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Drugs@FDA: FDA-Approved Drugs

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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 June 15, 2024.

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 ABBVIE 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 ABBVIE 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 SALIX 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 ENDO OPERATIONS Labeling Approval
10/01/2020 DELZICOL
NDA #204412
SUPPL-12 MESALAMINE ABBVIE 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 XIROMED 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 COSETTE 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 STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091576
SUPPL-20 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091588
SUPPL-17 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091588
SUPPL-19 MONTELUKAST SODIUM STRIDES PHARMA Labeling 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 COSETTE 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 HIKMA 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 GRAVITI PHARMS Labeling Approval
10/02/2020 GABAPENTIN
ANDA #207099
SUPPL-2 GABAPENTIN GRAVITI PHARMS Labeling Approval
10/02/2020 VIGABATRIN
ANDA #208218
SUPPL-11 VIGABATRIN ENDO OPERATIONS 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 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 REMS Approval
10/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #213897
ORIG-1 CLOMIPRAMINE HYDROCHLORIDE AJANTA PHARMA LTD Approval
10/03/2020 EPHEDRINE SULFATE
ANDA #212649
ORIG-1 EPHEDRINE SULFATE DR REDDYS Approval
10/05/2020 ERAXIS
NDA #021632
SUPPL-30 ANIDULAFUNGIN VICURON HOLDINGS 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
10/05/2020 DOXYCYCLINE HYCLATE
ANDA #209987
ORIG-1 DOXYCYCLINE HYCLATE RISING Approval
10/05/2020 ATROPINE SULFATE
ANDA #212461
ORIG-1 ATROPINE SULFATE INTL MEDICATION SYS Approval
10/05/2020 ICATIBANT ACETATE
ANDA #213054
ORIG-1 ICATIBANT ACETATE DR REDDYS 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 DIMETHYL FUMARATE
ANDA #210226
ORIG-1 DIMETHYL FUMARATE LUPIN Approval
10/06/2020 DIMETHYL FUMARATE
ANDA #210309
ORIG-1 DIMETHYL FUMARATE GLENMARK PHARMS LTD Approval
10/06/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #212288
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
10/06/2020 FOSFOMYCIN TROMETHAMINE
ANDA #212548
ORIG-1 FOSFOMYCIN TROMETHAMINE XIROMED 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 SPCLT VIATRIS 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 ACTIVASE
BLA #103172
SUPPL-5267 ALTEPLASE GENENTECH Approval
10/08/2020 CATHFLO ACTIVASE
BLA #103172
SUPPL-5267 ALTEPLASE GENENTECH 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 CHARTWELL MOLECULAR Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #201522
SUPPL-12 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #201522
SUPPL-14 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
10/08/2020 INJECTAFER
NDA #203565
SUPPL-12 FERRIC CARBOXYMALTOSE AM REGENT Manufacturing (CMC) Approval
10/08/2020 PROMACTA KIT
NDA #207027
SUPPL-13 ELTROMBOPAG OLAMINE NOVARTIS Manufacturing (CMC) 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 ZR PHARMA 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 FOLIC ACID
ANDA #202437
SUPPL-2 FOLIC ACID CADILA PHARMS LTD Labeling Approval
10/09/2020 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #207033
ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NAARI PTE LTD 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 FENOFIBRATE
ANDA #076635
SUPPL-10 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
10/13/2020 FENOFIBRATE
ANDA #076635
SUPPL-11 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
10/13/2020 FENOFIBRATE
ANDA #076635
SUPPL-13 FENOFIBRATE SUN PHARM INDS LTD Labeling 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 AVET Labeling Approval
10/13/2020 RISPERIDONE
ANDA #077769
SUPPL-4 RISPERIDONE HERITAGE PHARMA AVET Labeling Approval
10/13/2020 LEUCOVORIN CALCIUM
ANDA #089384
SUPPL-31 LEUCOVORIN CALCIUM HIKMA Labeling Approval
10/13/2020 DOXERCALCIFEROL
ANDA #091433
SUPPL-7 DOXERCALCIFEROL HIKMA Labeling Approval
10/13/2020 ATORVASTATIN CALCIUM
ANDA #091650
SUPPL-16 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
10/13/2020 ATORVASTATIN CALCIUM
ANDA #091650
SUPPL-17 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
10/13/2020 CYTARABINE
ANDA #200914
SUPPL-8 CYTARABINE RISING Labeling Approval
10/13/2020 CYTARABINE
ANDA #200915
SUPPL-5 CYTARABINE RISING Labeling Approval
10/13/2020 GLIMEPIRIDE
ANDA #202112
SUPPL-7 GLIMEPIRIDE INDOCO REMEDIES Labeling Approval
10/13/2020 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #202239
SUPPL-14 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
10/13/2020 BINOSTO
NDA #202344
SUPPL-15 ALENDRONATE SODIUM RADIUS Labeling Approval
10/13/2020 REMIFENTANIL HYDROCHLORIDE
ANDA #210594
ORIG-1 REMIFENTANIL HYDROCHLORIDE HIKMA 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
10/13/2020 TAVABOROLE
ANDA #211848
ORIG-1 TAVABOROLE PADAGIS US 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 FINGOLIMOD HYDROCHLORIDE
ANDA #207994
ORIG-1 FINGOLIMOD HYDROCHLORIDE ZYDUS PHARMS 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 ABBVIE Labeling Approval
10/15/2020 PEGASYS
BLA #103964
SUPPL-5273 PEGINTERFERON ALFA-2A zr pharma& Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963
SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963
SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963
SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202891
SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202891
SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/15/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210025
SUPPL-6 PHENYLEPHRINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/15/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #210231
SUPPL-4 SUCCINYLCHOLINE CHLORIDE AMRING PHARMS Labeling Approval
10/15/2020 VERAPAMIL HYDROCHLORIDE
ANDA #214215
ORIG-1 VERAPAMIL HYDROCHLORIDE ZYDUS PHARMS Approval
10/15/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #214246
SUPPL-1 SUCCINYLCHOLINE CHLORIDE GLAND PHARMA LTD Labeling Approval
10/15/2020 AMANTADINE HYDROCHLORIDE
ANDA #214284
ORIG-1 AMANTADINE HYDROCHLORIDE ALEMBIC Approval
10/15/2020 VERAPAMIL HYDROCHLORIDE
ANDA #214361
ORIG-1 VERAPAMIL HYDROCHLORIDE GLAND PHARMA LTD Approval
10/16/2020 BUPROPION HYDROCHLORIDE
ANDA #077715
SUPPL-34 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
10/16/2020 BUPROPION HYDROCHLORIDE
ANDA #077715
SUPPL-38 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
10/16/2020 RASAGILINE MESYLATE
ANDA #201970
SUPPL-5 RASAGILINE MESYLATE ORBION PHARMS Labeling Approval
10/16/2020 MIRTAZAPINE
ANDA #205798
SUPPL-1 MIRTAZAPINE SQUARE PHARMS Labeling Approval
10/16/2020 RASAGILINE MESYLATE
ANDA #207004
SUPPL-2 RASAGILINE MESYLATE MICRO LABS Labeling 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 Efficacy Approval
10/16/2020 VENCLEXTA
NDA #208573
SUPPL-21 VENETOCLAX ABBVIE Efficacy Approval
10/16/2020 SIROLIMUS
ANDA #208691
ORIG-1 SIROLIMUS GLENMARK PHARMS LTD Approval
10/16/2020 DOXEPIN HYDROCHLORIDE
ANDA #210675
ORIG-1 DOXEPIN HYDROCHLORIDE EPIC PHARMA LLC Approval
10/16/2020 EPHEDRINE SULFATE
NDA #213994
ORIG-1 EPHEDRINE SULFATE ENDO OPERATIONS Type 5 - New Formulation or New Manufacturer Approval
10/16/2020 URSODIOL
ANDA #214295
ORIG-1 URSODIOL ZYDUS LIFESCIENCES Approval
10/18/2020 AZITHROMYCIN
ANDA #209201
SUPPL-3 AZITHROMYCIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 QSYMIA
NDA #022580
SUPPL-17 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401
SUPPL-12 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401
SUPPL-14 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401
SUPPL-15 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 CISPLATIN
ANDA #074735
SUPPL-13 CISPLATIN FRESENIUS KABI USA Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080
SUPPL-1 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080
SUPPL-2 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080
SUPPL-3 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080
SUPPL-4 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080
SUPPL-5 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 NARATRIPTAN
ANDA #091326
SUPPL-4 NARATRIPTAN HYDROCHLORIDE PADAGIS US Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384
SUPPL-5 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384
SUPPL-6 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384
SUPPL-7 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384
SUPPL-8 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384
SUPPL-9 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 TRANEXAMIC ACID
ANDA #091657
SUPPL-9 TRANEXAMIC ACID MYLAN INSTITUTIONAL Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651
SUPPL-8 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651
SUPPL-9 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651
SUPPL-11 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651
SUPPL-12 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651
SUPPL-20 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 CYTARABINE
ANDA #200916
SUPPL-5 CYTARABINE MYLAN LABS LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043
SUPPL-21 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043
SUPPL-22 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043
SUPPL-28 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 TRANEXAMIC ACID
ANDA #201580
SUPPL-4 TRANEXAMIC ACID XGEN PHARMS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206
SUPPL-12 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206
SUPPL-13 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206
SUPPL-16 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206
SUPPL-18 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 ZOLEDRONIC ACID
ANDA #202650
SUPPL-10 ZOLEDRONIC ACID MYLAN LABS LTD Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208
SUPPL-3 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208
SUPPL-5 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208
SUPPL-7 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 JYNARQUE
NDA #204441
SUPPL-8 TOLVAPTAN OTSUKA Labeling Approval
10/19/2020 ZYDELIG
NDA #205858
SUPPL-14 IDELALISIB GILEAD SCIENCES INC Labeling Approval
10/19/2020 ARIKAYCE KIT
NDA #207356
SUPPL-3 AMIKACIN SULFATE INSMED INC Efficacy Approval
10/19/2020 SOLIFENACIN SUCCINATE
ANDA #207721
ORIG-1 SOLIFENACIN SUCCINATE ZYDUS PHARMS Approval
10/19/2020 LEVOTHYROXINE SODIUM
ANDA #212399
ORIG-1 LEVOTHYROXINE SODIUM ACCORD HLTHCARE Approval
10/19/2020 ETHACRYNIC ACID
ANDA #213240
ORIG-1 ETHACRYNIC ACID CHARTWELL RX Approval
10/19/2020 FENOFIBRATE (MICRONIZED)
ANDA #213842
ORIG-1 FENOFIBRATE ALEMBIC Approval
10/19/2020 IBUPROFEN
ANDA #214003
ORIG-1 IBUPROFEN YICHANG HUMANWELL Approval
10/20/2020 WELLBUTRIN
NDA #018644
SUPPL-57 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
10/20/2020 WELLBUTRIN SR
NDA #020358
SUPPL-64 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
10/20/2020 SABRIL
NDA #020427
SUPPL-23 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/20/2020 TRISENOX
NDA #021248
SUPPL-19 ARSENIC TRIOXIDE CEPHALON Labeling Approval
10/20/2020 FOLOTYN
NDA #022468
SUPPL-14 PRALATREXATE ACROTECH BIOPHARMA Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542
SUPPL-5 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542
SUPPL-6 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542
SUPPL-7 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542
SUPPL-8 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474
SUPPL-5 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474
SUPPL-6 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474
SUPPL-7 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474
SUPPL-8 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099
SUPPL-39 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099
SUPPL-41 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099
SUPPL-45 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509
SUPPL-8 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509
SUPPL-10 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509
SUPPL-11 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509
SUPPL-19 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182
SUPPL-2 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182
SUPPL-3 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182
SUPPL-4 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 NARATRIPTAN
ANDA #202431
SUPPL-3 NARATRIPTAN HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637
SUPPL-6 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637
SUPPL-8 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637
SUPPL-9 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637
SUPPL-15 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203328
SUPPL-10 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203432
SUPPL-10 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203438
SUPPL-16 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 NUZYRA
NDA #209816
SUPPL-9 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
10/20/2020 NUZYRA
NDA #209817
SUPPL-8 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
10/20/2020 KETOROLAC TROMETHAMINE
ANDA #212939
ORIG-1 KETOROLAC TROMETHAMINE EUGIA PHARMA Approval
10/20/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #213530
ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CHARTWELL RX Approval
10/20/2020 TRIAZOLAM
ANDA #214219
ORIG-1 TRIAZOLAM NOVAST LABS Approval
10/20/2020 ESOMEPRAZOLE MAGNESIUM
NDA #214278
ORIG-1 ESOMEPRAZOLE MAGNESIUM DEXCEL Type 3 - New Dosage Form Approval
10/21/2020 LEVOPHED
NDA #007513
SUPPL-45 NOREPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
10/21/2020 NORVIR
NDA #020659
SUPPL-72 RITONAVIR ABBVIE Labeling Approval
10/21/2020 NORVIR
NDA #020945
SUPPL-48 RITONAVIR ABBVIE Labeling Approval
10/21/2020 KALETRA
NDA #021226
SUPPL-49 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 KALETRA
NDA #021251
SUPPL-59 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 VALCYTE
NDA #021304
SUPPL-15 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
10/21/2020 KALETRA
NDA #021906
SUPPL-54 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 VALCYTE
NDA #022257
SUPPL-10 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Manufacturing (CMC) Approval
10/21/2020 VELETRI
NDA #022260
SUPPL-12 EPOPROSTENOL SODIUM ACTELION Labeling Approval
10/21/2020 OZURDEX
NDA #022315
SUPPL-13 DEXAMETHASONE ABBVIE Labeling Approval
10/21/2020 NORVIR
NDA #022417
SUPPL-24 RITONAVIR ABBVIE Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661
SUPPL-14 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661
SUPPL-16 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661
SUPPL-18 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661
SUPPL-19 GABAPENTIN RUBICON Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528
SUPPL-10 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528
SUPPL-11 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528
SUPPL-12 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528
SUPPL-13 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078740
SUPPL-6 RISPERIDONE WEST WARD PHARMS Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078740
SUPPL-7 RISPERIDONE WEST WARD PHARMS Labeling Approval
10/21/2020 LOSARTAN POTASSIUM
ANDA #090083
SUPPL-17 LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
10/21/2020 PALONOSETRON HYDROCHLORIDE
ANDA #202521
SUPPL-4 PALONOSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503
SUPPL-4 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503
SUPPL-5 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503
SUPPL-7 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #207128
ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE CHARTWELL RX Approval
10/21/2020 TIGECYCLINE
NDA #208744
SUPPL-3 TIGECYCLINE ACCORD HLTHCARE INC Labeling Approval
10/21/2020 SELENIOUS ACID
NDA #209379
SUPPL-3 SELENIOUS ACID AM REGENT Labeling Approval
10/21/2020 NORVIR
NDA #209512
SUPPL-7 RITONAVIR ABBVIE Labeling Approval
10/21/2020 DOXEPIN HYDROCHLORIDE
ANDA #210675
SUPPL-1 DOXEPIN HYDROCHLORIDE EPIC PHARMA LLC Approval
10/21/2020 ACETAMINOPHEN
ANDA #210969
ORIG-1 ACETAMINOPHEN EUGIA PHARMA Approval
10/21/2020 APREPITANT
ANDA #211835
ORIG-1 APREPITANT TORRENT Approval
10/21/2020 TAVABOROLE
ANDA #212188
ORIG-1 TAVABOROLE ALEMBIC Approval
10/21/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #213530
SUPPL-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CHARTWELL RX Approval
10/21/2020 METAXALONE
ANDA #213836
ORIG-1 METAXALONE INGENUS PHARMS LLC Approval
10/21/2020 IBUPROFEN
ANDA #214003
SUPPL-1 IBUPROFEN YICHANG HUMANWELL Approval
10/21/2020 VENLAFAXINE HYDROCHLORIDE
ANDA #214419
ORIG-1 VENLAFAXINE HYDROCHLORIDE ASCENT PHARMS INC Approval
10/21/2020 POTASSIUM CHLORIDE
ANDA #214452
ORIG-1 POTASSIUM CHLORIDE GRANULES Approval
10/22/2020 GANIRELIX ACETATE
NDA #021057
SUPPL-20 GANIRELIX ACETATE ORGANON USA ORGANON Labeling Approval
10/22/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076282
SUPPL-4 TIZANIDINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
10/22/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076286
SUPPL-15 TIZANIDINE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
10/22/2020 DOLISHALE
ANDA #091692
ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NOVAST LABS Approval
10/22/2020 CAMPATH
BLA #103948
SUPPL-5181 ALEMTUZUMAB GENZYME Approval
10/22/2020 LEMTRADA
BLA #103948
SUPPL-5181 ALEMTUZUMAB GENZYME Approval
10/22/2020 COMETRIQ
NDA #203756
SUPPL-9 CABOZANTINIB S-MALATE EXELIXIS Labeling Approval
10/22/2020 SILDENAFIL CITRATE
ANDA #203988
SUPPL-3 SILDENAFIL CITRATE EUGIA PHARMA Labeling Approval
10/22/2020 FEBUXOSTAT
ANDA #205374
ORIG-1 FEBUXOSTAT DR REDDYS Approval
10/22/2020 SIVEXTRO
NDA #205435
SUPPL-13 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
10/22/2020 SIVEXTRO
NDA #205436
SUPPL-8 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
10/22/2020 CHOLBAM
NDA #205750
SUPPL-3 CHOLIC ACID MIRUM Labeling Approval
10/22/2020 ALBUTEROL SULFATE
ANDA #208884
ORIG-1 ALBUTEROL SULFATE ZYDUS PHARMS Approval
10/22/2020 BACLOFEN
ANDA #209594
SUPPL-1 BACLOFEN MYLAN LABS LTD Labeling Approval
10/22/2020 BACLOFEN
ANDA #209594
SUPPL-2 BACLOFEN MYLAN LABS LTD Labeling Approval
10/22/2020 EPIDIOLEX
NDA #210365
SUPPL-8 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
10/22/2020 OLANZAPINE
ANDA #210968
ORIG-1 OLANZAPINE EUGIA PHARMA Approval
10/22/2020 TALZENNA
NDA #211651
SUPPL-6 TALAZOPARIB TOSYLATE PFIZER Efficacy Approval
10/22/2020 TIMOLOL MALEATE
ANDA #212942
ORIG-1 TIMOLOL MALEATE ALEMBIC Approval
10/22/2020 CARMUSTINE
ANDA #213207
ORIG-1 CARMUSTINE DR REDDYS Approval
10/22/2020 LEUCOVORIN CALCIUM
ANDA #213929
ORIG-1 LEUCOVORIN CALCIUM LEADING Approval
10/22/2020 VEKLURY
NDA #214787
ORIG-1 REMDESIVIR GILEAD SCIENCES INC Type 1 - New Molecular Entity Approval
10/23/2020 SYMBYAX
NDA #021520
SUPPL-51 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
10/23/2020 RAMIPRIL
ANDA #076549
SUPPL-18 RAMIPRIL WATSON LABS Labeling Approval
10/23/2020 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA #202509
SUPPL-11 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/23/2020 XTANDI
NDA #203415
SUPPL-16 ENZALUTAMIDE ASTELLAS Efficacy Approval
10/23/2020 FLUDEOXYGLUCOSE F18
ANDA #204498
SUPPL-2 FLUDEOXYGLUCOSE F-18 UNIV UTAH CYCLOTRON Labeling Approval
10/23/2020 TYMLOS
NDA #208743
SUPPL-7 ABALOPARATIDE RADIUS Labeling Approval
10/23/2020 VYLEESI (AUTOINJECTOR)
NDA #210557
SUPPL-2 BREMELANOTIDE ACETATE COSETTE Labeling Approval
10/23/2020 EZETIMIBE
ANDA #210673
ORIG-1 EZETIMIBE SCIEGEN PHARMS INC Approval
10/23/2020 DICLOFENAC SODIUM
ANDA #211253
SUPPL-7 DICLOFENAC SODIUM PERRIGO PHARMA INTL Manufacturing (CMC) Approval
10/23/2020 DICLOFENAC SODIUM
ANDA #211253
SUPPL-10 DICLOFENAC SODIUM PERRIGO PHARMA INTL Manufacturing (CMC) Approval
10/23/2020 TADALAFIL
ANDA #211298
ORIG-1 TADALAFIL UMEDICA Approval
10/23/2020 ZILEUTON
ANDA #211390
ORIG-1 ZILEUTON AIZANT Approval
10/23/2020 BUSULFAN
ANDA #212127
ORIG-1 BUSULFAN MEITHEAL Approval
10/23/2020 CLOFARABINE
ANDA #213461
ORIG-1 CLOFARABINE MEITHEAL Approval
10/26/2020 TROPHAMINE
NDA #019018
SUPPL-36 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
10/26/2020 TROPHAMINE 10%
NDA #019018
SUPPL-36 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
10/26/2020 SURVANTA
BLA #020032
SUPPL-46 BERACTANT ABBVIE Approval
10/26/2020 VALACYCLOVIR HYDROCHLORIDE
ANDA #077478
SUPPL-13 VALACYCLOVIR HYDROCHLORIDE SANDOZ Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894
SUPPL-7 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894
SUPPL-8 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894
SUPPL-9 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894
SUPPL-10 GABAPENTIN APOTEX Labeling Approval
10/26/2020 NARATRIPTAN
ANDA #200502
SUPPL-4 NARATRIPTAN HYDROCHLORIDE HERITAGE PHARMS Labeling Approval
10/26/2020 ADEFOVIR DIPIVOXIL
ANDA #202051
SUPPL-4 ADEFOVIR DIPIVOXIL SIGMAPHARM LABS LLC Labeling Approval
10/26/2020 DABIGATRAN ETEXILATE MESYLATE
ANDA #208048
ORIG-1 DABIGATRAN ETEXILATE MESYLATE DR REDDYS LABS LTD Tentative Approval
10/26/2020 XERMELO
NDA #208794
SUPPL-1 TELOTRISTAT ETIPRATE TERSERA Labeling Approval
10/26/2020 EYSUVIS
NDA #210933
ORIG-1 LOTEPREDNOL ETABONATE ALCON LABS INC Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
10/26/2020 RAMELTEON
ANDA #213815
ORIG-1 RAMELTEON UPSHER SMITH LABS Approval
10/26/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #214256
ORIG-1 CHLORPROMAZINE HYDROCHLORIDE SUN PHARM Approval
10/27/2020 ELESTRIN
NDA #021813
SUPPL-7 ESTRADIOL MYLAN SPECIALITY LP Labeling Approval
10/27/2020 ELESTRIN
NDA #021813
SUPPL-9 ESTRADIOL MYLAN SPECIALITY LP Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077242
SUPPL-27 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525
SUPPL-20 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525
SUPPL-24 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525
SUPPL-26 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525
SUPPL-34 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077662
SUPPL-23 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077662
SUPPL-26 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
10/27/2020 OXCARBAZEPINE
ANDA #078005
SUPPL-6 OXCARBAZEPINE ANI PHARMS Labeling Approval
10/27/2020 OXCARBAZEPINE
ANDA #078005
SUPPL-7 OXCARBAZEPINE ANI PHARMS Labeling Approval
10/27/2020 SKLICE
NDA #202736
SUPPL-6 IVERMECTIN ARBOR PHARMS LLC Efficacy Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231
SUPPL-15 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231
SUPPL-16 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231
SUPPL-17 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #207966
ORIG-1 MAGNESIUM SULFATE B BRAUN MEDICAL INC Approval
10/27/2020 TADALAFIL
ANDA #208824
ORIG-1 TADALAFIL HANGZHOU BINJIANG Approval
10/27/2020 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #209665
ORIG-1 CISATRACURIUM BESYLATE EUGIA PHARMA Approval
10/27/2020 BAQSIMI
NDA #210134
SUPPL-2 GLUCAGON AMPHASTAR PHARMS INC Labeling Approval
10/27/2020 AKYNZEO
NDA #210493
SUPPL-3 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Manufacturing (CMC) Approval
10/27/2020 PHENOXYBENZAMINE HYDROCHLORIDE
ANDA #212568
ORIG-1 PHENOXYBENZAMINE HYDROCHLORIDE AMNEAL Approval
10/27/2020 PALBOCICLIB
ANDA #213066
ORIG-1 PALBOCICLIB APOTEX INC Tentative Approval
10/27/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #213552
ORIG-1 SUCCINYLCHOLINE CHLORIDE NEXUS Approval
10/27/2020 AMPHETAMINE SULFATE
ANDA #213720
ORIG-1 AMPHETAMINE SULFATE ALKEM LABS LTD Approval
10/27/2020 AMPHETAMINE SULFATE
ANDA #213980
ORIG-1 AMPHETAMINE SULFATE EPIC PHARMA LLC Approval
10/27/2020 OXYBUTYNIN CHLORIDE
ANDA #214415
ORIG-1 OXYBUTYNIN CHLORIDE RUBICON Approval
10/28/2020 FOSCAVIR
NDA #020068
SUPPL-25 FOSCARNET SODIUM CLINIGEN HLTHCARE Manufacturing (CMC) Approval
10/28/2020 ALEVE
NDA #020204
SUPPL-76 NAPROXEN SODIUM BAYER Labeling Approval
10/28/2020 ANASTROZOLE
ANDA #078058
SUPPL-11 ANASTROZOLE TEVA PHARMS Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926
SUPPL-9 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926
SUPPL-10 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926
SUPPL-12 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926
SUPPL-15 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926
SUPPL-17 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 RISPERIDONE
ANDA #091537
SUPPL-9 RISPERIDONE DASH PHARMS Labeling Approval
10/28/2020 RISPERIDONE
ANDA #091537
SUPPL-10 RISPERIDONE DASH PHARMS Labeling Approval
10/28/2020 OXCARBAZEPINE
ANDA #201193
SUPPL-4 OXCARBAZEPINE HIKMA Labeling Approval
10/28/2020 OXCARBAZEPINE
ANDA #201193
SUPPL-5 OXCARBAZEPINE HIKMA Labeling Approval
10/28/2020 OFEV
NDA #205832
SUPPL-14 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Labeling Approval
10/28/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207991
ORIG-1 FINGOLIMOD HYDROCHLORIDE ACCORD HLTHCARE Approval
10/28/2020 ZINC SULFATE
NDA #209377
SUPPL-3 ZINC SULFATE AM REGENT Labeling Approval
10/28/2020 CAPECITABINE
ANDA #210604
SUPPL-1 CAPECITABINE EUGIA PHARMA Labeling Approval
10/28/2020 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #210906
SUPPL-4 CALCIUM GLUCONATE HQ SPCLT PHARMA Labeling Approval
10/28/2020 LEVOTHYROXINE SODIUM
ANDA #211369
ORIG-1 LEVOTHYROXINE SODIUM TEVA PHARMS USA INC Approval
10/28/2020 ACCRUFER
NDA #212320
SUPPL-5 FERRIC MALTOL SHIELD TX Labeling Approval
10/28/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #213936
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACCORD HLTHCARE Approval
10/29/2020 PENTASA
NDA #020049
SUPPL-34 MESALAMINE TAKEDA PHARMS USA Labeling Approval
10/29/2020 GEODON
NDA #020825
SUPPL-61 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
10/29/2020 GEODON
NDA #020919
SUPPL-49 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
10/29/2020 SILENOR
NDA #022036
SUPPL-6 DOXEPIN HYDROCHLORIDE CURRAX Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054
SUPPL-15 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054
SUPPL-16 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054
SUPPL-17 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 SOTALOL HYDROCHLORIDE
ANDA #075563
SUPPL-18 SOTALOL HYDROCHLORIDE OXFORD PHARMS Labeling Approval
10/29/2020 BACLOFEN
ANDA #077241
SUPPL-20 BACLOFEN LANNETT CO INC Labeling Approval
10/29/2020 TESTOSTERONE ENANTHATE
ANDA #091120
SUPPL-4 TESTOSTERONE ENANTHATE HIKMA FARMACEUTICA Labeling Approval
10/29/2020 FENOFIBRIC ACID
ANDA #201573
SUPPL-10 CHOLINE FENOFIBRATE ENDO OPERATIONS Labeling Approval
10/29/2020 TRANEXAMIC ACID
ANDA #202436
SUPPL-5 TRANEXAMIC ACID ACIC PHARMS Labeling Approval
10/29/2020 QUETIAPINE FUMARATE
ANDA #204253
SUPPL-11 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 QUETIAPINE FUMARATE
ANDA #204253
SUPPL-12 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 GUANFACINE HYDROCHLORIDE
ANDA #205430
SUPPL-2 GUANFACINE HYDROCHLORIDE APOTEX Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156
SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156
SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156
SUPPL-16 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 BUPROPION HYDROCHLORIDE
ANDA #207389
SUPPL-5 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
10/29/2020 TICAGRELOR
ANDA #208541
ORIG-1 TICAGRELOR DR REDDYS LABS INC Tentative Approval
10/29/2020 ENDARI
NDA #208587
SUPPL-3 L-GLUTAMINE EMMAUS MEDCL Labeling Approval
10/29/2020 TRULANCE
NDA #208745
SUPPL-10 PLECANATIDE SALIX Labeling Approval
10/29/2020 SODIUM NITROPRUSSIDE
ANDA #211277
ORIG-1 SODIUM NITROPRUSSIDE XIROMED Approval
10/29/2020 PALIPERIDONE
ANDA #212807
ORIG-1 PALIPERIDONE CSPC OUYI Approval
10/30/2020 SELZENTRY
NDA #022128
SUPPL-19 MARAVIROC VIIV HLTHCARE Efficacy Approval
10/30/2020 TESTOSTERONE ENANTHATE
ANDA #040575
SUPPL-10 TESTOSTERONE ENANTHATE NEXUS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178
SUPPL-24 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178
SUPPL-25 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178
SUPPL-26 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076281
SUPPL-7 TIZANIDINE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
10/30/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076371
SUPPL-3 TIZANIDINE HYDROCHLORIDE ANI PHARMS Labeling Approval
10/30/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #076684
SUPPL-11 ENOXAPARIN SODIUM AMPHASTAR PHARM Labeling Approval
10/30/2020 BRONCHITOL
NDA #202049
ORIG-1 MANNITOL CHIESI Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
10/30/2020 TRAZODONE HYDROCHLORIDE
ANDA #205253
SUPPL-8 TRAZODONE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/30/2020 MONTELUKAST SODIUM
ANDA #205319
ORIG-1 MONTELUKAST SODIUM BRECKENRIDGE Approval
10/30/2020 ALEVE PM
NDA #205352
SUPPL-15 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
10/30/2020 SOLIFENACIN SUCCINATE
ANDA #205575
SUPPL-4 SOLIFENACIN SUCCINATE ALEMBIC Labeling Approval
10/30/2020 PALIPERIDONE
ANDA #205618
SUPPL-2 PALIPERIDONE SUN PHARM Labeling Approval
10/30/2020 PALIPERIDONE
ANDA #205618
SUPPL-4 PALIPERIDONE SUN PHARM Labeling Approval
10/30/2020 SELZENTRY
NDA #208984
SUPPL-2 MARAVIROC VIIV HLTHCARE Efficacy Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635
SUPPL-8 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635
SUPPL-9 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635
SUPPL-10 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 POMALIDOMIDE
ANDA #210111
ORIG-1 POMALIDOMIDE BRECKENRIDGE Approval
10/30/2020 POMALIDOMIDE
ANDA #210249
ORIG-1 POMALIDOMIDE EUGIA PHARMA Approval
10/30/2020 NOREPINEPHRINE BITARTRATE
ANDA #210839
SUPPL-6 NOREPINEPHRINE BITARTRATE AMNEAL Labeling Approval
10/30/2020 TRIJARDY XR
NDA #212614
SUPPL-4 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
10/30/2020 LORATADINE
ANDA #213294
ORIG-1 LORATADINE TENSHI Approval
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