Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.

 

< Previous Month     Next Month >
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English