGO R AND D CO CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) FAMOTIDINE, CALCIUM CARBONATE, AND , CALCIUM CARBONATE (OTC) FAMOTIDINE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE (OTC) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC) GUAIFENESIN, GUAIFENESIN (OTC) IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC) IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC) IBUPROFEN, IBUPROFEN (OTC) LANSOPRAZOLE, LANSOPRAZOLE (OTC) LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) LEVONORGESTREL, LEVONORGESTREL (OTC) LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC) OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) PERRIGO UK FINCO * PERRIGO UK FINCO LTD PARTNERSHIP ACYCLOVIR, ACYCLOVIR ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DICLOFENAC SODIUM, DICLOFENAC SODIUM ESTRADIOL, ESTRADIOL FLURANDRENOLIDE, FLURANDRENOLIDE METRONIDAZOLE, METRONIDAZOLE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN SUMATRIPTAN, SUMATRIPTAN SUMATRIPTAN, SUMATRIPTAN SUCCINATE TESTOSTERONE, TESTOSTERONE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE PETNET * PETNET SOLUTIONS INC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 PF PRISM CV * PF PRISM CV BOSULIF, MONOHYDRATE CHANTIX, TARTRATE INLYTA, PRISTIQ, DESVENLAFAXINE SUCCINATE RAPAMUNE, SIROLIMUS TORISEL, TEMSIROLIMUS TYGACIL, TIGECYCLINE VFEND, VORICONAZOLE XALKORI, XELJANZ, TOFACITINIB CITRATE PFIZER * PFIZER CENTRAL RESEARCH

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 146 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PFIZER CENTRAL RESEARCH DIFLUCAN, FLUCONAZOLE ZITHROMAX, AZITHROMYCIN * PFIZER CHEMICALS DIV PFIZER INC DIFLUCAN, FLUCONAZOLE ZITHROMAX, AZITHROMYCIN * PFIZER INC ALDACTAZIDE, HYDROCHLOROTHIAZIDE ALDACTONE, SPIRONOLACTONE AROMASIN, EXEMESTANE ARTHROTEC, DICLOFENAC SODIUM AZULFIDINE EN-TABS, SULFASALAZINE AZULFIDINE, SULFASALAZINE CALAN SR, VERAPAMIL HYDROCHLORIDE CAVERJECT IMPULSE, ALPROSTADIL CAVERJECT, ALPROSTADIL CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLEOCIN T, CLINDAMYCIN PHOSPHATE CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE CLEOCIN, CLINDAMYCIN PHOSPHATE COLESTID, COLESTIPOL HYDROCHLORIDE CORVERT, IBUTILIDE FUMARATE CYKLOKAPRON, TRANEXAMIC ACID CYTOTEC, MISOPROSTOL DAURISMO, MALEATE DAYPRO, OXAPROZIN DEPO-ESTRADIOL, DEPO-MEDROL, METHYLPREDNISOLONE ACETATE DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE ESTRING, ESTRADIOL FLAGYL, METRONIDAZOLE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FRAGMIN, GLUCOTROL XL, GLIPIZIDE GLUCOTROL, GLIPIZIDE GLYNASE, GLYBURIDE GLYSET, MIGLITOL HALCION, TRIAZOLAM HEMABATE, CARBOPROST TROMETHAMINE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM IBRANCE, IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE LINCOCIN, HYDROCHLORIDE LOMOTIL, ATROPINE SULFATE LORBRENA, MEDROL, METHYLPREDNISOLONE MERREM, MEROPENEM MYCOBUTIN, RIFABUTIN NICOTROL, NICOTINE NORPACE CR, PHOSPHATE NORPACE, DISOPYRAMIDE PHOSPHATE OGEN 5, PREPIDIL, DINOPROSTONE PROCARDIA, NIFEDIPINE PROSTIN E2, DINOPROSTONE PROSTIN VR PEDIATRIC, ALPROSTADIL PROVERA, MEDROXYPROGESTERONE ACETATE SONATA, ZALEPLON SYNAREL, ACETATE TALZENNA, TOSYLATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 147 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PFIZER INC TESSALON, BENZONATATE TOVIAZ, FESOTERODINE FUMARATE UNASYN, AMPICILLIN SODIUM VIZIMPRO, XELJANZ XR, TOFACITINIB CITRATE XELJANZ, TOFACITINIB CITRATE ZINECARD, DEXRAZOXANE HYDROCHLORIDE ZITHROMAX, AZITHROMYCIN ZYVOX, LINEZOLID * PFIZER LABORATORIES DIV PFIZER INC FELDENE, PIROXICAM MINIPRESS, PRAZOSIN HYDROCHLORIDE PFIZERPEN, PENICILLIN G POTASSIUM PROCARDIA XL, NIFEDIPINE UNASYN, AMPICILLIN SODIUM VIBRAMYCIN, DOXYCYCLINE VIBRAMYCIN, DOXYCYCLINE CALCIUM VIBRAMYCIN, DOXYCYCLINE HYCLATE VISTARIL, HYDROXYZINE PAMOATE * PFIZER PHARMACEUTICALS PRODUCTION CORP LTD TIKOSYN, DOFETILIDE PFIZER INC * PFIZER INC CAMPTOSAR, IRINOTECAN HYDROCHLORIDE ELLENCE, EPIRUBICIN HYDROCHLORIDE NICOTROL, NICOTINE PFIZER PHARMS * PFIZER PHARMACEUTICALS LTD ACCUPRIL, QUINAPRIL HYDROCHLORIDE ACCURETIC, HYDROCHLOROTHIAZIDE LOPID, GEMFIBROZIL PHARM ASSOC * PHARMACEUTICAL ASSOC INC CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LORAZEPAM, LORAZEPAM PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE * PHARMACEUTICAL ASSOCIATES INC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ETHOSUXIMIDE, ETHOSUXIMIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LACTATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LACTULOSE, LACTULOSE LEVETIRACETAM, LEVETIRACETAM METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NYSTATIN, NYSTATIN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 148 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PHARMACEUTICAL ASSOCIATES INC PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE THEOPHYLLINE, THEOPHYLLINE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE VALPROIC ACID, VALPROIC ACID VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE PHARM SOURCING * PHARMACEUTICAL SOURCING PARTNERS INC MESALAMINE, MESALAMINE PHARMA LIFE * PHARMA LIFE SCIENCES LLC LEVETIRACETAM, LEVETIRACETAM RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE VALPROIC ACID, VALPROIC ACID PHARMA RES SOFTWARE * PHARMA RESEARCH SOFTWARE SOLUTION LLC POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PHARMACHEMIE BV * PHARMACHEMIE BV CARBOPLATIN, CARBOPLATIN CISPLATIN, CISPLATIN DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM PHARMACIA * PHARMACIA AND CO LLC CADUET, AMLODIPINE BESYLATE DILANTIN, PHENYTOIN PHARMACIA AND UPJOHN * PHARMACIA AND UPJOHN CO CORTEF, HYDROCORTISONE EMCYT, PHOSPHATE SODIUM R- 10, HYDROCHLORIDE SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACOSMOS AS * PHARMACOSMOS AS MONOFERRIC, FERRIC DERISOMALTOSE PHARMACYCLICS INC * PHARMACYCLICS INC IMBRUVICA, PHARMADAX INC * PHARMADAX INC ENTECAVIR, ENTECAVIR LEVETIRACETAM, LEVETIRACETAM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE PHARMALOGIC HLDGS * PHARMALOGIC HOLDINGS CORP FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 PHARMASCIENCE INC * PHARMASCIENCE INC BUSULFAN, BUSULFAN DECITABINE, DECITABINE GANCICLOVIR SODIUM, GANCICLOVIR SODIUM PHARMATHEN * PHARMATHEN SA DIMETHYL FUMARATE, DIMETHYL FUMARATE PHARMAXIS LTD * PHARMAXIS LTD ARIDOL KIT, MANNITOL PHOTOCURE ASA

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 149 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PHOTOCURE ASA CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE PIERRE FABRE DERMA * PIERRE FABRE DERMATOLOGIE HEMANGEOL, PROPRANOLOL HYDROCHLORIDE PIERREL * PIERREL S.P.A. ORABLOC, ARTICAINE HYDROCHLORIDE PINNACLE BIOLGS * PINNACLE BIOLOGICS INC PHOTOFRIN, PIRAMAL CRITICAL * PIRAMAL CRITICAL CARE INC GABLOFEN, BACLOFEN GLYCOPYRROLATE, GLYCOPYRROLATE ISOFLURANE, ISOFLURANE MITIGO, MORPHINE SULFATE OXACILLIN SODIUM, OXACILLIN SODIUM ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SOJOURN, SEVOFLURANE * PIRAMAL CRITICAL CARE LTD LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM PIRAMAL ENT * PIRAMAL ENTERPRISES LTD ISOFLURANE, ISOFLURANE PIRAMAL HLTHCARE UK * PIRAMAL HEALTHCARE UK LTD CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CLOBAZAM, CLOBAZAM DEFERASIROX, DEFERASIROX LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE TETRABENAZINE, TETRABENAZINE PLD ACQUISITIONS * PLD ACQUISITIONS LLC DBA AVEMA PHARMA SOLUTIONS CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC) PLD ACQUISITIONS LLC * PLD ACQUISITIONS LLC LORATADINE, LORATADINE (OTC) ZOLMITRIPTAN, ZOLMITRIPTAN PLIVA * PLIVA INC AZITHROMYCIN, AZITHROMYCIN BENZTROPINE MESYLATE, BENZTROPINE MESYLATE CIMETIDINE, CIMETIDINE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM PLIVA HRVATSKA DOO * PLIVA HRVATSKA DOO DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE PLIVA PHARM IND * PLIVA INC TORSEMIDE, TORSEMIDE PLX PHARMA * PLX PHARMA INC VAZALORE, ASPIRIN (OTC) POHL BOSKAMP * POHL BOSKAMP

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 150 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * POHL BOSKAMP NITROLINGUAL PUMPSPRAY, NITROGLYCERIN POLYGEN PHARMS * POLYGEN PHARMACEUTICALS INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE POLYMEDICA * POLYMEDICA INDUSTRIES INC NEOPAP, ACETAMINOPHEN (OTC) POWDER PHARMS * POWDER PHARMACEUTICALS INC ZINGO, LIDOCAINE HYDROCHLORIDE PRAGMA * PRAGMA PHARMACEUTICALS LLC KEFLEX, CEPHALEXIN PRASCO * PRASCO LLC DBA EPLERENONE, EPLERENONE PRAXAIR DISTRIBUTION * PRAXAIR DISTRIBUTION INC NOXIVENT, NITRIC OXIDE PRAXGEN * PRAXGEN PHARMACEUTICALS LLC DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE LINCOMYCIN HYDROCHLORIDE, LINCOMYCIN HYDROCHLORIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE RANOLAZINE, RANOLAZINE PRECISION DERMAT * PRECISION INC LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE LOCOID, HYDROCORTISONE BUTYRATE PRECISION DOSE INC * PRECISION DOSE INC MESYLATE, PHENTOLAMINE MESYLATE PRECISION NUCLEAR * PRECISION NUCLEAR LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 PRIMUS PHARMS * PRIMUS PHARMACEUTICALS INC IMPOYZ, CLOBETASOL PROPIONATE SERNIVO, BETAMETHASONE DIPROPIONATE PRINSTON INC * PRINSTON PHARMACEUTICAL INC AMPHETAMINE SULFATE, AMPHETAMINE SULFATE ARIPIPRAZOLE, ARIPIPRAZOLE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CAPTOPRIL, CAPTOPRIL CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 151 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PRINSTON PHARMACEUTICAL INC DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENTECAVIR, ENTECAVIR ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FENOFIBRATE, FENOFIBRATE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GLIMEPIRIDE, GLIMEPIRIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LEVETIRACETAM, LEVETIRACETAM LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE NEVIRAPINE, NEVIRAPINE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PAROXETINE MESYLATE, PAROXETINE MESYLATE PAROXETINE, PAROXETINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE RISPERIDONE, RISPERIDONE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN TEMAZEPAM, TEMAZEPAM VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE VALSARTAN, VALSARTAN VORICONAZOLE, VORICONAZOLE PROF DSPLS * PROFESSIONAL DISPOSABLES INC PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC) PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC) PROGENICS PHARMS INC * PROGENICS PHARMACEUTICALS INC AZEDRA, IOBENGUANE I-131 PYLARIFY, PIFLUFOLASTAT F-18 PROVELL * PROVELL PHARMACEUTICALS LLC EUTHYROX, LEVOTHYROXINE SODIUM ** PROVENSIS * PROVENSIS LTD VARITHENA, POLIDOCANOL PROVEPHARM SAS * PROVEPHARM SAS DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PROVAYBLUE, BLUE TRANEXAMIC ACID, TRANEXAMIC ACID PTC THERAP * PTC THERAPEUTICS INC EMFLAZA, PULMOFLOW INC * PULMOFLOW INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 152 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P ** * PULMOFLOW INC KITABIS PAK, TOBRAMYCIN PUMA BIOTECH * PUMA BIOTECHNOLOGY INC NERLYNX, MALEATE PUNISKA * PUNISKA HEALTHCARE PRIVATE LTD GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID PURACAP PHARM * PURACAP PHARMACEUTICAL LLC MELOXICAM, MELOXICAM PURACAP PHARM LLC * PURACAP PHARMACEUTICAL LLC BENZONATATE, BENZONATATE ERGOCALCIFEROL, ERGOCALCIFEROL ETHOSUXIMIDE, ETHOSUXIMIDE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PURDUE * PURDUE GMP CENTER LLC SEROMYCIN, LP * PURDUE PHARMA LP ADHANSIA XR, METHYLPHENIDATE HYDROCHLORIDE BUTRANS, BUPRENORPHINE HYSINGLA ER, HYDROCODONE BITARTRATE MS CONTIN, MORPHINE SULFATE OXYCONTIN, OXYCODONE HYDROCHLORIDE

** Q ** Q BIOMED * Q BIOMED INC METASTRON, CHLORIDE SR-89 STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89 QED THERAP * QED THERAPEUTICS INC TRUSELTIQ, PHOSPHATE QILU * QILU PHARMACEUTICAL CO LTD ABIRATERONE ACETATE, ABIRATERONE ACETATE CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CEFTRIAXONE, CEFTRIAXONE SODIUM DECITABINE, DECITABINE EXEMESTANE, EXEMESTANE FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TADALAFIL, TADALAFIL TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE QINGDAO BAHEAL PHARM * QINGDAO BAHEAL PHARMACEUTICAL CO LTD BENZONATATE, BENZONATATE CELECOXIB, CELECOXIB DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 153 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Q ** * QINGDAO BAHEAL PHARMACEUTICAL CO LTD FOLIC ACID, FOLIC ACID METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE QOL MEDCL * QOL MEDICAL LLC ETHAMOLIN, ETHANOLAMINE OLEATE QUAGEN * QUAGEN PHARMACEUTICALS LLC ALBUTEROL SULFATE, ALBUTEROL SULFATE CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE LIDOCAINE, LIDOCAINE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPYLTHIOURACIL, PROPYLTHIOURACIL TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE QUEEN HAMAMATSU PET * QUEEN HAMAMATSU PET IMAGING CENTER FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

** R ** R-PHARM US LLC * R-PHARM US LLC IXEMPRA KIT, RADIOMEDIX * RADIOMEDIX INC DETECTNET, COPPER DOTATATE CU-64 RADIUS HEALTH INC * RADIUS HEALTH INC TYMLOS, RANBAXY * RANBAXY SIGNATURE LLC RIOMET, METFORMIN HYDROCHLORIDE RB HLTH * RB HEALTH US LLC DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC) MUCINEX D, GUAIFENESIN (OTC) MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC) MUCINEX, GUAIFENESIN (OTC) RECIP * RECIP AB THYROSAFE, POTASSIUM IODIDE (OTC) RECORDATI RARE * RECORDATI RARE DISEASES INC CARBAGLU, CHEMET, SUCCIMER COSMEGEN, DACTINOMYCIN CYSTADROPS, CYSTEAMINE HYDROCHLORIDE DESOXYN, METHAMPHETAMINE HYDROCHLORIDE ISTURISA, PHOSPHATE NEOPROFEN, IBUPROFEN SIGNIFOR LAR KIT, PAMOATE SIGNIFOR, PASIREOTIDE DIASPARTATE TRANXENE, CLORAZEPATE DIPOTASSIUM RECRO GAINESVILLE * RECRO GAINESVILLE LLC VERELAN PM, VERAPAMIL HYDROCHLORIDE VERELAN, VERAPAMIL HYDROCHLORIDE ZOHYDRO ER, HYDROCODONE BITARTRATE REDHILL * REDHILL BIOPHARMA INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 154 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R ** * REDHILL BIOPHARMA INC AEMCOLO, SODIUM MOVANTIK, NALOXEGOL OXALATE * REDHILL BIOPHARMA LTD TALICIA, AMOXICILLIN RELIANCE LIFE * RELIANCE LIFE SCIENCES PVT LTD CAPECITABINE, CAPECITABINE REMPEX * REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC MINOCIN, MINOCYCLINE HYDROCHLORIDE VABOMERE, MEROPENEM RENATA * RENATA LTD RISPERIDONE, RISPERIDONE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM RENEW PHARMS * RENEW PHARMACEUTICALS LTD INDOCYANINE GREEN, INDOCYANINE GREEN RESILIA PHARMS * RESILIA PHARMACEUTICALS INC ECOZA, ECONAZOLE NITRATE REYOUNG * REYOUNG CORPORATION SILDENAFIL CITRATE, SILDENAFIL CITRATE RHODES PHARMS * RHODES PHARMACEUTICALS LP APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DILAUDID, HYDROMORPHONE HYDROCHLORIDE FENOFIBRATE (MICRONIZED), FENOFIBRATE FENOFIBRATE, FENOFIBRATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LIDOCAINE, LIDOCAINE MORPHINE SULFATE, MORPHINE SULFATE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE THEOPHYLLINE, THEOPHYLLINE RHYTHM * RHYTHM PHARMACEUTICALS INC IMCIVREE, ACETATE RICONPHARMA LLC * RICONPHARMA LLC BETAMETHASONE VALERATE, BETAMETHASONE VALERATE CHLORTHALIDONE, CHLORTHALIDONE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE METHENAMINE HIPPURATE, METHENAMINE HIPPURATE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE SCOPOLAMINE, SCOPOLAMINE TRIAZOLAM, TRIAZOLAM RIGEL PHARMS INC * RIGEL PHARMACEUTICALS INC TAVALISSE, FOSTAMATINIB DISODIUM RISING * RISING PHARMA HOLDING INC DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FLUNISOLIDE, FLUNISOLIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 155 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R ** * RISING PHARMA HOLDINGS INC ABIRATERONE ACETATE, ABIRATERONE ACETATE ACETIC ACID, ACETIC ACID, GLACIAL ALBUTEROL SULFATE, ALBUTEROL SULFATE ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE AZATHIOPRINE, AZATHIOPRINE BUDESONIDE, BUDESONIDE BUMETANIDE, BUMETANIDE CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE CICLOPIROX, CICLOPIROX CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CROMOLYN SODIUM, CROMOLYN SODIUM CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DAPSONE, DAPSONE DESOXIMETASONE, DESOXIMETASONE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIFLORASONE DIACETATE, DIFLORASONE DIACETATE DOXERCALCIFEROL, DOXERCALCIFEROL GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCORTISONE, HYDROCORTISONE LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN LEVOCARNITINE, LEVOCARNITINE LEVOFLOXACIN, LEVOFLOXACIN METAXALONE, METAXALONE METHIMAZOLE, METHIMAZOLE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE NATEGLINIDE, NATEGLINIDE , NITAZOXANIDE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN PARICALCITOL, PARICALCITOL PERPHENAZINE, PERPHENAZINE POTASSIUM CITRATE, POTASSIUM CITRATE PREGABALIN, PREGABALIN PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RISPERIDONE, RISPERIDONE SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE SULFAMYLON, MAFENIDE ACETATE TEMOZOLOMIDE, TEMOZOLOMIDE TOREMIFENE CITRATE, TOREMIFENE CITRATE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZILEUTON, ZILEUTON * RISING PHARMACEUTICALS URSODIOL, URSODIOL RK PHARMA * RK PHARMA INC CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE MITOMYCIN, MITOMYCIN MYCOPHENOLIC ACID, MYCOPHENOLIC ACID PALIPERIDONE, PALIPERIDONE ROCHE PALO * ROCHE PALO ALTO LLC CELLCEPT, MYCOPHENOLATE MOFETIL CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCKWELL MEDICAL INC * ROCKWELL MEDICAL INC TRIFERIC AVNU, FERRIC PYROPHOSPHATE CITRATE TRIFERIC, FERRIC PYROPHOSPHATE CITRATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 156 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R ** ROMARK * ROMARK LABORATORIES ALINIA, NITAZOXANIDE ROUSES POINT PHARMS * ROUSES POINT PHARMACEUTICALS LLC LEVETIRACETAM, LEVETIRACETAM ROXANE * ROXANE LABORATORIES INC METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE RUBICON * RUBICON RESEARCH PRIVATE LTD AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE BACLOFEN, BACLOFEN BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CARVEDILOL, CARVEDILOL CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM GABAPENTIN, GABAPENTIN LAMOTRIGINE, LAMOTRIGINE LORATADINE, LORATADINE (OTC) METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE NITROGLYCERIN, NITROGLYCERIN OXCARBAZEPINE, OXCARBAZEPINE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE RVL PHARMS * RVL PHARMACEUTICALS INC UPNEEQ, OXYMETAZOLINE HYDROCHLORIDE

** S ** SAGE PRODS * SAGE PRODUCTS INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC) SAGE THERAP * SAGE THERAPEUTICS INC ZULRESSO, BREXANOLONE SAGENT PHARMS * SAGENT PHARMACEUTICALS INC CAFFEINE CITRATE, CAFFEINE CITRATE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE FLUMAZENIL, FLUMAZENIL HALOPERIDOL, HALOPERIDOL LACTATE HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM HEPARIN SODIUM, HEPARIN SODIUM LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEVETIRACETAM, LEVETIRACETAM NAFCILLIN SODIUM, NAFCILLIN SODIUM ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXACILLIN SODIUM, OXACILLIN SODIUM TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE SAGENT PHARMS INC * SAGENT PHARMACEUTICALS INC ACETYLCYSTEINE, ACETYLCYSTEINE AMIKACIN SULFATE, AMIKACIN SULFATE AMPICILLIN SODIUM, AMPICILLIN SODIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 157 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SAGENT PHARMACEUTICALS INC CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM DAPTOMYCIN, DAPTOMYCIN DECITABINE, DECITABINE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE EPTIFIBATIDE, EPTIFIBATIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FLUOROURACIL, FLUOROURACIL FULVESTRANT, FULVESTRANT GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLYDO, LIDOCAINE HYDROCHLORIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LINEZOLID, LINEZOLID MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MESNA, MESNA METHOCARBAMOL, METHOCARBAMOL METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OXYTOCIN, OXYTOCIN PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PROPOFOL, PROPOFOL ROCURONIUM BROMIDE, ROCURONIUM BROMIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID SALIX * INC FENOGLIDE, FENOFIBRATE PLENVU, ASCORBIC ACID RELISTOR, METHYLNALTREXONE BROMIDE TRULANCE, PLECANATIDE UCERIS, BUDESONIDE ZEGERID, OMEPRAZOLE SALIX PHARMS * SALIX PHARMACEUTICALS INC ANUSOL HC, HYDROCORTISONE DIURIL, CHLOROTHIAZIDE MOVIPREP, ASCORBIC ACID OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS RELISTOR, METHYLNALTREXONE BROMIDE XIFAXAN, SAMSON MEDCL * SAMSON MEDICAL TECHNOLOGIES LLC CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM CEFTRIAXONE, CEFTRIAXONE SODIUM VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 158 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** SANDOZ * SANDOZ DOCETAXEL, DOCETAXEL * SANDOZ INC ALPRAZOLAM, ALPRAZOLAM AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM AMPICILLIN SODIUM, AMPICILLIN SODIUM AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE APREPITANT, APREPITANT ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BUMETANIDE, BUMETANIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFERGOT, CAFFEINE CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN CARVEDILOL, CARVEDILOL CEFAZOLIN SODIUM, CEFAZOLIN SODIUM CEFDINIR, CEFDINIR CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL CEFPROZIL, CEFPROZIL CEFTRIAXONE, CEFTRIAXONE SODIUM CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CLARITHROMYCIN, CLARITHROMYCIN CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONAZEPAM, CLONAZEPAM COSYNTROPIN, COSYNTROPIN CYCLOSPORINE, CYCLOSPORINE DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE DESLORATADINE, DESLORATADINE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM EPLERENONE, EPLERENONE ETODOLAC, ETODOLAC FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM FUROSEMIDE, FUROSEMIDE GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE, GLIPIZIDE HALOPERIDOL, HALOPERIDOL HEPARIN SODIUM, HEPARIN SODIUM HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE INDOMETHACIN, INDOMETHACIN IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE ITRACONAZOLE, ITRACONAZOLE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LANSOPRAZOLE, LANSOPRAZOLE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVOFLOXACIN, LEVOFLOXACIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 159 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SANDOZ INC LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOVASTATIN, LOVASTATIN MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHAZOLAMIDE, METHAZOLAMIDE METHYLPREDNISOLONE, METHYLPREDNISOLONE METOLAZONE, METOLAZONE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NADOLOL, NADOLOL NAFCILLIN SODIUM, NAFCILLIN SODIUM NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN NIZATIDINE, NIZATIDINE OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE OMEPRAZOLE, OMEPRAZOLE ONDANSETRON, ONDANSETRON ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXALIPLATIN, OXALIPLATIN OXAPROZIN, OXAPROZIN OXAZEPAM, OXAZEPAM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM PENICILLIN G SODIUM, PENICILLIN G SODIUM PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM PERPHENAZINE, PERPHENAZINE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUINIDINE SULFATE, QUINIDINE SULFATE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIBAVIRIN, RIBAVIRIN RIFAMPIN, RIFAMPIN RISPERIDONE, RISPERIDONE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SULFADIAZINE, SULFADIAZINE TACROLIMUS, TACROLIMUS TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TEMAZEPAM, TEMAZEPAM TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE SANDOZ CANADA INC * SANDOZ CANADA INC INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID INFUVITE PEDIATRIC, ASCORBIC ACID SANDOZ INC * SANDOZ INC ACETAMINOPHEN, ACETAMINOPHEN ALBUTEROL SULFATE, ALBUTEROL SULFATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN ANECTINE, SUCCINYLCHOLINE CHLORIDE ANGIOMAX, BIVALIRUDIN ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 160 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SANDOZ INC ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BETOPTIC, BETAXOLOL HYDROCHLORIDE BIMATOPROST, BIMATOPROST BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE BUDESONIDE, BUDESONIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBOPLATIN, CARBOPLATIN HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE CEFTRIAXONE, CEFTRIAXONE SODIUM CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE CROMOLYN SODIUM, CROMOLYN SODIUM CYANOCOBALAMIN, CYANOCOBALAMIN DECITABINE, DECITABINE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIGOXIN, DIGOXIN DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE DOXERCALCIFEROL, DOXERCALCIFEROL ENALAPRIL MALEATE, ENALAPRIL MALEATE ENOXAPARIN SODIUM, ENOXAPARIN SODIUM EPHEDRINE SULFATE, EPHEDRINE SULFATE EZETIMIBE, EZETIMIBE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FERUMOXYTOL, FERUMOXYTOL FLUMAZENIL, FLUMAZENIL FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FULVESTRANT, FULVESTRANT GATIFLOXACIN, GATIFLOXACIN GENTAMICIN SULFATE, GENTAMICIN SULFATE GLATOPA, GLATIRAMER ACETATE GLYCOPYRROLATE, GLYCOPYRROLATE GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE ISONIAZID, ISONIAZID KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN LATANOPROST, LATANOPROST LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM LINEZOLID, LINEZOLID MAXITROL, DEXAMETHASONE MESALAMINE, MESALAMINE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METOPROLOL TARTRATE, METOPROLOL TARTRATE MONTELUKAST SODIUM, MONTELUKAST SODIUM MYDRIACYL, TROPICAMIDE NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE NEVIRAPINE, NEVIRAPINE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PARICALCITOL, PARICALCITOL PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 161 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SANDOZ INC PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE QOLIANA, BRIMONIDINE TARTRATE RASAGILINE MESYLATE, RASAGILINE MESYLATE REGONOL, PYRIDOSTIGMINE BROMIDE ROCURONIUM BROMIDE, ROCURONIUM BROMIDE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SILODOSIN, SILODOSIN SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TELMISARTAN, TELMISARTAN TERIFLUNOMIDE, TERIFLUNOMIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TIGECYCLINE, TIGECYCLINE TIMOLOL MALEATE, TIMOLOL MALEATE TOBREX, TOBRAMYCIN TREPROSTINIL, TREPROSTINIL TRIFLURIDINE, TRIFLURIDINE TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE * SANOFI GENZYME HECTOROL, DOXERCALCIFEROL RENVELA, SEVELAMER CARBONATE SANOFI AVENTIS US * SANOFI AVENTIS US INC JEVTANA KIT, * SANOFI AVENTIS US LLC ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC) AMARYL, GLIMEPIRIDE AMBIEN CR, ZOLPIDEM TARTRATE AMBIEN, ZOLPIDEM TARTRATE ARAVA, LEFLUNOMIDE AUBAGIO, TERIFLUNOMIDE AVALIDE, HYDROCHLOROTHIAZIDE AVAPRO, IRBESARTAN CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) DIABETA, GLYBURIDE ELOXATIN, OXALIPLATIN FERRLECIT, FERRIC OXYHYDROXIDE FLOMAX, TAMSULOSIN HYDROCHLORIDE GAVISCON, ALUMINUM HYDROXIDE (OTC) LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM LOVENOX, ENOXAPARIN SODIUM MULTAQ, HYDROCHLORIDE NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC) NICODERM CQ, NICOTINE (OTC) PLAVIX, CLOPIDOGREL BISULFATE PRIFTIN, PRIMAQUINE, PRIMAQUINE PHOSPHATE RIFADIN, RIFAMPIN TAXOTERE, DOCETAXEL XYZAL ALLERGY 24HR, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC) SANTARUS INC * SANTARUS INC GLUMETZA, METFORMIN HYDROCHLORIDE SANTEN * SANTEN INC VERKAZIA, CYCLOSPORINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 162 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** SAOL THERAPS RES LTD * SAOL THERAPEUTICS RESEARCH LTD LIORESAL, BACLOFEN SAPTALIS PHARMS * SAPTALIS PHARMACEUTICALS LLC ACETIC ACID, ACETIC ACID, GLACIAL CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE ERYTHRA-DERM, ERYTHROMYCIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE SAREPTA THERAPS INC * INC AMONDYS 45, CASIMERSEN EXONDYS 51, ETEPLIRSEN VYONDYS 53, GOLODIRSEN SARFE PHARMS * SARFEZ PHARMACEUTICALS INC SOAANZ, TORSEMIDE SAVIOR LIFETEC CORP * SAVIOR LIFETEC CORP ERTAPENEM SODIUM, ERTAPENEM SODIUM MEROPENEM, MEROPENEM SAWAI USA * SAWAI USA INC PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM SB PHARMCO * SB PHARMCO INC AVANDIA, MALEATE SCHERING * SCHERING CORP NOXAFIL, POSACONAZOLE SCIECURE PHARMA INC * SCIECURE PHARMA INC BUDESONIDE, BUDESONIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE SCIEGEN PHARMS INC * SCIEGEN PHARMACEUTICALS INC AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CARISOPRODOL, CARISOPRODOL CELECOXIB, CELECOXIB CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DROXIDOPA, DROXIDOPA ETHACRYNIC ACID, ETHACRYNIC ACID EZETIMIBE, EZETIMIBE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE IRBESARTAN, IRBESARTAN LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE METAXALONE, METAXALONE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NABUMETONE, NABUMETONE NAPROXEN SODIUM, NAPROXEN SODIUM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 163 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SCIEGEN PHARMACEUTICALS INC NAPROXEN, NAPROXEN OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PREGABALIN, PREGABALIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RANOLAZINE, RANOLAZINE SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE SCILEX PHARMS INC * SCILEX PHARMACEUTICALS ZTLIDO, LIDOCAINE SCINOPHARM * SCINOPHARM TAIWAN LTD FONDAPARINUX SODIUM, FONDAPARINUX SODIUM SCYNEXIS * SCYNEXIS INC BREXAFEMME, CITRATE * SEAGEN INC TUKYSA, SEBELA IRELAND LTD * SEBELA IRELAND LTD BRISDELLE, PAROXETINE MESYLATE IMURAN, AZATHIOPRINE LOTRONEX, ALOSETRON HYDROCHLORIDE MICORT-HC, HYDROCORTISONE ACETATE MOTOFEN, ATROPINE SULFATE NAFTIN, HYDROCHLORIDE PEXEVA, PAROXETINE MESYLATE PRAMOSONE, HYDROCORTISONE ACETATE RIDAURA, AURANOFIN SECAN PHARMS * SECAN PHARMACEUTICALS INC LEVETIRACETAM, LEVETIRACETAM SECURA * SECURA BIO INC COPIKTRA, FARYDAK, LACTATE SEDOR PHARMS LLC * SEDOR PHARMACEUTICALS LLC SESQUIENT, FOSPHENYTOIN SODIUM SENTYNL THERAPS INC * SENTYNL THERAPEUTICS INC LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE SEPTODONT * SEPTODONT INC BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE SEPTODONT HOLDING * SEPTODONT HOLDING SAS ORAVERSE, PHENTOLAMINE MESYLATE SEPTODONT INC * SEPTODONT INC LIDOCAINE, LIDOCAINE PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE SERB SA * SERB SA CYANOKIT, HYDROXOCOBALAMIN SERVIER * SERVIER PHARMACEUTICALS LLC TIBSOVO,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 164 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** SETON PHARM * SETON PHARMACEUTICAL LLC PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE SETON PHARMS * SETON PHARMACEUTICALS LLC MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE SHANDONG * SHANDONG NEW TIME PHARMACEUTICAL CO LTD ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SHANDONG XINHUA * SHANDONG XINHUA PHARMACEUTICAL CO LTD IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) SHANGHAI HENGRUI * SHANGHAI HENGRUI PHARMACEUTICAL CO LTD DESFLURANE, DESFLURANE SEVOFLURANE, SEVOFLURANE SHENZHEN TECHDOW * SHENZHEN TECHDOW PHARMACEUTICAL CO LTD HEPARIN SODIUM, HEPARIN SODIUM SHERTECH LABS LLC * SHERTECH LABORATORIES LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 SHIELD TX * SHIELD TX UK LTD ACCRUFER, SHILPA * SHILPA MEDICARE LTD BUSULFAN, BUSULFAN CAPECITABINE, CAPECITABINE DOCETAXEL, DOCETAXEL ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE IMATINIB MESYLATE, IMATINIB MESYLATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE SHILPA MEDICARE * SHILPA MEDICARE LTD AZACITIDINE, AZACITIDINE SHIONOGI INC * SHIONOGI INC FETROJA, CEFIDEROCOL SULFATE TOSYLATE MULPLETA, LUSUTROMBOPAG SHIRE ORPHAN THERAP * SHIRE ORPHAN THERAPIES LLC FIRAZYR, ICATIBANT ACETATE SIDMAK LABS INDIA * SIDMAK LABORATORIES INDIA PVT LTD MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE SIGA TECHNOLOGIES * SIGA TECHNOLOGIES INC TPOXX, TECOVIRIMAT SIGMAPHARM LABS LLC * SIGMAPHARM LABORATORIES LLC ACITRETIN, ACITRETIN ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL AMBRISENTAN, AMBRISENTAN AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE ASENAPINE MALEATE, ASENAPINE MALEATE DISULFIRAM, DISULFIRAM DOFETILIDE, DOFETILIDE ERGOCALCIFEROL, ERGOCALCIFEROL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 165 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SIGMAPHARM LABORATORIES LLC FLUCYTOSINE, FLUCYTOSINE GRISEOFULVIN, GRISEOFULVIN, MICROSIZE GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NITROGLYCERIN, NITROGLYCERIN POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE TICAGRELOR, TICAGRELOR SINOTHERAPEUTICS INC * SINOTHERAPEUTICS INC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE POSACONAZOLE, POSACONAZOLE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE SK LIFE * SK LIFE SCIENCE INC XCOPRI, SKINMEDICA * SKINMEDICA INC VANIQA, HYDROCHLORIDE SKYEPHARMA AG * SKYEPHARMA AG TRIGLIDE, FENOFIBRATE SLATE * SLATE RUN PHARMACEUTICALS LLC CILOSTAZOL, CILOSTAZOL DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE METHOCARBAMOL, METHOCARBAMOL PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE SLAYBACK PHARMA LLC * SLAYBACK PHARMA LLC DEOXYCHOLIC ACID, DEOXYCHOLIC ACID DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE ICATIBANT ACETATE, ICATIBANT ACETATE MERZEE, ETHINYL ESTRADIOL SMITHKLINE BEECHAM * SMITHKLINE BEECHAM (CORK) LTD IRELAND COREG CR, CARVEDILOL PHOSPHATE COREG, CARVEDILOL SOAPCO * SOAPCO INC BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC) SOFGEN PHARMS * SOFGEN PHARMACEUTICALS NIMODIPINE, NIMODIPINE * SOFGEN PHARMACEUTICALS LLC IBUPROFEN, IBUPROFEN (OTC) OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS PROGESTERONE, PROGESTERONE SOFIE * SOFIE CO DBA SOFIE AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 * SOFIE CO DBA SOFIE (FKA ZEVACOR PHARMA INC) AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 SOLARIS PHARMA CORP * SOLARIS PHARMA CORP ACYCLOVIR, ACYCLOVIR CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 166 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SOLARIS PHARMA CORP FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE SOMERSET * SOMERSET PHARMACEUTICALS INC EMSAM, SELEGILINE * SOMERSET THERAPEUTICS LLC CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE LATANOPROST, LATANOPROST SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE SOMERSET THERAPS LLC * SOMERSET THERAPEUTICS LLC AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BIMATOPROST, BIMATOPROST BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE CYANOCOBALAMIN, CYANOCOBALAMIN DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE GLYCOPYRROLATE, GLYCOPYRROLATE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE METHOCARBAMOL, METHOCARBAMOL NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TOBRAMYCIN, TOBRAMYCIN TROPICAMIDE, TROPICAMIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE SOMMER PHARMS II LLC * SOMMER PHARMACEUTICALS II LLC TECHNETIUM TC99M MERTIATIDE KIT, TECHNETIUM TC-99M MERTIATIDE KIT SPECGX LLC * SPECGX LLC ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN AMPHETAMINE SULFATE, AMPHETAMINE SULFATE ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE ANEXSIA 5/325, ACETAMINOPHEN ANEXSIA 7.5/325, ACETAMINOPHEN BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE FENTANYL CITRATE, FENTANYL CITRATE FENTANYL-100, FENTANYL FENTANYL-12, FENTANYL FENTANYL-25, FENTANYL FENTANYL-37, FENTANYL FENTANYL-50, FENTANYL FENTANYL-62, FENTANYL FENTANYL-75, FENTANYL HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METHADOSE, METHADONE HYDROCHLORIDE METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE METHYLIN, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 167 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SPECGX LLC MORPHINE SULFATE, MORPHINE SULFATE NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OXYCET, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE RESTORIL, TEMAZEPAM ROXICODONE, OXYCODONE HYDROCHLORIDE TOFRANIL, IMIPRAMINE HYDROCHLORIDE SPECTRA MDCL DEVICES * SPECTRA MEDICAL DEVICES INC LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE SPIL * INDUSTRIES LTD KAPSPARGO SPRINKLE, METOPROLOL SUCCINATE NIFEDIPINE, NIFEDIPINE OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC) SPROUT PHARMS * SPROUT PHARMACEUTICALS INC ADDYI, SQUARE PHARMS LTD * SQUARE PHARMACEUTICALS LTD ACYCLOVIR, ACYCLOVIR VALSARTAN, VALSARTAN ST RENATUS * ST RENATUS LLC KOVANAZE, OXYMETAZOLINE HYDROCHLORIDE STAND HOMEOPATH * STANDARD HOMEOPATHIC CO IVY BLOCK, BENTOQUATAM (OTC) STASON PHARMS * STASON PHARMACEUTICALS INC PURINETHOL, MERCAPTOPURINE STI PHARMA LLC * STI PHARMA LLC ARSENIC TRIOXIDE, ARSENIC TRIOXIDE CARMUSTINE, CARMUSTINE CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE THIOTEPA, THIOTEPA TRIACIN-C, CODEINE PHOSPHATE STIEFEL * INC DUAC, BENZOYL PEROXIDE STIEFEL LABS INC * STIEFEL LABORATORIES INC SORIATANE, ACITRETIN STRIDES PHARMA * STRIDES PHARMA GLOBAL PTE LTD ABACAVIR SULFATE, ABACAVIR SULFATE ACARBOSE, ACARBOSE ACETAZOLAMIDE, ACETAZOLAMIDE ALBENDAZOLE, ALBENDAZOLE AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BENZONATATE, BENZONATATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN CALCITRIOL, CALCITRIOL

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 168 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * STRIDES PHARMA GLOBAL PTE LTD CARISOPRODOL, CARISOPRODOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CLARITHROMYCIN, CLARITHROMYCIN CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DUTASTERIDE, DUTASTERIDE EFAVIRENZ, EFAVIRENZ EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ERGOCALCIFEROL, ERGOCALCIFEROL ETHACRYNIC ACID, ETHACRYNIC ACID ETHOSUXIMIDE, ETHOSUXIMIDE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE GABAPENTIN, GABAPENTIN HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE HYDROCORTISONE, HYDROCORTISONE IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC) IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) ITRACONAZOLE, ITRACONAZOLE KETOCONAZOLE, KETOCONAZOLE LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE LAMIVUDINE, LAMIVUDINE LIDOCAINE, LIDOCAINE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MELOXICAM, MELOXICAM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METHOXSALEN, METHOXSALEN METRONIDAZOLE, METRONIDAZOLE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NEVIRAPINE, NEVIRAPINE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL PIROXICAM, PIROXICAM POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC) POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PREDNISONE, PREDNISONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE ROFLUMILAST, ROFLUMILAST SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TACROLIMUS, TACROLIMUS TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE URSODIOL, URSODIOL VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE STRONGBRIDGE US * STRONGBRIDGE US INC KEVEYIS, DICHLORPHENAMIDE SUCAMPO PHARMA LLC * SUCAMPO PHARMA AMERICAS LLC AMITIZA, LUBIPROSTONE SUN PHARM * SUN PHARMACEUTICAL INDUSTRIES LTD ABSORICA LD, ISOTRETINOIN ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 169 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SUN PHARMACEUTICAL INDUSTRIES LTD ALPRAZOLAM, ALPRAZOLAM AMBRISENTAN, AMBRISENTAN AMIFOSTINE, AMIFOSTINE ASPIRIN AND DIPYRIDAMOLE, ASPIRIN AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BOSENTAN, BOSENTAN BUDESONIDE, BUDESONIDE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAFFEINE CITRATE, CAFFEINE CITRATE CALCITRIOL, CALCITRIOL CAPECITABINE, CAPECITABINE CARBIDOPA AND LEVODOPA, CARBIDOPA CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA CARBOPLATIN, CARBOPLATIN CERINTA, ETHINYL ESTRADIOL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE DALFAMPRIDINE, DALFAMPRIDINE DEFERASIROX, DEFERASIROX DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOFETILIDE, DOFETILIDE DOXERCALCIFEROL, DOXERCALCIFEROL DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE DROXIDOPA, DROXIDOPA DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENTACAPONE, ENTACAPONE EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC) ESZOPICLONE, ESZOPICLONE FEBUXOSTAT, FEBUXOSTAT FENOFIBRATE, FENOFIBRATE FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE FINASTERIDE, FINASTERIDE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GANIRELIX ACETATE, GANIRELIX ACETATE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC) GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE IBANDRONATE SODIUM, IBANDRONATE SODIUM IMATINIB MESYLATE, IMATINIB MESYLATE INFUGEM, GEMCITABINE HYDROCHLORIDE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE KEMEYA, DROSPIRENONE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE KYRA, DROSPIRENONE LANSOPRAZOLE, LANSOPRAZOLE LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 170 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SUN PHARMACEUTICAL INDUSTRIES LTD LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM LORATADINE, LORATADINE (OTC) LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MESALAMINE, MESALAMINE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHOTREXATE SODIUM, METHOTREXATE SODIUM NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE NIACIN, NIACIN NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OMEPRAZOLE, OMEPRAZOLE (OTC) OPCICON ONE-STEP, LEVONORGESTREL (OTC) PALIPERIDONE, PALIPERIDONE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PREGABALIN, PREGABALIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RANOLAZINE, RANOLAZINE RISEDRONATE SODIUM, RISEDRONATE SODIUM RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE SYLEVIA, ETHINYL ESTRADIOL TADALAFIL, TADALAFIL TEMOZOLOMIDE, TEMOZOLOMIDE TETRABENAZINE, TETRABENAZINE TOBRAMYCIN, TOBRAMYCIN TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VECURONIUM BROMIDE, VECURONIUM BROMIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE SUN PHARM INDS * SUN PHARMACEUTICAL INDUSTRIES LTD CARBIDOPA AND LEVODOPA, CARBIDOPA CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) DESLORATADINE, DESLORATADINE DIVALPROEX SODIUM, DIVALPROEX SODIUM DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLANZAPINE, OLANZAPINE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE SUN PHARM INDS (IN) * SUN PHARMACEUTICAL INDUSTRIES LTD METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ZONISAMIDE, ZONISAMIDE SUN PHARM INDS INC * SUN PHARMACEUTICAL INDUSTRIES INC ABSORICA, ISOTRETINOIN AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 171 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SUN PHARMACEUTICAL INDUSTRIES INC AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT CLONAZEPAM, CLONAZEPAM CLOZAPINE, CLOZAPINE DIGOXIN, DIGOXIN ERGOCALCIFEROL, ERGOCALCIFEROL FLUMADINE, RIMANTADINE HYDROCHLORIDE GLIPIZIDE, GLIPIZIDE GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC) HALOG, HALCINONIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE KENALOG, TRIAMCINOLONE ACETONIDE LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE LITHIUM CARBONATE, LITHIUM CARBONATE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METOPROLOL TARTRATE, METOPROLOL TARTRATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE REPAGLINIDE, REPAGLINIDE TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT TECHNETIUM TC99M MERTIATIDE KIT, TECHNETIUM TC-99M MERTIATIDE KIT TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE SUN PHARM INDS LTD * SUN PHARMACEUTICAL INDUSTRIES LTD ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZITHROMYCIN, AZITHROMYCIN BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DOXYCYCLINE, DOXYCYCLINE FAMOTIDINE, FAMOTIDINE (OTC) FELODIPINE, FELODIPINE FENOFIBRATE, FENOFIBRATE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN GLYCOPYRROLATE, GLYCOPYRROLATE LEVETIRACETAM, LEVETIRACETAM LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LISINOPRIL, LISINOPRIL LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 172 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** * SUN PHARMACEUTICAL INDUSTRIES LTD LORATADINE REDIDOSE, LORATADINE (OTC) LORATADINE, LORATADINE (OTC) MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NAPROXEN SODIUM, NAPROXEN SODIUM (OTC) NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE ONDANSETRON, ONDANSETRON OXCARBAZEPINE, OXCARBAZEPINE PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC) RILUZOLE, RILUZOLE RISPERIDONE, RISPERIDONE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TOPIRAMATE, TOPIRAMATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VALPROIC ACID, VALPROIC ACID SUN PHARM INDUSTRIES * SUN PHARMACEUTICAL INDUSTRIES INC ALBUTEROL SULFATE, ALBUTEROL SULFATE ALLOPURINOL, ALLOPURINOL BACTRIM DS, SULFAMETHOXAZOLE BACTRIM, SULFAMETHOXAZOLE CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE CHLORTHALIDONE, CHLORTHALIDONE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE MESYLATES, ERGOLOID MESYLATES FELODIPINE, FELODIPINE IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE NYSTATIN, NYSTATIN PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE PINDOLOL, PINDOLOL PREDNISONE, PREDNISONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE QUALAQUIN, QUININE SULFATE QUINIDINE GLUCONATE, QUINIDINE GLUCONATE SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE SPIRONOLACTONE, SPIRONOLACTONE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE SULINDAC, SULINDAC TEMAZEPAM, TEMAZEPAM TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE ULTRAVATE, HALOBETASOL PROPIONATE SUN PHARMA GLOBAL * SUN PHARMA GLOBAL FZE BROMSITE, BROMFENAC SODIUM CEQUA, CYCLOSPORINE DECITABINE, DECITABINE DOCETAXEL, DOCETAXEL DRIZALMA SPRINKLE, DULOXETINE HYDROCHLORIDE ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM EZALLOR SPRINKLE, ROSUVASTATIN CALCIUM ODOMZO, PHOSPHATE ORTIKOS, BUDESONIDE XELPROS, LATANOPROST YONSA, ABIRATERONE ACETATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 173 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S ** SUNNY PHARMTECH INC * SUNNY PHARMTECH INC AMINOCAPROIC ACID, AMINOCAPROIC ACID CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN SUNOVION * SUNOVION PHARMACEUTICALS INC BROVANA, ARFORMOTEROL TARTRATE XOPENEX HFA, LEVALBUTEROL TARTRATE SUNOVION PHARMS INC * SUNOVION PHARMACEUTICALS INC APTIOM, ESLICARBAZEPINE ACETATE KYNMOBI, APOMORPHINE HYDROCHLORIDE LATUDA, LURASIDONE HYDROCHLORIDE LUNESTA, ESZOPICLONE SUNOVION RESP * SUNOVION RESPIRATORY DEVELOPMENT INC LONHALA MAGNAIR KIT, GLYCOPYRROLATE SUNSHINE * SUNSHINE LAKE PHARMA CO LTD AZITHROMYCIN, AZITHROMYCIN CLARITHROMYCIN, CLARITHROMYCIN DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ENTACAPONE, ENTACAPONE FEBUXOSTAT, FEBUXOSTAT OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL RANOLAZINE, RANOLAZINE SILDENAFIL CITRATE, SILDENAFIL CITRATE TADALAFIL, TADALAFIL SUNSTAR AMERICAS * SUNSTAR AMERICAS INC PAROEX, CHLORHEXIDINE GLUCONATE SUPERNUS PHARMS * SUPERNUS PHARMACEUTICALS INC OXTELLAR XR, OXCARBAZEPINE QELBREE, VILOXAZINE HYDROCHLORIDE TROKENDI XR, TOPIRAMATE SUVEN PHARMS * SUVEN PHARMACEUTICALS LTD CALCIUM ACETATE, CALCIUM ACETATE MALATHION, MALATHION SVC PHARMA * SVC PHARMA LP DRONABINOL, DRONABINOL SWEDISH ORPHAN * SWEDISH ORPHAN BIOVITRUM AB PUBL ORFADIN, NITISINONE SWISS PHARM * SWISS PHARMACEUTICAL CO LTD GLYBURIDE, GLYBURIDE SYNTHON PHARMS * SYNTHON PHARMACEUTICALS INC LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

** T ** ACME LABS * THE ACME LABORATORIES LTD CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE GEN HOSP * THE GENERAL HOSPITAL CORP AMMONIA N 13, AMMONIA N-13

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 174 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** METHODIST HOSP RES * THE METHODIST HOSP RESEARCH INSTITUTE FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 RITEDOSE CORP * THE RITEDOSE CORP ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE ALBUTEROL SULFATE, ALBUTEROL SULFATE IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE TAGI * TAGI PHARMA INC CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE TAIHO ONCOLOGY * TAIHO ONCOLOGY INC LONSURF, TIPIRACIL HYDROCHLORIDE TAKEDA PHARMS USA * TAKEDA PHARMACEUTICALS USA INC ACTOPLUS MET, METFORMIN HYDROCHLORIDE ACTOS, PIOGLITAZONE HYDROCHLORIDE XR 10, AMPHETAMINE ASPARTATE ADDERALL XR 15, AMPHETAMINE ASPARTATE ADDERALL XR 20, AMPHETAMINE ASPARTATE ADDERALL XR 25, AMPHETAMINE ASPARTATE ADDERALL XR 30, AMPHETAMINE ASPARTATE ADDERALL XR 5, AMPHETAMINE ASPARTATE AGRYLIN, ANAGRELIDE HYDROCHLORIDE ALUNBRIG, CARBATROL, CARBAMAZEPINE COLCRYS, COLCHICINE DEXILANT, DEXLANSOPRAZOLE DUETACT, GLIMEPIRIDE FOSRENOL, LANTHANUM CARBONATE ICLUSIG, HYDROCHLORIDE INTUNIV, GUANFACINE HYDROCHLORIDE KAZANO, ALOGLIPTIN BENZOATE LIALDA, MESALAMINE MOTEGRITY, PRUCALOPRIDE SUCCINATE MYDAYIS, AMPHETAMINE ASPARTATE NESINA, ALOGLIPTIN BENZOATE NINLARO, CITRATE OSENI, ALOGLIPTIN BENZOATE PENTASA, MESALAMINE PREVACID, LANSOPRAZOLE ROZEREM, RAMELTEON TRINTELLIX, HYDROBROMIDE ULORIC, FEBUXOSTAT VELCADE, BORTEZOMIB VYVANSE, LISDEXAMFETAMINE DIMESYLATE TAMARANG * TAMARANG SA ROCURONIUM BROMIDE, ROCURONIUM BROMIDE TARO * TARO PHARMACEUTICAL INDUSTRIES LTD ACETAZOLAMIDE, ACETAZOLAMIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BETAMETHASONE VALERATE, BETAMETHASONE VALERATE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN CARBAMAZEPINE, CARBAMAZEPINE CARVEDILOL, CARVEDILOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 175 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TARO PHARMACEUTICAL INDUSTRIES LTD CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM DESONIDE, DESONIDE ENALAPRIL MALEATE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM FELBAMATE, FELBAMATE FLUCONAZOLE, FLUCONAZOLE FLUOROURACIL, FLUOROURACIL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE GABAPENTIN, GABAPENTIN GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE IMIQUIMOD, IMIQUIMOD IVERMECTIN, IVERMECTIN (OTC) KETOCONAZOLE, KETOCONAZOLE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LORATADINE, LORATADINE (OTC) MELOXICAM, MELOXICAM METRONIDAZOLE, METRONIDAZOLE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC) NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NYSTATIN, NYSTATIN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXCARBAZEPINE, OXCARBAZEPINE PHENYTOIN, PHENYTOIN TERIL, CARBAMAZEPINE WARFARIN SODIUM, WARFARIN SODIUM * TARO PHARMACEUTICALS USA INC ACETIC ACID, ACETIC ACID, GLACIAL ACYCLOVIR, ACYCLOVIR ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE ADAPALENE, ADAPALENE ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE AMMONIUM LACTATE, AMMONIUM LACTATE AZELAIC ACID, AZELAIC ACID BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE, CLOTRIMAZOLE CLOTRIMAZOLE, CLOTRIMAZOLE (OTC) DAPSONE, DAPSONE DERMABET, BETAMETHASONE VALERATE DESONIDE, DESONIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE FLUOCINONIDE, FLUOCINONIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 176 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TARO PHARMACEUTICALS USA INC HYDROCORTISONE, HYDROCORTISONE IBUPROFEN, IBUPROFEN IBUPROFEN, IBUPROFEN (OTC) KETOZOLE, KETOCONAZOLE LIDOCAINE, LIDOCAINE LORATADINE, LORATADINE (OTC) MICONAZOLE 3, MICONAZOLE NITRATE (OTC) MOMETASONE FUROATE, MOMETASONE FUROATE MUPIROCIN, MUPIROCIN MUPIROCIN, MUPIROCIN CALCIUM NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN PHENYTOIN, PHENYTOIN PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC) TERCONAZOLE, TERCONAZOLE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC) U-CORT, HYDROCORTISONE ACETATE TARO PHARM INDS * TARO PHARMACEUTICAL INDUSTRIES LTD AMCINONIDE, AMCINONIDE CARBAMAZEPINE, CARBAMAZEPINE CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE ETODOLAC, ETODOLAC HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE LAMOTRIGINE, LAMOTRIGINE TARO PHARM INDS LTD * TARO PHARMACEUTICAL INDUSTRIES LTD ACETAMINOPHEN, ACETAMINOPHEN (OTC) BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN DEFERIPRONE, DEFERIPRONE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL HYDROCORTISONE, HYDROCORTISONE INFANTS' FEVERALL, ACETAMINOPHEN (OTC) LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE TOPICORT, DESOXIMETASONE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TARO PHARMS * TARO PHARMACEUTICALS INC BUTENAFINE HYDROCHLORIDE, BUTENAFINE HYDROCHLORIDE (OTC) CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DAPSONE, DAPSONE MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC) NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE OXICONAZOLE NITRATE, OXICONAZOLE NITRATE PLIAGLIS, LIDOCAINE TAVABOROLE, TAVABOROLE TAZAROTENE, TAZAROTENE TOPICORT, DESOXIMETASONE TRETINOIN, TRETINOIN TASMAN PHARMA * TASMAN PHARMA INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 177 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TASMAN PHARMA INC CLOTRIMAZOLE, CLOTRIMAZOLE DROXIDOPA, DROXIDOPA FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE VERSACLOZ, CLOZAPINE TCG FLUENT PHARMA * TCG FLUENT PHARMA INVESTORS LP FLOLIPID, SIMVASTATIN TEIKOKU PHARMA USA * TEIKOKU PHARMA USA INC LIDODERM, LIDOCAINE TELIGENT * TELIGENT OU CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE FORTAZ, CEFTAZIDIME ZANTAC, RANITIDINE HYDROCHLORIDE * TELIGENT PHARMA INC BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CEFOTAN, CEFOTETAN DISODIUM CICLOPIROX, CICLOPIROX CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DESONIDE, DESONIDE DESOXIMETASONE, DESOXIMETASONE DICLOFENAC SODIUM, DICLOFENAC SODIUM DIFLORASONE DIACETATE, DIFLORASONE DIACETATE ECONAZOLE NITRATE, ECONAZOLE NITRATE ERYTHROMYCIN, ERYTHROMYCIN FLUOCINONIDE, FLUOCINONIDE FLURANDRENOLIDE, FLURANDRENOLIDE GENTAMICIN SULFATE, GENTAMICIN SULFATE HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE LIDOCAINE AND PRILOCAINE, LIDOCAINE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE LIDOCAINE, LIDOCAINE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE ZINACEF, CEFUROXIME SODIUM TENSHI * TENSHI KAIZEN PVT LTD LORATADINE, LORATADINE (OTC) TERSERA * TERSERA THERAPEUTICS LLC ERGOMAR, ERGOTAMINE TARTRATE PRIALT, ACETATE VARUBI, HYDROCHLORIDE XERMELO, TELOTRISTAT ETIPRATE ZOLADEX, ACETATE TETRAPHASE PHARMS * TETRAPHASE PHARMACEUTICALS INC XERAVA, DIHYDROCHLORIDE TEVA * TEVA NEUROSCIENCE INC AZILECT, RASAGILINE MESYLATE * TEVA PHARMACEUTICALS USA INC ACYCLOVIR, ACYCLOVIR ADIPEX-P, PHENTERMINE HYDROCHLORIDE ALBUTEROL SULFATE, ALBUTEROL SULFATE AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN PEDIATRIC, AMOXICILLIN AMOXICILLIN, AMOXICILLIN ATENOLOL, ATENOLOL AZITHROMYCIN, AZITHROMYCIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 178 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TEVA PHARMACEUTICALS USA INC BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CALCITRIOL, CALCITRIOL CARVEDILOL, CARVEDILOL CEFACLOR, CEFACLOR CEFPROZIL, CEFPROZIL CELECOXIB, CELECOXIB CEPHALEXIN, CEPHALEXIN CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) CILOSTAZOL, CILOSTAZOL CIMETIDINE, CIMETIDINE CLARITHROMYCIN, CLARITHROMYCIN CLEMASTINE FUMARATE, CLEMASTINE FUMARATE CLONAZEPAM, CLONAZEPAM CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CLOTRIMAZOLE, CLOTRIMAZOLE DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM SODIUM, DICLOXACILLIN SODIUM DIFLUNISAL, DIFLUNISAL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE EPITOL, CARBAMAZEPINE ESZOPICLONE, ESZOPICLONE ETODOLAC, ETODOLAC FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE FINASTERIDE, FINASTERIDE FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE FLUOCINONIDE, FLUOCINONIDE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLURBIPROFEN, FLURBIPROFEN FOSINOPRIL SODIUM, FOSINOPRIL SODIUM GALZIN, GLYBURIDE (MICRONIZED), GLYBURIDE GLYBURIDE, GLYBURIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE KETOCONAZOLE, KETOCONAZOLE KETOPROFEN, KETOPROFEN KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEVOFLOXACIN, LEVOFLOXACIN LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE LOVASTATIN, LOVASTATIN METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE MUPIROCIN, MUPIROCIN NAPROXEN, NAPROXEN HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE NEOMYCIN SULFATE, NEOMYCIN SULFATE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE NYSTATIN, NYSTATIN OFLOXACIN, OFLOXACIN ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXAPROZIN, OXAPROZIN OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PENICILLIN-VK, PENICILLIN V POTASSIUM PIROXICAM, PIROXICAM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 179 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TEVA PHARMACEUTICALS USA INC PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRELONE, PREDNISOLONE SILDENAFIL CITRATE, SILDENAFIL CITRATE SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE SUCRALFATE, SUCRALFATE TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE TOLMETIN SODIUM, TOLMETIN SODIUM TOPIRAMATE, TOPIRAMATE TORSEMIDE, TORSEMIDE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE TEVA BRANDED PHARM * TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC AUSTEDO, DEUTETRABENAZINE CONDYLOX, PODOFILOX EMLA, LIDOCAINE LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL LOESTRIN 21 1/20, ETHINYL ESTRADIOL LOESTRIN 24 FE, ETHINYL ESTRADIOL LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL LOESTRIN FE 1/20, ETHINYL ESTRADIOL LOSEASONIQUE, ETHINYL ESTRADIOL MICROZIDE, HYDROCHLOROTHIAZIDE NOR-QD, NORETHINDRONE PROAIR DIGIHALER, ALBUTEROL SULFATE PROAIR HFA, ALBUTEROL SULFATE PROAIR RESPICLICK, ALBUTEROL SULFATE PROGLYCEM, DIAZOXIDE QNASL, BECLOMETHASONE DIPROPIONATE QUARTETTE, ETHINYL ESTRADIOL SEASONALE, ETHINYL ESTRADIOL SEASONIQUE, ETHINYL ESTRADIOL ZIAC, BISOPROLOL FUMARATE TEVA PARENTERAL * TEVA PARENTERAL MEDICINES INC LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE TEVA PHARM * TEVA PHARMACEUTICAL INDUSTRIES LTD AIRDUO DIGIHALER, FLUTICASONE PROPIONATE AIRDUO RESPICLICK, FLUTICASONE PROPIONATE ARMONAIR DIGIHALER, FLUTICASONE PROPIONATE TEVA PHARMS * TEVA PHARMACEUTICALS USA AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE BUDESONIDE, BUDESONIDE CARBAMAZEPINE, CARBAMAZEPINE CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE CEFDINIR, CEFDINIR CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE CROMOLYN SODIUM, CROMOLYN SODIUM DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE FAMCICLOVIR, FAMCICLOVIR FLUVASTATIN SODIUM, FLUVASTATIN SODIUM GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IRBESARTAN, IRBESARTAN LANSOPRAZOLE, LANSOPRAZOLE LETROZOLE, LETROZOLE LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE LINEZOLID, LINEZOLID LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 180 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TEVA PHARMACEUTICALS USA MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN PACLITAXEL, PACLITAXEL PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE PREGABALIN, PREGABALIN QUETIAPINE FUMARATE, QUETIAPINE FUMARATE QUININE SULFATE, QUININE SULFATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SILDENAFIL CITRATE, SILDENAFIL CITRATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TRANDOLAPRIL, TRANDOLAPRIL URSODIOL, URSODIOL VANDAZOLE, METRONIDAZOLE VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE TEVA PHARMS INTL * TEVA PHARMACEUTICALS INTERNATIONAL GMBH AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE SYNRIBO, OMACETAXINE MEPESUCCINATE TEVA PHARMS USA * TEVA PHARMACEUTICALS USA ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE ACITRETIN, ACITRETIN ADENOSINE, ADENOSINE ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE ATAZANAVIR SULFATE, ATAZANAVIR SULFATE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM BEXAROTENE, BEXAROTENE BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUDESONIDE, BUDESONIDE CLARAVIS, ISOTRETINOIN CLOZAPINE, CLOZAPINE COPAXONE, GLATIRAMER ACETATE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM EPTIFIBATIDE, EPTIFIBATIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESTRADIOL, ESTRADIOL ETOPOSIDE, ETOPOSIDE FLUOROURACIL, FLUOROURACIL FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVASTATIN SODIUM, FLUVASTATIN SODIUM FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE IMATINIB MESYLATE, IMATINIB MESYLATE IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE LANSOPRAZOLE, LANSOPRAZOLE LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEUPROLIDE ACETATE, LEUPROLIDE ACETATE LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 181 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TEVA PHARMACEUTICALS USA LOGILIA, ULIPRISTAL ACETATE METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS OMEPRAZOLE, OMEPRAZOLE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PARICALCITOL, PARICALCITOL PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE RISEDRONATE SODIUM, RISEDRONATE SODIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE TADALAFIL, TADALAFIL TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TOBRAMYCIN, TOBRAMYCIN TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TREPROSTINIL, TREPROSTINIL VECURONIUM BROMIDE, VECURONIUM BROMIDE VIGABATRIN, VIGABATRIN VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE ZANOSAR, STREPTOZOCIN * TEVA PHARMACEUTICALS USA INC ABIRATERONE ACETATE, ABIRATERONE ACETATE ALYQ, TADALAFIL AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN CAPECITABINE, CAPECITABINE DAPTOMYCIN, DAPTOMYCIN DARUNAVIR, DARUNAVIR DEFERASIROX, DEFERASIROX EFINACONAZOLE, EFINACONAZOLE ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE EPINEPHRINE (AUTOINJECTOR), EPINEPHRINE ESTRADIOL, ESTRADIOL EVEROLIMUS, EVEROLIMUS ICATIBANT ACETATE, ICATIBANT ACETATE IVERMECTIN, IVERMECTIN LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE MESALAMINE, MESALAMINE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE METRONIDAZOLE, METRONIDAZOLE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM TOBRAMYCIN, TOBRAMYCIN TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE TEVA PHARMS USA INC * TEVA PHARMACEUTICALS USA INC CHLORZOXAZONE, CHLORZOXAZONE DROXIDOPA, DROXIDOPA

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 182 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TEVA PHARMACEUTICALS USA INC ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE ERYTHROMYCIN, ERYTHROMYCIN ETHINYL ESTRADIOL; ETONOGESTREL, ETHINYL ESTRADIOL FORMOTEROL FUMARATE, FORMOTEROL FUMARATE FULVESTRANT, FULVESTRANT LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM MIFEPRISTONE, MIFEPRISTONE POTASSIUM CITRATE, POTASSIUM CITRATE ROMIDEPSIN, ROMIDEPSIN TIOPRONIN, TIOPRONIN TG THERAPS * TG THERAPEUTICS INC UKONIQ, TOSYLATE THE FEINSTEIN INST * THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 THEPHARMANETWORK LLC * THEPHARMANETWORK LLC BENZONATATE, BENZONATATE ISONIAZID, ISONIAZID METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE NIMODIPINE, NIMODIPINE THERMAZENE, SILVER SULFADIAZINE THERAPEUTICSMD INC * THERAPEUTICSMD INC ANNOVERA, ETHINYL ESTRADIOL BIJUVA, ESTRADIOL IMVEXXY, ESTRADIOL TIANJIN KINGYORK * TIANJIN KINGYORK PHARMACEUTICALS CO LTD METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE TIANJIN TIANYAO * TIANJIN TIANYAO PHARMACEUTICALS CO LTD CELECOXIB, CELECOXIB METHYLPREDNISOLONE, METHYLPREDNISOLONE TIME-CAP LABS INC * TIME-CAP LABORATORIES INC VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE TOLMAR * TOLMAR INC ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE ADAPALENE, ADAPALENE AZELAIC ACID, AZELAIC ACID CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE CALCIPOTRIENE, CALCIPOTRIENE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DICLOFENAC SODIUM, DICLOFENAC SODIUM ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE KETOCONAZOLE, KETOCONAZOLE LIDOCAINE AND PRILOCAINE, LIDOCAINE METRONIDAZOLE, METRONIDAZOLE NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE * TOLMAR INTERNATIONAL LTD FENSOLVI KIT, LEUPROLIDE ACETATE TOLMAR THERAP * TOLMAR THERAPEUTICS INC ELIGARD KIT, LEUPROLIDE ACETATE TOPROL * TOPROL ACQUISITION LLC TOPROL-XL, METOPROLOL SUCCINATE TORPHARM * TORPHARM INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 183 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TORPHARM INC CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE TORRENT * TORRENT PHARMA INC APREPITANT, APREPITANT ERYTHROMYCIN, ERYTHROMYCIN LACTULOSE, LACTULOSE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE * LTD ACYCLOVIR, ACYCLOVIR AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE ARIPIPRAZOLE, ARIPIPRAZOLE CELECOXIB, CELECOXIB CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM FENOFIBRATE (MICRONIZED), FENOFIBRATE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE LAMOTRIGINE, LAMOTRIGINE MONTELUKAST SODIUM, MONTELUKAST SODIUM MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN NYSTATIN, NYSTATIN OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM ROFLUMILAST, ROFLUMILAST ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE TADALAFIL, TADALAFIL TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TORRENT PHARMS * TORRENT PHARMACEUTICALS LTD CARBAMAZEPINE, CARBAMAZEPINE CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE RISPERIDONE, RISPERIDONE ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE TORRENT PHARMS LLC * TORRENT PHARMACEUTICALS LLC OLANZAPINE, OLANZAPINE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE TORRENT PHARMS LTD * TORRENT PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE FELODIPINE, FELODIPINE MONTELUKAST SODIUM, MONTELUKAST SODIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE TRAVERE * TRAVERE THERAPEUTICS INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 184 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T ** * TRAVERE THERAPEUTICS INC CHOLBAM, TREVENA * TREVENA INC OLINVYK, OLICERIDINE TRIPOINT * TRIPOINT THERAPEUTICS ELEPSIA XR, LEVETIRACETAM TRIS PHARMA INC * TRIS PHARMA INC CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC) DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC) DROXIDOPA, DROXIDOPA DYANAVEL XR, AMPHETAMINE GABAPENTIN, GABAPENTIN HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX IBUPROFEN, IBUPROFEN (OTC) LEVETIRACETAM, LEVETIRACETAM METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MORPHINE SULFATE, MORPHINE SULFATE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE THEOPHYLLINE, THEOPHYLLINE TRUSTEES UNIV PA * TRUSTEES OF THE UNIV OF PENNSYLVANIA FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 TULEX PHARMS INC * TULEX PHARMACEUTICALS INC AMINOCAPROIC ACID, AMINOCAPROIC ACID CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE TWI PHARMS * TWI PHARMACEUTICALS INC BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE MEGESTROL ACETATE, MEGESTROL ACETATE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE NIFEDIPINE, NIFEDIPINE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE SEVELAMER CARBONATE, SEVELAMER CARBONATE TERBUTALINE SULFATE, TERBUTALINE SULFATE TESTOSTERONE, TESTOSTERONE TWI PHARMS INC * TWI PHARMACEUTICALS INC CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

** U ** UBI * UBI PHARMA INC DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE UCB INC * UCB INC BRIVIACT, BRIVARACETAM

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 185 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U ** * UCB INC KEPPRA XR, LEVETIRACETAM KEPPRA, LEVETIRACETAM NAYZILAM, MIDAZOLAM NEUPRO, VIMPAT, UCLA BIOMEDICAL * UCLA BIOMEDICAL CYCLOTRON AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UCSF RODIOPHARM * UCSF RADIOPHARMACEUTICAL FACILITY AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UIHC PET IMAGING * UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 GALLIUM DOTATOC GA 68, GALLIUM DOTATOC GA-68 PHARM INC * ULTRAGENYX PHARMACEUTICAL INC DOJOLVI, UMEDICA LABS PVT LTD * UMEDICA LABORATORIES PRIVATE LTD ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM CARBAMAZEPINE, CARBAMAZEPINE CELECOXIB, CELECOXIB CHLORTHALIDONE, CHLORTHALIDONE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL SILDENAFIL CITRATE, SILDENAFIL CITRATE TADALAFIL, TADALAFIL UNICHEM * UNICHEM LABORATORIES LTD ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE ALLOPURINOL, ALLOPURINOL AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE APREMILAST, APREMILAST ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATENOLOL, ATENOLOL BACLOFEN, BACLOFEN BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE BISOPROLOL FUMARATE, BISOPROLOL FUMARATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CELECOXIB, CELECOXIB CHLORTHALIDONE, CHLORTHALIDONE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE MELOXICAM, MELOXICAM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METRONIDAZOLE, METRONIDAZOLE MONTELUKAST SODIUM, MONTELUKAST SODIUM PIROXICAM, PIROXICAM QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE TADALAFIL, TADALAFIL TOLTERODINE TARTRATE, TOLTERODINE TARTRATE TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE ZALEPLON, ZALEPLON ZONISAMIDE, ZONISAMIDE UNICHEM LABS LTD

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 186 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U ** * UNICHEM LABORATORIES LIMITED DIVALPROEX SODIUM, DIVALPROEX SODIUM * UNICHEM LABORATORIES LTD LAMOTRIGINE, LAMOTRIGINE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE UNIMARK REMEDIES LTD * UNIMARK REMEDIES LTD MONTELUKAST SODIUM, MONTELUKAST SODIUM UNIQUE PHARM * UNIQUE PHARMACEUTICAL LABORATORIES CARBAMAZEPINE, CARBAMAZEPINE LORATADINE, LORATADINE (OTC) UNIQUE PHARM LABS * UNIQUE PHARMACEUTICAL LABORATORIES A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD ATENOLOL, ATENOLOL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC) CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FLUCONAZOLE, FLUCONAZOLE GLIPIZIDE, GLIPIZIDE LITHIUM CARBONATE, LITHIUM CARBONATE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC) TINIDAZOLE, TINIDAZOLE TOLTERODINE TARTRATE, TOLTERODINE TARTRATE UNITED BIOMEDCL * UNITED BIOMEDICAL INC TERBUTALINE SULFATE, TERBUTALINE SULFATE UNITED GUARDIAN * UNITED GUARDIAN INC RENACIDIN, CITRIC ACID UNITED THERAP * UNITED THERAPEUTICS CORP ORENITRAM, TREPROSTINIL DIOLAMINE REMODULIN, TREPROSTINIL TYVASO, TREPROSTINIL UNIV CA LOS ANGELES * UNIV CALIFORNIA LOS ANGELES GALLIUM GA 68 PSMA-11, GALLIUM GA-68 PSMA-11 UNIV MICHIGAN * UNIV MICHIGAN PET RADIOPHARMACEUTICAL PRODUCTION PROGRAM FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UNIV OF CA SAN FRAN * UNIV OF CALIFORNIA SAN FRANCISCO GALLIUM GA 68 PSMA-11, GALLIUM GA-68 PSMA-11 UNIV SOUTHERN CA * UNIV SOUTHERN CALIFORNIA DBA USC MOLECULAR IMAGING CENTER FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UNIV TX MD ANDERSON * UNIV TEXAS MD ANDERSON CANCER CENTER CHOLINE C-11, CHOLINE C-11 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 UNIV TX SW MEDCTR * UNIV TEXAS SOUTHWESTERN MEDCTR AMMONIA N 13, AMMONIA N-13 UNIV UTAH CYCLOTRON * UNIV UTAH CYCLOTRON RADIOCHEMISTRY LAB FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 187 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U ** UNIV WISCONSIN * UNIV WISCONSIN SYSTEM AMMONIA N 13, AMMONIA N-13 UPJOHN * UPJOHN MANUFACTURING IRELAND UNLTD LIPITOR, ATORVASTATIN CALCIUM RELPAX, ELETRIPTAN HYDROBROMIDE * UPJOHN US 1 LLC CARDURA XL, DOXAZOSIN MESYLATE CARDURA, DOXAZOSIN MESYLATE DILANTIN, PHENYTOIN SODIUM DILANTIN-125, PHENYTOIN GEODON, ZIPRASIDONE HYDROCHLORIDE GEODON, ZIPRASIDONE MESYLATE NEURONTIN, GABAPENTIN NITROSTAT, NITROGLYCERIN NORVASC, AMLODIPINE BESYLATE REVATIO, SILDENAFIL CITRATE VIAGRA, SILDENAFIL CITRATE ZOLOFT, SERTRALINE HYDROCHLORIDE * UPJOHN US 2 LLC CELEBREX, CELECOXIB DETROL LA, TOLTERODINE TARTRATE DETROL, TOLTERODINE TARTRATE EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE INSPRA, EPLERENONE LYRICA CR, PREGABALIN LYRICA, PREGABALIN XALATAN, LATANOPROST XANAX XR, ALPRAZOLAM XANAX, ALPRAZOLAM UPSHER SMITH LABS * UPSHER SMITH LABORATORIES LLC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BACLOFEN, BACLOFEN BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE BEXAROTENE, BEXAROTENE BUMETANIDE, BUMETANIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CLOBAZAM, CLOBAZAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE DIVALPROEX SODIUM, DIVALPROEX SODIUM DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ETHACRYNIC ACID, ETHACRYNIC ACID EXEMESTANE, EXEMESTANE FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE FOSINOPRIL SODIUM, FOSINOPRIL SODIUM HALOPERIDOL, HALOPERIDOL HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE ISOTRETINOIN, ISOTRETINOIN JANTOVEN, WARFARIN SODIUM KLOR-CON M10, POTASSIUM CHLORIDE KLOR-CON M15, POTASSIUM CHLORIDE KLOR-CON M20, POTASSIUM CHLORIDE KLOR-CON, POTASSIUM CHLORIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MORPHINE SULFATE, MORPHINE SULFATE MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 188 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U ** * UPSHER SMITH LABORATORIES LLC NYSTATIN, NYSTATIN ORVATEN, MIDODRINE HYDROCHLORIDE OXANDROLONE, OXANDROLONE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PACERONE, AMIODARONE HYDROCHLORIDE PREVALITE, CHOLESTYRAMINE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE QUDEXY XR, TOPIRAMATE SORINE, SOTALOL HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TOSYMRA, SUMATRIPTAN URSODIOL, URSODIOL VOGELXO, TESTOSTERONE ZEMBRACE SYMTOUCH, SUMATRIPTAN SUCCINATE UROGEN PHARMA * UROGEN PHARMA LTD JELMYTO, MITOMYCIN UROVANT * UROVANT SCIENCES GMBH GEMTESA, US * US ANTIBIOTICS LLC AMOXIL, AMOXICILLIN AUGMENTIN '125', AMOXICILLIN AUGMENTIN '250', AMOXICILLIN AUGMENTIN '875', AMOXICILLIN AUGMENTIN ES-600, AMOXICILLIN LAROTID, AMOXICILLIN USPHARMA * USPHARMA LTD DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE NITRO-DUR, NITROGLYCERIN USV * USV PRIVATE LTD OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC) ZOLEDRONIC ACID, ZOLEDRONIC ACID USWM * USWM LLC CORGARD, NADOLOL LUCEMYRA, HYDROCHLORIDE REVONTO, DANTROLENE SODIUM

** V ** VALEANT * VALEANT PHARMACEUTICALS INTERNATIONAL BONTRIL PDM, PHENDIMETRAZINE TARTRATE MYSOLINE, PRIMIDONE VALEANT BERMUDA * VALEANT INTERNATIONAL BERMUDA PENLAC, CICLOPIROX RETIN-A, TRETINOIN VALEANT INTL * VALEANT INTERNATIONAL BARBADOS SRL RETIN-A MICRO, TRETINOIN RETIN-A, TRETINOIN RETIN-A-MICRO, TRETINOIN * VALEANT INTERNATIONAL SRL BENZAMYCIN, BENZOYL PEROXIDE VALEANT LUXEMBOURG * VALEANT PHARMACEUTICALS LUXEMBOURG SARL TARGRETIN, BEXAROTENE VISUDYNE,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 189 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V ** VALEANT PHARM INTL * VALEANT PHARMACEUTICALS INTERNATIONAL ANDROID 25, METHYLTESTOSTERONE LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE VALEANT PHARMS * VALEANT PHARMACEUTICALS NORTH AMERICA LLC PENTOXIFYLLINE, PENTOXIFYLLINE VALEANT PHARMS INTL * VALEANT PHARMACEUTICALS INTERNATIONAL APRISO, MESALAMINE COLAZAL, BALSALAZIDE DISODIUM CUPRIMINE, PENICILLAMINE LACRISERT, HYDROXYPROPYL TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE TIMOPTIC, TIMOLOL MALEATE VALEANT PHARMS LLC * VALEANT PHARMACEUTICALS NORTH AMERICA LLC TIMOPTIC-XE, TIMOLOL MALEATE VALEANT PHARMS NORTH * VALEANT PHARMACEUTICALS NORTH AMERICA LLC CARAC, FLUOROURACIL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE FENOFIBRATE, FENOFIBRATE NIFEDIPINE, NIFEDIPINE NORITATE, METRONIDAZOLE RENOVA, TRETINOIN RETIN-A, TRETINOIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE VALIDUS PHARMS * VALIDUS PHARMACEUTICALS LLC BUMEX, BUMETANIDE DRISDOL, ERGOCALCIFEROL EQUETRO, CARBAMAZEPINE LASIX, FUROSEMIDE LOPRESSOR HCT, HYDROCHLOROTHIAZIDE LOPRESSOR, METOPROLOL TARTRATE LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE LOTENSIN, BENAZEPRIL HYDROCHLORIDE NORPRAMIN, DESIPRAMINE HYDROCHLORIDE PARLODEL, BROMOCRIPTINE MESYLATE ROCALTROL, CALCITRIOL VALIDUS PHARMS INC * VALIDUS PHARMACEUTICALS INC MARPLAN, VANDA PHARMS INC * VANDA PHARMACEUTICALS INC FANAPT, HETLIOZ LQ, HETLIOZ, TASIMELTEON VELOXIS PHARMS INC * VELOXIS PHARMACEUTICALS INC ENVARSUS XR, TACROLIMUS VERITY * VERITY PHARMACEUTICALS INC TRELSTAR, TRIPTORELIN PAMOATE VERO BIOTECH * VERO BIOTECH GENOSYL, NITRIC OXIDE VEROSCIENCE * VEROSCIENCE LLC CYCLOSET, BROMOCRIPTINE MESYLATE VERTEX PHARMS * INC KALYDECO,

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 190 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V ** VERTEX PHARMS INC * VERTEX PHARMACEUTICALS INC KALYDECO, IVACAFTOR ORKAMBI, IVACAFTOR SYMDEKO (COPACKAGED), IVACAFTOR TRIKAFTA (COPACKAGED), ELEXACAFTOR, IVACAFTOR, TEZACAFTOR VERTICAL PHARMS LLC * VERTICAL PHARMACEUTICALS LLC DIVIGEL, ESTRADIOL VGYAAN * VGYAAN PHARMACEUTICALS LLC CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE NADOLOL, NADOLOL VICURON * VICURON PHARMACEUTICALS INC ERAXIS, VIFOR FRESENIUS * VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA VELPHORO, FERRIC OXYHYDROXIDE VIFOR PHARMA * VIFOR PHARMA INC VELTASSA, PATIROMER SORBITEX CALCIUM VIIV HLTHCARE * VIIV HEALTHCARE CO CABENUVA KIT, CABOTEGRAVIR COMBIVIR, LAMIVUDINE DOVATO, DOLUTEGRAVIR SODIUM EPIVIR, LAMIVUDINE EPZICOM, ABACAVIR SULFATE JULUCA, DOLUTEGRAVIR SODIUM LEXIVA, FOSAMPRENAVIR CALCIUM RETROVIR, ZIDOVUDINE RUKOBIA, FOSTEMSAVIR TROMETHAMINE SELZENTRY, MARAVIROC TIVICAY PD, DOLUTEGRAVIR SODIUM TIVICAY, DOLUTEGRAVIR SODIUM TRIUMEQ, ABACAVIR SULFATE TRIZIVIR, ABACAVIR SULFATE VOCABRIA, CABOTEGRAVIR SODIUM ZIAGEN, ABACAVIR SULFATE VINTAGE * VINTAGE PHARMACEUTICALS LLC BENZTROPINE MESYLATE, BENZTROPINE MESYLATE DUTASTERIDE, DUTASTERIDE VINTAGE PHARMS * VINTAGE PHARMACEUTICALS ALPRAZOLAM, ALPRAZOLAM DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE GILDAGIA, ETHINYL ESTRADIOL GILDESS 24 FE, ETHINYL ESTRADIOL KIMIDESS, DESOGESTREL PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE * VINTAGE PHARMACEUTICALS INC ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE BACLOFEN, BACLOFEN BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN DIAZEPAM, DIAZEPAM HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN IBUPROFEN, IBUPROFEN (OTC) METHYLPREDNISOLONE, METHYLPREDNISOLONE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN PERPHENAZINE, PERPHENAZINE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 191 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V ** * VINTAGE PHARMACEUTICALS INC PREDNISONE, PREDNISONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE TORSEMIDE, TORSEMIDE VINTAGE PHARMS LLC * VINTAGE PHARMACEUTICALS LLC CYCLAFEM 1/35, ETHINYL ESTRADIOL CYCLAFEM 7/7/7, ETHINYL ESTRADIOL FELODIPINE, FELODIPINE GILDESS 1/20, ETHINYL ESTRADIOL GILDESS FE 1/20, ETHINYL ESTRADIOL MORPHINE SULFATE, MORPHINE SULFATE MYZILRA, ETHINYL ESTRADIOL PERCOCET, ACETAMINOPHEN PREVIFEM, ETHINYL ESTRADIOL VIRTUS PHARM * VIRTUS PHARMACEUTICAL INC ACARBOSE, ACARBOSE ALBUTEROL SULFATE, ALBUTEROL SULFATE PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE VIRTUS PHARMS * VIRTUS PHARMACEUTICALS LLC DAPSONE, DAPSONE LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PROMETRIUM, PROGESTERONE VISTA PHARMS * VISTA PHARMACEUTICALS INC SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE VISTAPHARM * VISTAPHARM INC ACYCLOVIR, ACYCLOVIR AMINOCAPROIC ACID, AMINOCAPROIC ACID ARIPIPRAZOLE, ARIPIPRAZOLE CHLORTHALIDONE, CHLORTHALIDONE CLOBAZAM, CLOBAZAM DIGOXIN, DIGOXIN FELBAMATE, FELBAMATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN LACTULOSE, LACTULOSE METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL NYSTATIN, NYSTATIN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENYTOIN, PHENYTOIN THYQUIDITY, LEVOTHYROXINE SODIUM VITRUVIAS THERAP * VITRUVIAS THERAPEUTICS POTASSIUM CHLORIDE, POTASSIUM CHLORIDE * VITRUVIAS THERAPEUTICS LLC CYANOCOBALAMIN, CYANOCOBALAMIN LIDOCAINE, LIDOCAINE VIVUS * VIVUS INC QSYMIA, PHENTERMINE HYDROCHLORIDE VIWIT PHARM * VIWIT PHARMACEUTICAL CO LTD LEVETIRACETAM, LEVETIRACETAM SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE VKT PHARMA * VKT PHARMA PRIVATE LTD LEVETIRACETAM, LEVETIRACETAM RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 192 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V ** VPI PHARMS INC * VPI PHARMACEUTICALS INC ETHACRYNATE SODIUM, ETHACRYNATE SODIUM VPNA * VALEANT PHARMACEUTICALS NORTH AMERICA DICLOFENAC SODIUM, DICLOFENAC SODIUM VYERA PHARMS LLC * VYERA PHARMACEUTICALS LLC DARAPRIM, PYRIMETHAMINE VYNE * VYNE PHARMACEUTICALS INC AMZEEQ, MINOCYCLINE HYDROCHLORIDE ZILXI, MINOCYCLINE HYDROCHLORIDE

** W ** WA UNIV SCH MED * WASHINGTON UNIV SCHOOL MEDICINE AMMONIA N 13, AMMONIA N-13 CHOLINE C-11, CHOLINE C-11 WATSON LABS * WATSON LABORATORIES FOLIC ACID, FOLIC ACID PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE * WATSON LABORATORIES INC ACARBOSE, ACARBOSE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALENDRONATE SODIUM, ALENDRONATE SODIUM ALLOPURINOL, ALLOPURINOL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE , AMOXAPINE ATENOLOL AND CHLORTHALIDONE, ATENOLOL CARISOPRODOL, CARISOPRODOL CHLORZOXAZONE, CHLORZOXAZONE CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE COL-PROBENECID, COLCHICINE DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE ESTAZOLAM, ESTAZOLAM GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE, GLIPIZIDE GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LISINOPRIL, LISINOPRIL LORAZEPAM, LORAZEPAM LOSARTAN POTASSIUM, LOSARTAN POTASSIUM LOXAPINE SUCCINATE, LOXAPINE SUCCINATE METHYLPREDNISOLONE, METHYLPREDNISOLONE METRONIDAZOLE, METRONIDAZOLE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MINOXIDIL, MINOXIDIL NABUMETONE, NABUMETONE NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE NATEGLINIDE, NATEGLINIDE NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NIZATIDINE, NIZATIDINE NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL ORPHENADRINE CITRATE, ORPHENADRINE CITRATE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PREDNISOLONE, PREDNISOLONE PREDNISONE, PREDNISONE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 193 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WATSON LABORATORIES INC PRIMIDONE, PRIMIDONE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE QUASENSE, ETHINYL ESTRADIOL RAMIPRIL, RAMIPRIL RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE SULFASALAZINE, SULFASALAZINE SULINDAC, SULINDAC SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE TRIMETHOPRIM, TRIMETHOPRIM VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE ZOVIA 1/50E-28, ETHINYL ESTRADIOL * WATSON LABS INC LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE WATSON LABS INC * WATSON LABORATORIES INC AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMBRISENTAN, AMBRISENTAN AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE BOSENTAN, BOSENTAN BRINZOLAMIDE, BRINZOLAMIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CELECOXIB, CELECOXIB CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE COLCHICINE, COLCHICINE DICLOFENAC SODIUM, DICLOFENAC SODIUM DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE EZETIMIBE AND SIMVASTATIN, EZETIMIBE EZETIMIBE, EZETIMIBE METRONIDAZOLE, METRONIDAZOLE MODAFINIL, MODAFINIL MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN PENICILLAMINE, PENICILLAMINE PERPHENAZINE, PERPHENAZINE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE PROPOFOL, PROPOFOL RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SILDENAFIL CITRATE, SILDENAFIL CITRATE SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE WATSON LABS TEVA * WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC ALVIMOPAN, ALVIMOPAN BICALUTAMIDE, BICALUTAMIDE BUPRENORPHINE, BUPRENORPHINE CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE GLIPIZIDE, GLIPIZIDE IBANDRONATE SODIUM, IBANDRONATE SODIUM ISRADIPINE, ISRADIPINE LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL PROBENECID, PROBENECID SIMVASTATIN, SIMVASTATIN TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE WATSON PHARMS INC * WATSON PHARMACEUTICALS INC

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 194 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WATSON PHARMACEUTICALS INC TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE WAYLIS THERAP * WAYLIS THERAPEUTICS LLC , FLUTAMIDE WELLSTAT THERAP * WELLSTAT THERAPEUTICS CORP VISTOGARD, TRIACETATE XURIDEN, WES PHARMA INC * WES PHARMA INC BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN WEST WARD * WEST WARD PHARMACEUTICAL CORP DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE WEST WARD PHARM CORP * WEST WARD PHARMACEUTICAL CORP ROCURONIUM BROMIDE, ROCURONIUM BROMIDE WEST-WARD PHARMS INT * WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ADENOSINE, ADENOSINE ALLOPURINOL SODIUM, ALLOPURINOL SODIUM ALPROSTADIL, ALPROSTADIL AMIKACIN SULFATE, AMIKACIN SULFATE AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM LACTATE, INAMRINONE LACTATE ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE ATRACURIUM BESYLATE, ATRACURIUM BESYLATE AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM BLEOMYCIN SULFATE, BLEOMYCIN SULFATE BUMETANIDE, BUMETANIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE CARBOPLATIN, CARBOPLATIN CEFOXITIN, CEFOXITIN SODIUM CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE CISPLATIN, CISPLATIN CLADRIBINE, CLADRIBINE CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE CYANOCOBALAMIN, CYANOCOBALAMIN CYCLOSPORINE, CYCLOSPORINE CYTARABINE, CYTARABINE DACARBAZINE, DACARBAZINE DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE), DICYCLOMINE HYDROCHLORIDE DIGOXIN, DIGOXIN DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE DIPYRIDAMOLE, DIPYRIDAMOLE DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE HYCLATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 195 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE ETOMIDATE, ETOMIDATE ETOPOSIDE, ETOPOSIDE FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE FAMOTIDINE, FAMOTIDINE FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE FLOXURIDINE, FLOXURIDINE FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE FLUMAZENIL, FLUMAZENIL FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL, HALOPERIDOL LACTATE IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE IFOSFAMIDE, IFOSFAMIDE INDOMETHACIN SODIUM, INDOMETHACIN SODIUM IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM LEVOCARNITINE, LEVOCARNITINE LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE MESNA, MESNA METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METOPROLOL TARTRATE, METOPROLOL TARTRATE MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE MILRINONE LACTATE, MILRINONE LACTATE MITOMYCIN, MITOMYCIN MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE NALOXONE, NALOXONE HYDROCHLORIDE NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE OCTREOTIDE ACETATE, OCTREOTIDE ACETATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE ORPHENADRINE CITRATE, ORPHENADRINE CITRATE OXYTOCIN, OXYTOCIN PACLITAXEL, PACLITAXEL PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PENTOSTATIN, PENTOSTATIN PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE PHENYTOIN SODIUM, PHENYTOIN SODIUM PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE PROPOFOL, PROPOFOL RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RIFAMPIN, RIFAMPIN SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE SODIUM FERRIC GLUCONATE COMPLEX IN , FERRIC OXYHYDROXIDE STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION SUFENTANIL CITRATE, SUFENTANIL CITRATE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 196 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE THIOTEPA, THIOTEPA TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VECURONIUM BROMIDE, VECURONIUM BROMIDE VINBLASTINE SULFATE, VINBLASTINE SULFATE VINORELBINE TARTRATE, VINORELBINE TARTRATE WILSHIRE PHARMS INC * WILSHIRE PHARMACEUTICALS INC CARISOPRODOL, CARISOPRODOL PERPHENAZINE, PERPHENAZINE TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE WINDER LABS LLC * WINDER LABORATOIRIES LLC DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE MORPHINE SULFATE, MORPHINE SULFATE WISCONSIN * WISCONSIN MEDICAL RADIOPHARMACY LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 WOCKHARDT * WOCKHARDT LTD AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE AZITHROMYCIN, AZITHROMYCIN BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE CEFTRIAXONE, CEFTRIAXONE SODIUM CEFUROXIME AXETIL, CEFUROXIME AXETIL CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC) DIVALPROEX SODIUM, DIVALPROEX SODIUM FAMOTIDINE, FAMOTIDINE (OTC) FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM FUROSEMIDE, FUROSEMIDE KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE LEVETIRACETAM, LEVETIRACETAM METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE WOCKHARDT BIO AG * WOCKHARDT BIO AG ABIRATERONE ACETATE, ABIRATERONE ACETATE ACETIC ACID, ACETIC ACID, GLACIAL AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN AMOXICILLIN, AMOXICILLIN BROMFED-DM, BROMPHENIRAMINE MALEATE CARBAMAZEPINE, CARBAMAZEPINE CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CROMOLYN SODIUM, CROMOLYN SODIUM CYCLOSPORINE, CYCLOSPORINE DECITABINE, DECITABINE DEXAMETHASONE, DEXAMETHASONE DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE ERYTHROMYCIN, ERYTHROMYCIN FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE FUROSEMIDE, FUROSEMIDE GENERLAC, LACTULOSE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 197 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WOCKHARDT BIO AG IMATINIB MESYLATE, IMATINIB MESYLATE LACTULOSE, LACTULOSE LEVETIRACETAM, LEVETIRACETAM LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE , LINDANE LITHIUM CITRATE, LITHIUM CITRATE LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC) LORATADINE, LORATADINE (OTC) MEGESTROL ACETATE, MEGESTROL ACETATE METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE MINOXIDIL (FOR MEN), MINOXIDIL (OTC) MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC) NYSTATIN, NYSTATIN OXACILLIN SODIUM, OXACILLIN SODIUM OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE PHENYTOIN, PHENYTOIN PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE, PREDNISOLONE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE SELENIUM SULFIDE, SELENIUM SULFIDE TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE VALPROIC ACID, VALPROIC ACID WOCKHARDT LTD * WOCKHARDT LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE CAPTOPRIL, CAPTOPRIL CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) ENALAPRIL MALEATE, ENALAPRIL MALEATE FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC) FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC) LANSOPRAZOLE, LANSOPRAZOLE (OTC) OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE WOCKHARDT USA * WOCKHARDT USA INC GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE * WOCKHARDT USA LLC LANSOPRAZOLE, LANSOPRAZOLE WOODWARD * WOODWARD PHARMA SERVICES LLC FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE LOVAZA, OMEGA-3-ACID ETHYL ESTERS MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE WRASER PHARMS * WRASER PHARMACEUTICALS LLC CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE WRASER PHARMS LLC * WRASER PHARMACEUTICALS LLC TREZIX, ACETAMINOPHEN WUSM CYCLOTRON * WASHINGTON UNIV SCH MEDICINE CYCLOTRON FACILITY FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 PHARMS * WYETH PHARMACEUTICALS LLC DUAVEE, ACETATE PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE PREMARIN, ESTROGENS, CONJUGATED PREMPHASE 14/14, ESTROGENS, CONJUGATED PREMPRO, ESTROGENS, CONJUGATED

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 198 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W ** * WYETH PHARMACEUTICALS LLC PROTONIX IV, PANTOPRAZOLE SODIUM PROTONIX, PANTOPRAZOLE SODIUM TRECATOR, ETHIONAMIDE ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

** X ** XELLIA PHARMS APS * XELLIA PHARMACEUTICALS APS CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM DAPTOMYCIN, DAPTOMYCIN MICAFUNGIN SODIUM, MICAFUNGIN SODIUM POLYMYXIN B SULFATE, POLYMYXIN B SULFATE TIGECYCLINE, TIGECYCLINE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE XERIS * XERIS PHARMACEUTICALS INC GVOKE HYPOPEN, GLUCAGON GVOKE PFS, GLUCAGON XGEN PHARMS * XGEN PHARMACEUTICALS DJB INC ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM AMPHOTERICIN B, AMPHOTERICIN B CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM DACTINOMYCIN, DACTINOMYCIN FOLIC ACID, FOLIC ACID IBUPROFEN LYSINE, IBUPROFEN LYSINE LEVETIRACETAM, LEVETIRACETAM LINCOMYCIN, LINCOMYCIN HYDROCHLORIDE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE NEOMYCIN SULFATE, NEOMYCIN SULFATE NYSTATIN, NYSTATIN POLYMYXIN B SULFATE, POLYMYXIN B SULFATE PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE SULFATE, STREPTOMYCIN SULFATE TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE TRANEXAMIC ACID, TRANEXAMIC ACID XIAMEN LP PHARM CO * XIAMEN LP PHARMACUETICAL CO LTD CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE XIROMED * XIROMED PHARMA ESPANA SL ACYCLOVIR, ACYCLOVIR ALTAVERA, ETHINYL ESTRADIOL CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE ESTARYLLA, ETHINYL ESTRADIOL FLUOCINONIDE, FLUOCINONIDE FOSFOMYCIN TROMETHAMINE, FOSFOMYCIN TROMETHAMINE GEMMILY, ETHINYL ESTRADIOL GLYCOPYRROLATE, GLYCOPYRROLATE INTROVALE, ETHINYL ESTRADIOL ISIBLOOM, DESOGESTREL JAIMIESS, ETHINYL ESTRADIOL KETOCONAZOLE, KETOCONAZOLE LANSOPRAZOLE, LANSOPRAZOLE LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL LEVONORGESTREL, LEVONORGESTREL (OTC) LORYNA, DROSPIRENONE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 199 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** X ** * XIROMED PHARMA ESPANA SL MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL OMEPRAZOLE, OMEPRAZOLE PROGESTERONE, PROGESTERONE SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE SYEDA, DROSPIRENONE TESTOSTERONE, TESTOSTERONE TRI-ESTARYLLA, ETHINYL ESTRADIOL TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL VIENVA, ETHINYL ESTRADIOL VOLNEA, DESOGESTREL XSPIRE PHARMA * XSPIRE PHARMA BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN NALFON, FENOPROFEN CALCIUM ZONTIVITY, SULFATE * XSPIRE PHARMA LLC DEXAMETHASONE, DEXAMETHASONE FENOPROFEN CALCIUM, FENOPROFEN CALCIUM XTTRIUM * XTTRIUM LABORATORIES INC CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE EXIDINE, CHLORHEXIDINE GLUCONATE (OTC) XTTRIUM LABS INC * XTTRIUM LABORATORIES INC LACTULOSE, LACTULOSE

** Y ** YABAO PHARM * YABAO PHARMACEUTICAL CO LTD BEIJING GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE YANGLING BUCHANG * YANGLING BUCHANG PHARMACEUTICAL CO LTD TADALAFIL, TADALAFIL YAOPHARMA CO LTD * YAOPHARMA CO LTD VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE YICHANG HUMANWELL * YICHANG HUMANWELL PHARMACEUTICAL CO LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE YILING * YILING PHARMACEUTICAL LTD ACYCLOVIR, ACYCLOVIR AMLODIPINE BESYLATE, AMLODIPINE BESYLATE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CELECOXIB, CELECOXIB CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE FELODIPINE, FELODIPINE LISINOPRIL, LISINOPRIL SILDENAFIL CITRATE, SILDENAFIL CITRATE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE YOUNGTECH PHARMS INC * YOUNGTECH PHARMACEUTICALS INC METOPROLOL TARTRATE, METOPROLOL TARTRATE YUNG SHIN PHARM * YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD AZITHROMYCIN, AZITHROMYCIN

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 200 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Y ** * YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD CEFACLOR, CEFACLOR CEPHALEXIN, CEPHALEXIN CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM FELODIPINE, FELODIPINE MELOXICAM, MELOXICAM

** Z ** ZAMBON SPA * ZAMBON SPA MONUROL, FOSFOMYCIN TROMETHAMINE ZEALAND PHARMA * ZEALAND PHARMA US INC ZEGALOGUE (AUTOINJECTOR), HYDROCHLORIDE ZEGALOGUE, DASIGLUCAGON HYDROCHLORIDE ZENNOVA * ZENNOVA PHARMACEUTICALS CHENGDU CO LTD IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE QUETIAPINE FUMARATE, QUETIAPINE FUMARATE ZHEJIANG HISUN PHARM * ZHEJIANG HISUN PHARMACEUTICAL CO LTD MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL ZHEJIANG JINGXIN * ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE LEVETIRACETAM, LEVETIRACETAM ZHEJIANG JUTAI PHARM * ZHEJIANG JUTAI PHARMACEUTICAL CO LTD BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE ZHEJIANG YONGTAI * ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD GABAPENTIN, GABAPENTIN ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM ZIONEXA * ZIONEXA US CORP CERIANNA, FLUOROESTRADIOL F-18 ZO HEALTH * ZO SKIN HEALTH TRETINOIN, TRETINOIN ZOGENIX INC * ZOGENIX INC FINTEPLA, HYDROCHLORIDE ZYDUS * ZYDUS WORLDWIDE DMCC AZITHROMYCIN, AZITHROMYCIN BACLOFEN, BACLOFEN CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE IBRUTINIB, IBRUTINIB ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE LEFLUNOMIDE, LEFLUNOMIDE LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM MACITENTAN, MACITENTAN MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE PHYTONADIONE, PHYTONADIONE PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE URSODIOL, URSODIOL ZYDUS HLTHCARE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 201 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z ** * ZYDUS HEALTHCARE USA LLC DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE LANSOPRAZOLE, LANSOPRAZOLE METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE ZYDUS NOVELTECH INC * ZYDUS NOVELTECH INC RIVASTIGMINE, RIVASTIGMINE ZYDUS PHARMS * ZYDUS PHARMACEUTICALS USA INC ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM ACETYLCYSTEINE, ACETYLCYSTEINE ACYCLOVIR SODIUM, ACYCLOVIR SODIUM ACYCLOVIR, ACYCLOVIR ALBENDAZOLE, ALBENDAZOLE ALBUTEROL SULFATE, ALBUTEROL SULFATE ALLOPURINOL, ALLOPURINOL AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE AMBRISENTAN, AMBRISENTAN AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE ARIPIPRAZOLE, ARIPIPRAZOLE ARSENIC TRIOXIDE, ARSENIC TRIOXIDE ASPIRIN AND DIPYRIDAMOLE, ASPIRIN ATENOLOL AND CHLORTHALIDONE, ATENOLOL ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE BOSENTAN, BOSENTAN BUDESONIDE, BUDESONIDE BUMETANIDE, BUMETANIDE BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL CARBAMAZEPINE, CARBAMAZEPINE CARBIDOPA, CARBIDOPA CHLORTHALIDONE, CHLORTHALIDONE CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE CHOLESTYRAMINE, CHOLESTYRAMINE CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE CLOBAZAM, CLOBAZAM CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE COLCHICINE, COLCHICINE COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE DEFERASIROX, DEFERASIROX DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DIFLUNISAL, DIFLUNISAL DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DOXYCYCLINE, DOXYCYCLINE DOXYCYCLINE, DOXYCYCLINE HYCLATE DROXIDOPA, DROXIDOPA DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 202 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z ** * ZYDUS PHARMACEUTICALS USA INC EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM ENTECAVIR, ENTECAVIR ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM ETHACRYNATE SODIUM, ETHACRYNATE SODIUM ETODOLAC, ETODOLAC ETOMIDATE, ETOMIDATE EXEMESTANE, EXEMESTANE EZETIMIBE, EZETIMIBE FESOTERODINE FUMARATE, FESOTERODINE FUMARATE FLUCONAZOLE, FLUCONAZOLE FLUOCINONIDE, FLUOCINONIDE GLIPIZIDE, GLIPIZIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GLYBURIDE, GLYBURIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE IMATINIB MESYLATE, IMATINIB MESYLATE INDOMETHACIN, INDOMETHACIN ITRACONAZOLE, ITRACONAZOLE LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE LAMOTRIGINE, LAMOTRIGINE LANSOPRAZOLE, LANSOPRAZOLE LINEZOLID, LINEZOLID MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE MESALAMINE, MESALAMINE METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLPREDNISOLONE, METHYLPREDNISOLONE METOPROLOL SUCCINATE, METOPROLOL SUCCINATE MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE MIRTAZAPINE, MIRTAZAPINE MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE NADOLOL, NADOLOL NATEGLINIDE, NATEGLINIDE NIFEDIPINE, NIFEDIPINE NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE OLANZAPINE, OLANZAPINE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC) OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PERPHENAZINE, PERPHENAZINE PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE POTASSIUM CHLORIDE, POTASSIUM CHLORIDE POTASSIUM CITRATE, POTASSIUM CITRATE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE RAMELTEON, RAMELTEON SEVELAMER CARBONATE, SEVELAMER CARBONATE SIROLIMUS, SIROLIMUS SPIRONOLACTONE, SPIRONOLACTONE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TADALAFIL, TADALAFIL TAMOXIFEN CITRATE, TAMOXIFEN CITRATE TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TELMISARTAN, TELMISARTAN TEMOZOLOMIDE, TEMOZOLOMIDE TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 203 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z ** * ZYDUS PHARMACEUTICALS USA INC VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE VORICONAZOLE, VORICONAZOLE ZOLMITRIPTAN, ZOLMITRIPTAN ZYDUS PHARMS USA * ZYDUS PHARMACEUTICALS USA INC AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ATENOLOL, ATENOLOL AZATHIOPRINE, AZATHIOPRINE BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE BENZONATATE, BENZONATATE CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE HALOPERIDOL, HALOPERIDOL LAMOTRIGINE, LAMOTRIGINE MELOXICAM, MELOXICAM METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE NAPROXEN, NAPROXEN PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE RAMIPRIL, RAMIPRIL RIBAVIRIN, RIBAVIRIN RISPERIDONE, RISPERIDONE SIMVASTATIN, SIMVASTATIN VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE WARFARIN SODIUM, WARFARIN SODIUM ZONISAMIDE, ZONISAMIDE ZYDUS PHARMS USA INC * ZYDUS PHARMACEUTICALS USA INC AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE ANASTROZOLE, ANASTROZOLE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE BICALUTAMIDE, BICALUTAMIDE BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE CARVEDILOL, CARVEDILOL DIPYRIDAMOLE, DIPYRIDAMOLE DIVALPROEX SODIUM, DIVALPROEX SODIUM FINASTERIDE, FINASTERIDE GABAPENTIN, GABAPENTIN GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IRBESARTAN, IRBESARTAN LAMOTRIGINE, LAMOTRIGINE LEVETIRACETAM, LEVETIRACETAM LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, LOSARTAN POTASSIUM OMEPRAZOLE, OMEPRAZOLE PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE RISPERIDONE, RISPERIDONE TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE TOPIRAMATE, TOPIRAMATE TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE ZOLMITRIPTAN, ZOLMITRIPTAN ZYLA * ZYLA LIFE SCIENCES US INC OXAYDO, OXYCODONE HYDROCHLORIDE SPRIX, KETOROLAC TROMETHAMINE ZORVOLEX, DICLOFENAC