Appendix B - Product Name Sorted by Applicant
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JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 1 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** 3 ** 3D IMAGING DRUG * 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC AMMONIA N 13, AMMONIA N-13 FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18 SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18 3M * 3M CO PERIDEX, CHLORHEXIDINE GLUCONATE * 3M HEALTH CARE INC AVAGARD, ALCOHOL (OTC) DURAPREP, IODINE POVACRYLEX (OTC) 3M HEALTH CARE * 3M HEALTH CARE INFECTION PREVENTION DIV SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC) ** 6 ** 60 DEGREES PHARMS * 60 DEGREES PHARMACEUTICALS LLC ARAKODA, TAFENOQUINE 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, AZATHIOPRINE ABBVIE * ABBVIE INC ANDROGEL, TESTOSTERONE CYCLOSPORINE, CYCLOSPORINE DEPAKOTE ER, DIVALPROEX SODIUM DEPAKOTE, DIVALPROEX SODIUM GENGRAF, CYCLOSPORINE K-TAB, POTASSIUM CHLORIDE KALETRA, LOPINAVIR NIASPAN, NIACIN NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE NIMBEX, CISATRACURIUM BESYLATE NORVIR, RITONAVIR SYNTHROID, LEVOTHYROXINE SODIUM ** TARKA, TRANDOLAPRIL TRICOR, FENOFIBRATE TRILIPIX, CHOLINE FENOFIBRATE ULTANE, SEVOFLURANE ZEMPLAR, PARICALCITOL ABBVIE ENDOCRINE * ABBVIE ENDOCRINE INC LUPANETA PACK, LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC * ABBVIE ENDOCRINE INC LUPRON DEPOT, LEUPROLIDE ACETATE LUPRON DEPOT-PED KIT, LEUPROLIDE ACETATE ABBVIE INC * ABBVIE INC DUOPA, CARBIDOPA MAVYRET, GLECAPREVIR NORVIR, RITONAVIR ORIAHNN (COPACKAGED), ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE ORILISSA, ELAGOLIX SODIUM RINVOQ, UPADACITINIB VENCLEXTA, VENETOCLAX 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 METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE ABHAI LLC * ABHAI LLC ATOVAQUONE, ATOVAQUONE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE LEFLUNOMIDE, LEFLUNOMIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE URSODIOL, URSODIOL ABON PHARMS LLC * ABON PHARMACEUTICALS LLC CLOFARABINE, CLOFARABINE ABRAXIS BIOSCIENCE * ABRAXIS BIOSCIENCE LLC ABRAXANE, PACLITAXEL ABRAXIS PHARM * ABRAXIS PHARMACEUTICAL PRODUCTS CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE ACACIA * ACACIA PHARMA LTD BARHEMSYS, AMISULPRIDE BYFAVO, REMIMAZOLAM BESYLATE ACADIA PHARMS INC * ACADIA PHARMACEUTICALS INC NUPLAZID, PIMAVANSERIN TARTRATE ACCELRX LABS * ACCELRX LABS LLC CARISOPRODOL, CARISOPRODOL ACCORD HLTHCARE * ACCORD HEALTHCARE INC ACETAZOLAMIDE, ACETAZOLAMIDE ALLOPURINOL, ALLOPURINOL AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE, AMLODIPINE BESYLATE ANASTROZOLE, ANASTROZOLE APIXABAN, APIXABAN ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN ARIPIPRAZOLE, ARIPIPRAZOLE ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM ATROPINE SULFATE, ATROPINE SULFATE AZACITIDINE, AZACITIDINE BICALUTAMIDE, BICALUTAMIDE BIVALIRUDIN, BIVALIRUDIN BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE CAPECITABINE, CAPECITABINE CARBIDOPA AND LEVODOPA, CARBIDOPA CARBOPLATIN, CARBOPLATIN CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE CISPLATIN, CISPLATIN CLOFARABINE, CLOFARABINE CLONAZEPAM, CLONAZEPAM CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE CLOZAPINE, CLOZAPINE DALFAMPRIDINE, DALFAMPRIDINE DAPTOMYCIN, DAPTOMYCIN DECITABINE, DECITABINE JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 3 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ACCORD HEALTHCARE INC DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DIMETHYL FUMARATE, DIMETHYL FUMARATE DOCETAXEL, DOCETAXEL DOFETILIDE, DOFETILIDE DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE ENTECAVIR, ENTECAVIR EPLERENONE, EPLERENONE EPTIFIBATIDE, EPTIFIBATIDE ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM ETOPOSIDE, ETOPOSIDE EZETIMIBE, EZETIMIBE FINASTERIDE, FINASTERIDE FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE FLUOROURACIL, FLUOROURACIL FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE FULVESTRANT, FULVESTRANT FUROSEMIDE, FUROSEMIDE GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE GLIMEPIRIDE, GLIMEPIRIDE GLIPIZIDE, GLIPIZIDE GLYCOPYRROLATE, GLYCOPYRROLATE HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE IBANDRONATE SODIUM, IBANDRONATE SODIUM IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE ITRACONAZOLE, ITRACONAZOLE LETROZOLE, LETROZOLE LEVETIRACETAM, LEVETIRACETAM LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ** LISINOPRIL, LISINOPRIL LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METHYLDOPA, METHYLDOPA METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE MITOMYCIN, MITOMYCIN MONTELUKAST SODIUM, MONTELUKAST SODIUM MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL MYCOPHENOLIC ACID, MYCOPHENOLIC ACID NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE OXALIPLATIN, OXALIPLATIN OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE PACLITAXEL, PACLITAXEL PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE PARICALCITOL, PARICALCITOL PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE PRASUGREL, PRASUGREL HYDROCHLORIDE PRAVASTATIN SODIUM, PRAVASTATIN SODIUM QUETIAPINE FUMARATE, QUETIAPINE FUMARATE RAMIPRIL, RAMIPRIL RANOLAZINE, RANOLAZINE ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE SIMVASTATIN, SIMVASTATIN SPIRONOLACTONE, SPIRONOLACTONE SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE TACROLIMUS, TACROLIMUS JUNE 2021 - APPROVED DRUG PRODUCT LIST B - 4 APPENDIX B - PRODUCT NAME SORTED BY APPLICANT ** A ** * ACCORD HEALTHCARE INC TADALAFIL, TADALAFIL TEMOZOLOMIDE, TEMOZOLOMIDE TEMSIROLIMUS, TEMSIROLIMUS TERIFLUNOMIDE, TERIFLUNOMIDE TOPIRAMATE, TOPIRAMATE TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE VIGABATRIN, VIGABATRIN VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE ZOLEDRONIC ACID, ZOLEDRONIC ACID ACCORD HLTHCARE INC * ACCORD HEALTHCARE INC USA BUSULFAN, BUSULFAN TIGECYCLINE, TIGECYCLINE ACELLA * ACELLA PHARMACEUTICALS LLC BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN CICLOPIROX, CICLOPIROX DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DUTASTERIDE, DUTASTERIDE NIFEDIPINE, NIFEDIPINE PHENYTOIN SODIUM, PHENYTOIN SODIUM ACELLA PHARMS LLC * ACELLA PHARMACEUTICALS LLC GABAPENTIN, GABAPENTIN ACELRX PHARMS * ACELRX PHARMACEUTICALS INC DSUVIA, SUFENTANIL 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 TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE ACIC PHARMS * ACIC PHARMACEUTICALS INC TRANEXAMIC ACID, TRANEXAMIC ACID ACORDA * ACORDA THERAPEUTICS INC AMPYRA, DALFAMPRIDINE INBRIJA, LEVODOPA ACROTECH * ACROTECH BIOPHARMA LLC BELEODAQ, BELINOSTAT EVOMELA, MELPHALAN HYDROCHLORIDE FOLOTYN, PRALATREXATE FUSILEV, LEVOLEUCOVORIN CALCIUM KHAPZORY, LEVOLEUCOVORIN MARQIBO KIT, VINCRISTINE SULFATE ACRUX DDS * ACRUX DDS PTY LTD EFINACONAZOLE, EFINACONAZOLE ACS DOBFAR * ACS DOBFAR SPA AMPICILLIN 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 IMIPENEM AND CILASTATIN, CILASTATIN SODIUM MEROPENEM, MEROPENEM ACS DOBFAR SPA * ACS DOBFAR SPA AMPICILLIN SODIUM, AMPICILLIN SODIUM CEFUROXIME SODIUM, CEFUROXIME SODIUM ERTAPENEM SODIUM, ERTAPENEM SODIUM MEROPENEM, MEROPENEM PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM ACTAVIS ELIZABETH * ACTAVIS ELIZABETH LLC ALBENDAZOLE, ALBENDAZOLE ALPRAZOLAM, ALPRAZOLAM BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE CARBIDOPA AND LEVODOPA, CARBIDOPA CLONAZEPAM, CLONAZEPAM CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE DEFERASIROX, DEFERASIROX DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, DEXTROMETHORPHAN HYDROBROMIDE DICLOFENAC SODIUM, DICLOFENAC SODIUM DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE FENOFIBRIC ACID, CHOLINE FENOFIBRATE FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE GABAPENTIN, GABAPENTIN GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE GUANFACINE HYDROCHLORIDE, GUANFACINE