Prescription and Over-the-Counter Drug Product List 39TH EDITION Cumulative Supplement Number 08 : August 2019 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE TABLET;ORAL APADAZ >D> + KVK TECH INC 325MG;EQ 8.16MG BASE N 208653 003 Jan 04, 2019 Aug CHRS >A> +! 325MG;EQ 8.16MG BASE N 208653 003 Jan 04, 2019 Aug CHRS ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >A> AA ELITE LABS INC 300MG;15MG A 212418 001 Sep 10, 2019 Aug NEWA >A> AA 300MG;30MG A 212418 002 Sep 10, 2019 Aug NEWA >A> AA 300MG;60MG A 212418 003 Sep 10, 2019 Aug NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL OXYCODONE AND ACETAMINOPHEN >D> AA CHEMO RESEARCH SL 325MG;5MG A 207574 001 Dec 13, 2016 Aug CAHN >A> AA HALO PHARM CANADA 325MG;5MG A 207834 001 Aug 15, 2019 Aug NEWA >A> AA 325MG;7.5MG A 207834 002 Aug 15, 2019 Aug NEWA >A> AA 325MG;10MG A 207834 003 Aug 15, 2019 Aug NEWA >A> AA XIROMED 325MG;5MG A 207574 001 Dec 13, 2016 Aug CAHN ACYCLOVIR CAPSULE;ORAL ACYCLOVIR >A> AB CADILA 200MG A 204313 001 Mar 25, 2016 Aug CAHN >D> AB ZYDUS PHARMS 200MG A 204313 001 Mar 25, 2016 Aug CAHN >D> OINTMENT;OPHTHALMIC >D> AVACLYR >D> +! FERA PHARMS LLC 3% N 202408 001 Mar 29, 2019 Aug DISC >A> + @ 3% N 202408 001 Mar 29, 2019 Aug DISC OINTMENT;TOPICAL ACYCLOVIR >A> AB APOTEX INC 5% A 210774 001 Sep 06, 2019 Aug NEWA >D> AB PERRIGO UK FINCO 5% A 205659 001 Feb 20, 2019 Aug DISC >A> @ 5% A 205659 001 Feb 20, 2019 Aug DISC ALBENDAZOLE TABLET;ORAL ALBENDAZOLE >A> AB STRIDES PHARMA 200MG A 210011 001 Dec 07, 2018 Aug CAHN >D> AB STRIDES VIVIMED 200MG A 210011 001 Dec 07, 2018 Aug CAHN ALBUTEROL SULFATE SYRUP;ORAL ALBUTEROL SULFATE >A> AA QUAGEN EQ 2MG BASE/5ML A 212197 001 Sep 06, 2019 Aug NEWA AMINOCAPROIC ACID SYRUP;ORAL AMICAR >D> +! CLOVER PHARMS 1.25GM/5ML N 015230 002 Oct 26, 1970 Aug CTEC >A> AA +! 1.25GM/5ML N 015230 002 Oct 26, 1970 Aug CTEC AMINOCAPROIC ACID >A> AA AMNEAL PHARMS LLC 1.25GM/5ML A 212780 001 Aug 23, 2019 Aug NEWA ARSENIC TRIOXIDE INJECTABLE;INJECTION ARSENIC TRIOXIDE >A> AP ZYDUS PHARMS 2MG/ML A 206228 002 Aug 30, 2019 Aug NFTG TRISENOX >D> +! CEPHALON 2MG/ML N 021248 002 Oct 13, 2017 Aug CFTG >A> AP +! 2MG/ML N 021248 002 Oct 13, 2017 Aug CFTG Page 1 of 30 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL BUTALBITAL, ASPIRIN AND CAFFEINE >A> AA BRECKENRIDGE 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Aug CAHN >D> AA PII 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Aug CAHN AZELAIC ACID GEL;TOPICAL AZELAIC ACID >A> AB TARO 15% A 210549 001 Aug 23, 2019 Aug NEWA AZELASTINE HYDROCHLORIDE SPRAY, METERED;NASAL AZELASTINE HYDROCHLORIDE >A> AB HI TECH EQ 0.1876MG BASE/SPRAY A 210032 001 Aug 23, 2019 Aug NEWA BACLOFEN INJECTABLE;INTRATHECAL BACLOFEN >A> AP MAIA PHARMS INC 0.5MG/ML A 210048 001 Sep 11, 2019 Aug NEWA >A> AP 2MG/ML A 210048 002 Sep 11, 2019 Aug NEWA GABLOFEN >D> AP PIRAMAL CRITICAL 0.05MG/ML N 022462 001 Nov 19, 2010 Aug CAHN >A> AP 0.05MG/ML N 022462 001 Nov 19, 2010 Aug CAHN >D> AP 0.5MG/ML N 022462 002 Nov 19, 2010 Aug CAHN >A> AP 0.5MG/ML N 022462 002 Nov 19, 2010 Aug CAHN >D> AP +! 1MG/ML N 022462 004 Jun 22, 2012 Aug CAHN >A> AP +! 1MG/ML N 022462 004 Jun 22, 2012 Aug CAHN >D> AP 2MG/ML N 022462 003 Nov 19, 2010 Aug CAHN >A> AP 2MG/ML N 022462 003 Nov 19, 2010 Aug CAHN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL ACANYA >A> AB +! BAUSCH 2.5%;EQ 1.2% BASE N 050819 001 Oct 23, 2008 Aug CAHN >D> AB +! DOW PHARM 2.5%;EQ 1.2% BASE N 050819 001 Oct 23, 2008 Aug CAHN BENZACLIN >A> AB +! BAUSCH 5%;EQ 1% BASE N 050756 001 Dec 21, 2000 Aug CAHN >A> @ 5%;EQ 1% BASE N 050756 002 Apr 20, 2007 Aug CAHN >D> AB +! VALEANT BERMUDA 5%;EQ 1% BASE N 050756 001 Dec 21, 2000 Aug CAHN >D> @ 5%;EQ 1% BASE N 050756 002 Apr 20, 2007 Aug CAHN CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE >A> AB PERRIGO ISRAEL 2.5%;EQ 1.2% BASE A 205397 001 Sep 09, 2019 Aug NEWA >A> AB TARO 2.5%;EQ 1.2% BASE A 206575 001 Aug 19, 2019 Aug NEWA >A> AB TOLMAR 2.5%;EQ 1.2% BASE A 207194 001 Aug 19, 2019 Aug NEWA ONEXTON >A> +! BAUSCH 3.75%;EQ 1.2% BASE N 050819 002 Nov 24, 2014 Aug CAHN >D> +! DOW PHARM 3.75%;EQ 1.2% BASE N 050819 002 Nov 24, 2014 Aug CAHN BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL >D> AKTIPAK >D> +! BIOFRONTERA 5%;3% N 050769 001 Nov 27, 2000 Aug DISC >A> + @ 5%;3% N 050769 001 Nov 27, 2000 Aug DISC BRETYLIUM TOSYLATE INJECTABLE;INJECTION BRETYLIUM TOSYLATE >D> ! BAS ANDA 50MG/ML A 204386 001 Dec 21, 2018 Aug CAHN >A> ! BRECKENRIDGE 50MG/ML A 204386 001 Dec 21, 2018 Aug CAHN BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL BUPROPION HYDROCHLORIDE >A> AB3 ZHEJIANG JUTAI PHARM 300MG A 211200 001 Sep 05, 2019 Aug NEWA Page 2 of 30 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST BUSPIRONE HYDROCHLORIDE TABLET;ORAL BUSPIRONE HYDROCHLORIDE >D> @ APOTEX 5MG A 075521 001 Apr 05, 2002 Aug CAHN >D> @ 10MG A 075521 002 Apr 05, 2002 Aug CAHN >D> @ 15MG A 075521 003 Apr 05, 2002 Aug CAHN >A> @ RUBICON 5MG A 075521 001 Apr 05, 2002 Aug CAHN >A> @ 10MG A 075521 002 Apr 05, 2002 Aug CAHN >A> @ 15MG A 075521 003 Apr 05, 2002 Aug CAHN CABERGOLINE TABLET;ORAL CABERGOLINE >D> AB ACTAVIS LABS FL INC 0.5MG A 078035 001 Apr 21, 2008 Aug DISC >A> @ 0.5MG A 078035 001 Apr 21, 2008 Aug DISC CAFFEINE CITRATE SOLUTION;INTRAVENOUS CAFCIT >A> AP +! HIKMA EQ 30MG BASE/3ML (EQ 10MG N 020793 001 Sep 21, 1999 Aug CAHN BASE/ML) >D> AP +! WEST-WARD PHARMS INT EQ 30MG BASE/3ML (EQ 10MG N 020793 001 Sep 21, 1999 Aug CAHN BASE/ML) SOLUTION;ORAL CAFCIT >A> AA +! HIKMA EQ 30MG BASE/3ML (EQ 10MG N 020793 002 Apr 12, 2000 Aug CAHN BASE/ML) >D> AA +! WEST-WARD PHARMS INT EQ 30MG BASE/3ML (EQ 10MG N 020793 002 Apr 12, 2000 Aug CAHN BASE/ML) CALCITONIN SALMON INJECTABLE;INJECTION MIACALCIN >D> @ MYLAN IRELAND LTD 100 IU/ML N 017808 001 Jul 03, 1986 Aug CRLD >A> + @ 100 IU/ML N 017808 001 Jul 03, 1986 Aug CRLD CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER >D> + BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG N 020183 002 Dec 04, 1992 Aug CTEC /100ML;538MG/100ML;448MG/100ML >A> AT + 18.3MG/100ML;2.5GM/100ML;5.08MG N 020183 002 Dec 04, 1992 Aug CTEC /100ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER >D> + BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08M N 020183 004 Dec 04, 1992 Aug CTEC G/100ML;538MG/100ML;448MG/100ML >A> AT + 18.3MG/100ML;4.25GM/100ML;5.08M N 020183 004 Dec 04, 1992 Aug CTEC G/100ML;538MG/100ML;448MG/100ML >A> DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER >A> AT + BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG N 017512 012 Jan 10, 1989 Aug NEWA /100ML;538MG/100ML;448MG/100ML >A> DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER >A> AT + BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG N 017512 013 Jul 11, 1990 Aug NEWA /100ML;538MG/100ML;448MG/100ML >A> DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER >A> AT + BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG N 017512 014 Jul 11, 1990 Aug NEWA /100ML;538MG/100ML;448MG/100ML >A> DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER >A> AT + BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08M N 017512 015 Jul 11, 1990 Aug NEWA G/100ML;538MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER >D> AT + BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG N 017512 004 Oct 05, 1981 Aug CPOT /100ML;538MG/100ML;448MG/100ML >A> AT + 25.7MG/100ML;1.5GM/100ML;5.08MG N 017512 004 Oct 05, 1981 Aug CPOT /100ML;538MG/100ML;448MG/100ML Page 3 of 30 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL CARBIDOPA, LEVODOPA AND ENTACAPONE >D> AB WOCKHARDT LTD 12.5MG;200MG;50MG A 090786 001 Nov 20, 2012 Aug DISC >A> @ 12.5MG;200MG;50MG A 090786 001 Nov 20, 2012 Aug DISC >D> AB 18.75MG;200MG;75MG A 090833 001 Nov 20, 2012 Aug DISC >A> @ 18.75MG;200MG;75MG A 090833 001 Nov 20, 2012 Aug DISC >D> AB 25MG;200MG;100MG A 090833 002 Nov 20, 2012 Aug DISC >A> @ 25MG;200MG;100MG A 090833 002 Nov 20, 2012 Aug DISC >D> AB 31.25MG;200MG;125MG A 090833 003 Nov 20, 2012 Aug DISC >A> @ 31.25MG;200MG;125MG A 090833 003 Nov 20, 2012 Aug DISC >D> AB 37.5MG;200MG;150MG A 090833 004 Nov 20, 2012 Aug DISC >A> @ 37.5MG;200MG;150MG A 090833 004 Nov 20, 2012 Aug DISC >D> AB 50MG;200MG;200MG A 090833 005 Nov 20, 2012 Aug DISC >A> @ 50MG;200MG;200MG A 090833 005 Nov 20, 2012 Aug DISC STALEVO 125 >D> AB + ORION PHARMA 31.25MG;200MG;125MG N 021485 006 Aug 29, 2008 Aug CTEC >A> + 31.25MG;200MG;125MG N 021485 006 Aug 29, 2008 Aug CTEC STALEVO 200 >D> AB +! ORION PHARMA 50MG;200MG;200MG N 021485 004 Aug 02, 2007 Aug CTEC >A> +! 50MG;200MG;200MG N 021485 004 Aug 02, 2007 Aug CTEC STALEVO 50 >D> AB +! ORION PHARMA 12.5MG;200MG;50MG N 021485 001 Jun 11, 2003 Aug CTEC >A> +! 12.5MG;200MG;50MG N 021485 001 Jun 11, 2003 Aug CTEC STALEVO 75 >D> AB + ORION PHARMA 18.75MG;200MG;75MG N 021485 005 Aug 29, 2008 Aug CTEC >A> + 18.75MG;200MG;75MG N 021485 005 Aug 29, 2008 Aug CTEC CARFILZOMIB POWDER;INTRAVENOUS >A> CARFILZOMIB >A> AP DR REDDYS 60MG/VIAL A 209422 001 Sep 09, 2019 Aug NFTG KYPROLIS >D> +! ONYX THERAP 60MG/VIAL N 202714 001 Jul 20, 2012 Aug CFTG >A> AP +! 60MG/VIAL N 202714 001 Jul 20, 2012 Aug CFTG CARISOPRODOL TABLET;ORAL CARISOPRODOL >D> @ ALLIED 350MG A 040245 001 Sep 08, 1997 Aug CMFD >A> AA 350MG A 040245 001 Sep 08, 1997 Aug CMFD CARVEDILOL TABLET;ORAL CARVEDILOL >D> AB APOTEX INC 3.125MG A 078165 001 Sep 05, 2007 Aug CAHN >D> AB 6.25MG A 078165 002 Sep 05, 2007 Aug CAHN >D> AB 12.5MG A 078165 003 Sep 05,