Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
October 2020

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on October 19, 2020.

Month: Year:

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
10/01/2020	ROWASA NDA #019618	SUPPL-26	MESALAMINE	MYLAN SPECIALITY LP	Labeling	Approval
10/01/2020	SFROWASA NDA #019618	SUPPL-26	MESALAMINE	MYLAN SPECIALITY LP	Labeling	Approval
10/01/2020	ASACOL NDA #019651	SUPPL-28	MESALAMINE	APIL	Labeling	Approval
10/01/2020	PENTASA NDA #020049	SUPPL-33	MESALAMINE	TAKEDA PHARMS USA	Labeling	Approval
10/01/2020	COLAZAL NDA #020610	SUPPL-23	BALSALAZIDE DISODIUM	VALEANT PHARMS INTL	Labeling	Approval
10/01/2020	CANASA NDA #021252	SUPPL-25	MESALAMINE	ALLERGAN	Labeling	Approval
10/01/2020	CYMBALTA NDA #021427	SUPPL-53	DULOXETINE HYDROCHLORIDE	LILLY	Labeling	Approval
10/01/2020	ASACOL HD NDA #021830	SUPPL-16	MESALAMINE	APIL	Labeling	Approval
10/01/2020	LIALDA NDA #022000	SUPPL-20	MESALAMINE	TAKEDA PHARMS USA	Labeling	Approval
10/01/2020	GIAZO NDA #022205	SUPPL-4	BALSALAZIDE DISODIUM	VALEANT PHARMS INTL	Labeling	Approval
10/01/2020	APRISO NDA #022301	SUPPL-15	MESALAMINE	VALEANT PHARMS INTL	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-20	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-21	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-23	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-24	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-25	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078235	SUPPL-29	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-12	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-13	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-15	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-16	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-17	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	TOPIRAMATE ANDA #078877	SUPPL-20	TOPIRAMATE	ZYDUS PHARMS USA INC	Labeling	Approval
10/01/2020	ALFUZOSIN HYDROCHLORIDE ANDA #079057	SUPPL-18	ALFUZOSIN HYDROCHLORIDE	SUN PHARM	Labeling	Approval
10/01/2020	BETASERON BLA #103471	SUPPL-5197	INTERFERON BETA-1B	BAYER HEALTHCARE PHARMS		Approval
10/01/2020	DEXLANSOPRAZOLE ANDA #202294	SUPPL-1	DEXLANSOPRAZOLE	PAR PHARM INC	Labeling	Approval
10/01/2020	DELZICOL NDA #204412	SUPPL-12	MESALAMINE	APIL	Labeling	Approval
10/01/2020	ACETAZOLAMIDE ANDA #207401	ORIG-1	ACETAZOLAMIDE	MICRO LABS LTD INDIA		Approval
10/01/2020	MIDODRINE HYDROCHLORIDE ANDA #207849	ORIG-1	MIDODRINE HYDROCHLORIDE	CEROVENE INC		Approval
10/02/2020	SABRIL NDA #020427	SUPPL-24	VIGABATRIN	LUNDBECK PHARMS LLC	REMS	Approval
10/02/2020	SABRIL NDA #022006	SUPPL-25	VIGABATRIN	LUNDBECK PHARMS LLC	REMS	Approval
10/02/2020	AZOR NDA #022100	SUPPL-39	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	DAIICHI SANKYO	Labeling	Approval
10/02/2020	GALANTAMINE HYDROBROMIDE ANDA #078898	SUPPL-9	GALANTAMINE HYDROBROMIDE	ZYDUS PHARMS USA INC	Labeling	Approval
10/02/2020	LORAZEPAM ANDA #091383	SUPPL-2	LORAZEPAM	AMNEAL PHARMS	Labeling	Approval
10/02/2020	LORAZEPAM ANDA #091383	SUPPL-4	LORAZEPAM	AMNEAL PHARMS	Labeling	Approval
10/02/2020	MONTELUKAST SODIUM ANDA #091576	SUPPL-18	MONTELUKAST SODIUM	VINTAGE PHARMS LLC	Labeling	Approval
10/02/2020	MONTELUKAST SODIUM ANDA #091576	SUPPL-20	MONTELUKAST SODIUM	VINTAGE PHARMS LLC	Labeling	Approval
10/02/2020	MONTELUKAST SODIUM ANDA #091588	SUPPL-17	MONTELUKAST SODIUM	VINTAGE PHARMS LLC	Labeling	Approval
10/02/2020	MONTELUKAST SODIUM ANDA #091588	SUPPL-19	MONTELUKAST SODIUM	VINTAGE PHARMS LLC	Labeling	Approval
10/02/2020	EXTAVIA BLA #125290	SUPPL-70	INTERFERON BETA-1B	NOVARTIS PHARMS		Approval
10/02/2020	YERVOY BLA #125377	SUPPL-115	IPILIMUMAB	BRISTOL MYERS SQUIBB		Approval
10/02/2020	KEYTRUDA BLA #125514	SUPPL-70	PEMBROLIZUMAB	MERCK SHARP DOHME		Approval
10/02/2020	OPDIVO BLA #125554	SUPPL-89	NIVOLUMAB	BRISTOL MYERS SQUIBB		Approval
10/02/2020	TRIBENZOR NDA #200175	SUPPL-33	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	DAIICHI SANKYO	Labeling	Approval
10/02/2020	ZYTIGA NDA #202379	SUPPL-31	ABIRATERONE ACETATE	JANSSEN BIOTECH	Labeling	Approval
10/02/2020	ZYTIGA NDA #202379	SUPPL-33	ABIRATERONE ACETATE	JANSSEN BIOTECH	Labeling	Approval
10/02/2020	GATIFLOXACIN ANDA #202653	SUPPL-7	GATIFLOXACIN	LUPIN LTD	Labeling	Approval
10/02/2020	GATIFLOXACIN ANDA #203189	SUPPL-1	GATIFLOXACIN	HI-TECH PHARMA CO	Labeling	Approval
10/02/2020	OMEGA-3-ACID ETHYL ESTERS ANDA #203893	SUPPL-14	OMEGA-3-ACID ETHYL ESTERS	STRIDES PHARMA	Manufacturing (CMC)	Approval
10/02/2020	OMEGA-3-ACID ETHYL ESTERS ANDA #203893	SUPPL-15	OMEGA-3-ACID ETHYL ESTERS	STRIDES PHARMA	Labeling	Approval
10/02/2020	GABAPENTIN ANDA #207099	SUPPL-1	GABAPENTIN	EPIC PHARMA LLC	Labeling	Approval
10/02/2020	GABAPENTIN ANDA #207099	SUPPL-2	GABAPENTIN	EPIC PHARMA LLC	Labeling	Approval
10/02/2020	VIGABATRIN ANDA #208218	SUPPL-11	VIGABATRIN	PAR PHARM INC	REMS	Approval
10/02/2020	VIGABATRIN ANDA #209822	SUPPL-8	VIGABATRIN	TEVA PHARMS USA	REMS	Approval
10/02/2020	VIGABATRIN ANDA #209824	SUPPL-9	VIGABATRIN	TEVA PHARMS USA	REMS	Approval
10/02/2020	VIGABATRIN ANDA #210155	SUPPL-10	VIGABATRIN	AMNEAL PHARMS	REMS	Approval
10/02/2020	VIGADRONE ANDA #210196	SUPPL-7	VIGABATRIN	AUCTA	REMS	Approval
10/02/2020	VIGABATRIN ANDA #211481	SUPPL-6	VIGABATRIN	DR REDDYS LABS LTD	REMS	Approval
10/02/2020	VIGABATRIN ANDA #211592	SUPPL-4	VIGABATRIN	INVAGEN PHARMS	REMS	Approval
10/02/2020	ESOMEPRAZOLE MAGNESIUM ANDA #212949	ORIG-1	ESOMEPRAZOLE MAGNESIUM	CSPC OUYI		Approval
10/02/2020	LAMPIT NDA #213464	SUPPL-1	NIFURTIMOX	BAYER HEALTHCARE	Labeling	Approval
10/02/2020	VIGABATRIN ANDA #213469	SUPPL-1	VIGABATRIN	GRANULES PHARMS	REMS	Approval
10/02/2020	CLOMIPRAMINE HYDROCHLORIDE ANDA #213897	ORIG-1	CLOMIPRAMINE HYDROCHLORIDE	AJANTA PHARMA LTD		Approval
10/05/2020	ERAXIS NDA #021632	SUPPL-30	ANIDULAFUNGIN	VICURON	Labeling	Approval
10/05/2020	MONTELUKAST SODIUM ANDA #090984	SUPPL-11	MONTELUKAST SODIUM	TORRENT PHARMS LTD	Labeling	Approval
10/05/2020	MONTELUKAST SODIUM ANDA #090984	SUPPL-13	MONTELUKAST SODIUM	TORRENT PHARMS LTD	Labeling	Approval
10/05/2020	TYSABRI BLA #125104	SUPPL-971	NATALIZUMAB	BIOGEN IDEC		Approval
10/05/2020	MONTELUKAST SODIUM ANDA #201515	SUPPL-13	MONTELUKAST SODIUM	TORRENT PHARMS LTD	Labeling	Approval
10/05/2020	MONTELUKAST SODIUM ANDA #201515	SUPPL-16	MONTELUKAST SODIUM	TORRENT PHARMS LTD	Labeling	Approval
10/06/2020	PHENYTOIN SODIUM ANDA #040573	SUPPL-12	PHENYTOIN SODIUM	ACELLA	Labeling	Approval
10/06/2020	GEMCITABINE HYDROCHLORIDE ANDA #090799	SUPPL-14	GEMCITABINE HYDROCHLORIDE	FRESENIUS KABI USA	Labeling	Approval
10/06/2020	GEMCITABINE HYDROCHLORIDE ANDA #090799	SUPPL-15	GEMCITABINE HYDROCHLORIDE	FRESENIUS KABI USA	Labeling	Approval
10/06/2020	RIZATRIPTAN BENZOATE ANDA #202490	SUPPL-8	RIZATRIPTAN BENZOATE	AUROBINDO PHARMA LTD	Labeling	Approval
10/06/2020	DOXYCYCLINE HYCLATE ANDA #209987	ORIG-1	DOXYCYCLINE HYCLATE	MYLAN		Approval
10/06/2020	DIMETHYL FUMARATE ANDA #210226	ORIG-1	DIMETHYL FUMARATE	LUPIN ATLANTIS		Approval
10/06/2020	DIMETHYL FUMARATE ANDA #210309	ORIG-1	DIMETHYL FUMARATE	GLENMARK PHARMS LTD		Approval
10/06/2020	DIMETHYL FUMARATE ANDA #210436	ORIG-1	DIMETHYL FUMARATE	PHARMATHEN SA		Tentative Approval
10/06/2020	METHYLPHENIDATE HYDROCHLORIDE ANDA #212288	ORIG-1	METHYLPHENIDATE HYDROCHLORIDE	ALKEM LABS LTD		Approval
10/06/2020	ATROPINE SULFATE ANDA #212461	ORIG-1	ATROPINE SULFATE	INTL MEDICATION SYS		Approval
10/06/2020	FOSFOMYCIN TROMETHAMINE ANDA #212548	ORIG-1	FOSFOMYCIN TROMETHAMINE	XIROMED		Approval
10/06/2020	EPHEDRINE SULFATE ANDA #212649	ORIG-1	EPHEDRINE SULFATE	DR REDDYS LABS LTD		Approval
10/06/2020	ICATIBANT ACETATE ANDA #213054	ORIG-1	ICATIBANT ACETATE	DR REDDYS		Approval
10/06/2020	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ANDA #213335	ORIG-1	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	SPECGX LLC		Approval
10/06/2020	DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE NDA #213556	ORIG-1	DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD	Type 4 - New Combination	Tentative Approval
10/06/2020	HALOBETASOL PROPIONATE ANDA #213560	ORIG-1	HALOBETASOL PROPIONATE	QUAGEN		Approval
10/06/2020	PALYNZIQ BLA #761079	SUPPL-5	PEGVALIASE-PQPZ	BIOMARIN PHARM		Approval
10/06/2020	PALYNZIQ BLA #761079	SUPPL-6	PEGVALIASE-PQPZ	BIOMARIN PHARM		Approval
10/06/2020	PALYNZIQ BLA #761079	SUPPL-7	PEGVALIASE-PQPZ	BIOMARIN PHARM		Approval
10/07/2020	DIPENTUM NDA #019715	SUPPL-28	OLSALAZINE SODIUM	MYLAN SPECIALITY LP	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-19	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-22	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-25	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-26	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-30	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #076363	SUPPL-32	DIGOXIN	SUN PHARM INDS INC	Labeling	Approval
10/07/2020	DIGOXIN ANDA #077002	SUPPL-15	DIGOXIN	HIKMA INTL PHARMS	Labeling	Approval
10/07/2020	DIGOXIN ANDA #077002	SUPPL-20	DIGOXIN	HIKMA INTL PHARMS	Labeling	Approval
10/07/2020	DIGOXIN ANDA #077002	SUPPL-22	DIGOXIN	HIKMA INTL PHARMS	Labeling	Approval
10/07/2020	BUPROPION HYDROCHLORIDE ANDA #077285	SUPPL-35	BUPROPION HYDROCHLORIDE	WATSON LABS INC	Labeling	Approval
10/07/2020	LANSOPRAZOLE ANDA #202194	SUPPL-6	LANSOPRAZOLE	DR REDDYS LABS LTD	Labeling	Approval
10/07/2020	LANSOPRAZOLE ANDA #202194	SUPPL-7	LANSOPRAZOLE	DR REDDYS LABS LTD	Labeling	Approval
10/07/2020	LANSOPRAZOLE ANDA #202194	SUPPL-8	LANSOPRAZOLE	DR REDDYS LABS LTD	Labeling	Approval
10/07/2020	CINACALCET HYDROCHLORIDE ANDA #209403	ORIG-1	CINACALCET HYDROCHLORIDE	HETERO LABS LTD V		Approval
10/07/2020	AZELAIC ACID ANDA #210928	ORIG-1	AZELAIC ACID	TEVA PHARMS USA		Approval
10/07/2020	ACETAZOLAMIDE ANDA #214282	ORIG-1	ACETAZOLAMIDE	MANKIND PHARMA		Approval
10/08/2020	MONTELUKAST SODIUM ANDA #200405	SUPPL-10	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	MONTELUKAST SODIUM ANDA #200405	SUPPL-12	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	MONTELUKAST SODIUM ANDA #200405	SUPPL-14	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	MONTELUKAST SODIUM ANDA #201522	SUPPL-10	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	MONTELUKAST SODIUM ANDA #201522	SUPPL-12	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	MONTELUKAST SODIUM ANDA #201522	SUPPL-14	MONTELUKAST SODIUM	LANNETT CO INC	Labeling	Approval
10/08/2020	LANSOPRAZOLE ANDA #207157	SUPPL-1	LANSOPRAZOLE	LANNETT CO INC	Labeling	Approval
10/08/2020	LANSOPRAZOLE ANDA #207157	SUPPL-2	LANSOPRAZOLE	LANNETT CO INC	Labeling	Approval
10/08/2020	RUBRACA NDA #209115	SUPPL-8	RUCAPARIB CAMSYLATE	CLOVIS ONCOLOGY INC	Efficacy	Approval
10/08/2020	XENLETA NDA #211672	SUPPL-1	LEFAMULIN ACETATE	NABRIVA	Labeling	Approval
10/08/2020	XENLETA NDA #211673	SUPPL-1	LEFAMULIN ACETATE	NABRIVA	Labeling	Approval
10/08/2020	ALBUTEROL SULFATE ANDA #213524	ORIG-1	ALBUTEROL SULFATE	EYWA		Approval
10/08/2020	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ANDA #214238	ORIG-1	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	QUAGEN		Approval
10/09/2020	LAMICTAL NDA #020241	SUPPL-58	LAMOTRIGINE	GLAXOSMITHKLINE LLC	Labeling	Approval
10/09/2020	LAMICTAL CD NDA #020764	SUPPL-51	LAMOTRIGINE	GLAXOSMITHKLINE LLC	Labeling	Approval
10/09/2020	TINDAMAX NDA #021618	SUPPL-7	TINIDAZOLE	MISSION PHARMA	Labeling	Approval
10/09/2020	LAMICTAL XR NDA #022115	SUPPL-24	LAMOTRIGINE	GLAXOSMITHKLINE LLC	Labeling	Approval
10/09/2020	LAMICTAL ODT NDA #022251	SUPPL-22	LAMOTRIGINE	GLAXOSMITHKLINE LLC	Labeling	Approval
10/09/2020	UNASYN NDA #050608	SUPPL-47	AMPICILLIN SODIUM; SULBACTAM SODIUM	PFIZER	Labeling	Approval
10/09/2020	AVASTIN BLA #125085	SUPPL-336	BEVACIZUMAB	GENENTECH		Approval
10/09/2020	LEVONORGESTREL AND ETHINYL ESTRADIOL ANDA #207033	ORIG-1	ETHINYL ESTRADIOL; LEVONORGESTREL	ACCORD HLTHCARE		Approval
10/09/2020	BACLOFEN ANDA #212378	ORIG-1	BACLOFEN	INNOGENIX		Approval
10/09/2020	ULTOMIRIS BLA #761108	SUPPL-5	RAVULIZUMAB-CWVZ	ALEXION PHARM		Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-17	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-19	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-20	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-21	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-23	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	DIVALPROEX SODIUM ANDA #076941	SUPPL-25	DIVALPROEX SODIUM	TEVA	Labeling	Approval
10/13/2020	RISPERIDONE ANDA #077769	SUPPL-3	RISPERIDONE	HERITAGE PHARMA	Labeling	Approval
10/13/2020	RISPERIDONE ANDA #077769	SUPPL-4	RISPERIDONE	HERITAGE PHARMA	Labeling	Approval
10/13/2020	BINOSTO NDA #202344	SUPPL-15	ALENDRONATE SODIUM	ASCEND THERAPS US	Labeling	Approval
10/13/2020	REMIFENTANIL HYDROCHLORIDE ANDA #210594	ORIG-1	REMIFENTANIL HYDROCHLORIDE	NAVINTA LLC		Approval
10/13/2020	WAKIX NDA #211150	ORIG-2	PITOLISANT HYDROCHLORIDE	HARMONY	Efficacy	Approval
10/13/2020	TAVABOROLE ANDA #211297	ORIG-1	TAVABOROLE	ENCUBE		Approval
10/14/2020	PIPERACILLIN AND TAZOBACTAM ANDA #065523	SUPPL-7	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	ISTITUTO BIO ITA SPA	Labeling	Approval
10/14/2020	PIPERACILLIN AND TAZOBACTAM ANDA #065523	SUPPL-19	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	ISTITUTO BIO ITA SPA	Labeling	Approval
10/14/2020	PIPERACILLIN AND TAZOBACTAM ANDA #065523	SUPPL-21	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	ISTITUTO BIO ITA SPA	Labeling	Approval
10/14/2020	PIPERACILLIN AND TAZOBACTAM ANDA #065523	SUPPL-22	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	ISTITUTO BIO ITA SPA	Labeling	Approval
10/14/2020	VALPROIC ACID ANDA #077960	SUPPL-20	VALPROIC ACID	LANNETT CO INC	Labeling	Approval
10/14/2020	VALPROIC ACID ANDA #077960	SUPPL-21	VALPROIC ACID	LANNETT CO INC	Labeling	Approval
10/14/2020	VALPROIC ACID ANDA #077960	SUPPL-22	VALPROIC ACID	LANNETT CO INC	Labeling	Approval
10/14/2020	VALPROIC ACID ANDA #077960	SUPPL-24	VALPROIC ACID	LANNETT CO INC	Labeling	Approval
10/14/2020	VALPROIC ACID ANDA #077960	SUPPL-26	VALPROIC ACID	LANNETT CO INC	Labeling	Approval
10/14/2020	KEYTRUDA BLA #125514	SUPPL-85	PEMBROLIZUMAB	MERCK SHARP DOHME		Approval
10/14/2020	PRAMIPEXOLE DIHYDROCHLORIDE ANDA #203354	SUPPL-2	PRAMIPEXOLE DIHYDROCHLORIDE	DR REDDYS	Labeling	Approval
10/14/2020	PRAMIPEXOLE DIHYDROCHLORIDE ANDA #203354	SUPPL-5	PRAMIPEXOLE DIHYDROCHLORIDE	DR REDDYS	Labeling	Approval
10/14/2020	PRAMIPEXOLE DIHYDROCHLORIDE ANDA #203354	SUPPL-6	PRAMIPEXOLE DIHYDROCHLORIDE	DR REDDYS	Labeling	Approval
10/14/2020	DIMETHYL FUMARATE ANDA #210382	ORIG-1	DIMETHYL FUMARATE	TWI PHARMS		Approval
10/14/2020	INMAZEB BLA #761169	ORIG-1	ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB	REGENERON PHARMACEUTICALS		Approval
10/15/2020	CARDIOGEN-82 NDA #019414	SUPPL-21	RUBIDIUM CHLORIDE RB-82	BRACCO	Efficacy	Approval
10/15/2020	LUMIGAN NDA #021275	SUPPL-28	BIMATOPROST	ALLERGAN	Labeling	Approval
10/15/2020	PEGASYS BLA #103964	SUPPL-5273	PEGINTERFERON ALFA-2A	HOFFMAN-LA ROCHE		Approval
10/15/2020	VERAPAMIL HYDROCHLORIDE ANDA #214215	ORIG-1	VERAPAMIL HYDROCHLORIDE	ZYDUS PHARMS		Approval
10/15/2020	AMANTADINE HYDROCHLORIDE ANDA #214284	ORIG-1	AMANTADINE HYDROCHLORIDE	ALEMBIC PHARMS LTD		Approval
10/15/2020	VERAPAMIL HYDROCHLORIDE ANDA #214361	ORIG-1	VERAPAMIL HYDROCHLORIDE	GLAND PHARMA LTD		Approval
10/16/2020	ENSTILAR NDA #207589	SUPPL-10	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	LEO PHARMA AS	Efficacy	Approval
10/16/2020	VENCLEXTA NDA #208573	SUPPL-20	VENETOCLAX	ABBVIE INC	Efficacy	Approval
10/16/2020	VENCLEXTA NDA #208573	SUPPL-21	VENETOCLAX	ABBVIE INC	Efficacy	Approval
10/16/2020	EPHEDRINE SULFATE NDA #213994	ORIG-1	EPHEDRINE SULFATE	NEVAKAR INC	Type 5 - New Formulation or New Manufacturer	Approval

All Approvals and Tentative Approvals October 2020

All Approvals and Tentative Approvals
October 2020