U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
July 2023

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 May 14, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/03/2023 NUCYNTA
NDA #022304		 SUPPL-24 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Efficacy Approval
07/03/2023 BENZTROPINE MESYLATE
ANDA #090233		 SUPPL-4 BENZTROPINE MESYLATE FRESENIUS KABI USA Labeling Approval
07/03/2023 NUCYNTA
NDA #203794		 SUPPL-10 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Efficacy Approval
07/03/2023 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205867		 SUPPL-11 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
07/03/2023 OSELTAMIVIR PHOSPHATE
ANDA #209113		 SUPPL-10 OSELTAMIVIR PHOSPHATE ZYDUS PHARMS Labeling Approval
07/03/2023 OSELTAMIVIR PHOSPHATE
ANDA #209113		 SUPPL-12 OSELTAMIVIR PHOSPHATE ZYDUS PHARMS Labeling Approval
07/03/2023 SUBLOCADE
NDA #209819		 SUPPL-24 BUPRENORPHINE INDIVIOR REMS Approval
07/03/2023 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #210321		 SUPPL-6 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
07/03/2023 METOPROLOL SUCCINATE
ANDA #211143		 SUPPL-4 METOPROLOL SUCCINATE ALKEM LABS LTD Labeling Approval
07/03/2023 OXCARBAZEPINE
ANDA #211747		 ORIG-1 OXCARBAZEPINE ZYDUS Approval
07/03/2023 KETOROLAC TROMETHAMINE
ANDA #212939		 SUPPL-1 KETOROLAC TROMETHAMINE EUGIA PHARMA Labeling Approval
07/03/2023 KETOROLAC TROMETHAMINE
ANDA #212939		 SUPPL-2 KETOROLAC TROMETHAMINE EUGIA PHARMA Labeling Approval
07/03/2023 DOLUTEGRAVIR
ANDA #216470		 ORIG-1 DOLUTEGRAVIR LUPIN LTD Tentative Approval
07/03/2023 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
ANDA #217511		 ORIG-1 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE RICONPHARMA LLC Approval
07/05/2023 LOPRESSOR
NDA #017963		 SUPPL-74 METOPROLOL TARTRATE VALIDUS PHARMS Labeling Approval
07/05/2023 VICTOZA
NDA #022341		 SUPPL-39 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
07/05/2023 INVOKANA
NDA #204042		 SUPPL-40 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
07/05/2023 INVOKAMET
NDA #204353		 SUPPL-42 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
07/05/2023 INVOKAMET XR
NDA #205879		 SUPPL-19 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
07/05/2023 DOCETAXEL
NDA #205934		 SUPPL-6 DOCETAXEL SHILPA Labeling Approval
07/05/2023 GLATOPA
ANDA #206921		 SUPPL-28 GLATIRAMER ACETATE SANDOZ Labeling Approval
07/05/2023 CABAZITAXEL
ANDA #207381		 ORIG-1 CABAZITAXEL MYLAN LABS LTD Approval
07/05/2023 FAMOTIDINE
ANDA #215630		 SUPPL-3 FAMOTIDINE ALKEM LABS LTD Manufacturing (CMC) Approval
07/05/2023 LOPERAMIDE HYDROCHLORIDE
ANDA #217840		 ORIG-1 LOPERAMIDE HYDROCHLORIDE JUBILANT CADISTA Approval
07/06/2023 PROMACTA
NDA #022291		 SUPPL-38 ELTROMBOPAG OLAMINE NOVARTIS Manufacturing (CMC) Approval
07/06/2023 NALTREXONE
ANDA #213195		 ORIG-1 NALTREXONE TEVA PHARMS USA INC Approval
07/06/2023 ADAPALENE
ANDA #215940		 SUPPL-1 ADAPALENE TARO Manufacturing (CMC) Approval
07/06/2023 FOMEPIZOLE
ANDA #216791		 ORIG-1 FOMEPIZOLE GLAND PHARMA LTD Approval
07/06/2023 LEQEMBI
BLA #761269		 SUPPL-1 LECANEMAB-IRMB EISAI INC Approval
07/07/2023 JEVTANA KIT
NDA #201023		 SUPPL-26 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
07/07/2023 TAPENTADOL
ANDA #205016		 ORIG-1 TAPENTADOL ALKEM LABS LTD Tentative Approval
07/07/2023 VILAZODONE HYDROCHLORIDE
ANDA #208228		 ORIG-1 VILAZODONE HYDROCHLORIDE APOTEX Approval
07/07/2023 LEQVIO
NDA #214012		 SUPPL-9 INCLISIRAN SODIUM NOVARTIS Labeling Approval
07/07/2023 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #214890		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE GENEYORK PHARMS Approval
07/07/2023 NICARDIPINE HYDROCHLORIDE
ANDA #216420		 ORIG-1 NICARDIPINE HYDROCHLORIDE MICRO LABS Approval
07/07/2023 FAMOTIDINE
ANDA #217137		 ORIG-1 FAMOTIDINE CARNEGIE Approval
07/10/2023 CLARITHROMYCIN
ANDA #065155		 SUPPL-13 CLARITHROMYCIN TEVA Labeling Approval
07/10/2023 CLARITHROMYCIN
ANDA #065155		 SUPPL-14 CLARITHROMYCIN TEVA Labeling Approval
07/10/2023 CLARITHROMYCIN
ANDA #065155		 SUPPL-15 CLARITHROMYCIN TEVA Labeling Approval
07/10/2023 CLARITHROMYCIN
ANDA #065155		 SUPPL-17 CLARITHROMYCIN TEVA Labeling Approval
07/10/2023 CLARITHROMYCIN
ANDA #065155		 SUPPL-20 CLARITHROMYCIN TEVA Labeling Approval
07/10/2023 CAPECITABINE
ANDA #091649		 SUPPL-15 CAPECITABINE TEVA PHARMS USA Labeling Approval
07/10/2023 KETOROLAC TROMETHAMINE
ANDA #201155		 SUPPL-3 KETOROLAC TROMETHAMINE STERISCIENCE Labeling Approval
07/10/2023 KETOROLAC TROMETHAMINE
ANDA #201155		 SUPPL-4 KETOROLAC TROMETHAMINE STERISCIENCE Labeling Approval
07/10/2023 KETOROLAC TROMETHAMINE
ANDA #204216		 SUPPL-11 KETOROLAC TROMETHAMINE GLAND Labeling Approval
07/10/2023 KETOROLAC TROMETHAMINE
ANDA #204216		 SUPPL-13 KETOROLAC TROMETHAMINE GLAND Labeling Approval
07/10/2023 TOBRAMYCIN
ANDA #205501		 SUPPL-13 TOBRAMYCIN AMNEAL PHARMS Labeling Approval
07/10/2023 TOBRAMYCIN
ANDA #207080		 SUPPL-12 TOBRAMYCIN DR REDDYS LABS SA Labeling Approval
07/10/2023 XULTOPHY 100/3.6
BLA #208583		 SUPPL-21 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
07/10/2023 DIVALPROEX SODIUM
ANDA #209286		 SUPPL-8 DIVALPROEX SODIUM LUPIN LTD Labeling Approval
07/10/2023 CLONIDINE HYDROCHLORIDE
ANDA #209757		 SUPPL-2 CLONIDINE HYDROCHLORIDE XIAMEN LP PHARM CO Labeling Approval
07/10/2023 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-23 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
07/10/2023 BUPROPION HYDROCHLORIDE
ANDA #211347		 SUPPL-10 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Labeling Approval
07/10/2023 ATORVASTATIN CALCIUM
ANDA #211933		 SUPPL-17 ATORVASTATIN CALCIUM MSN Labeling Approval
07/10/2023 RAMELTEON
ANDA #215972		 ORIG-1 RAMELTEON AUROBINDO PHARMA LTD Approval
07/10/2023 ACETAMINOPHEN AND IBUPROFEN
ANDA #216994		 ORIG-1 ACETAMINOPHEN; IBUPROFEN MARKSANS PHARMA Approval
07/10/2023 LEUCOVORIN CALCIUM
ANDA #217021		 ORIG-1 LEUCOVORIN CALCIUM HAINAN POLY Approval
07/11/2023 ALEVE-D SINUS & COLD
NDA #021076		 SUPPL-19 NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE BAYER Labeling Approval
07/11/2023 ATORVASTATIN CALCIUM
ANDA #091226		 SUPPL-30 ATORVASTATIN CALCIUM MYLAN PHARMS INC Labeling Approval
07/11/2023 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-27 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
07/11/2023 OLMESARTAN MEDOXOMIL
ANDA #207480		 ORIG-1 OLMESARTAN MEDOXOMIL AMNEAL Approval
07/11/2023 SEVELAMER HYDROCHLORIDE
ANDA #212599		 ORIG-1 SEVELAMER HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
07/11/2023 BROMFENAC
ANDA #212964		 ORIG-1 BROMFENAC EUGIA PHARMA SPECLTS Tentative Approval
07/11/2023 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #217357		 ORIG-1 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE MANKIND PHARMA Approval
07/11/2023 STERILE WATER FOR INJECTION
ANDA #217536		 ORIG-1 STERILE WATER FOR INJECTION NEXUS Approval
07/11/2023 LIDOCAINE HYDROCHLORIDE
ANDA #217693		 ORIG-1 LIDOCAINE HYDROCHLORIDE MANKIND PHARMA Approval
07/11/2023 SODIUM CHLORIDE 23.4%
ANDA #217796		 ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
07/11/2023 HADLIMA
BLA #761059		 SUPPL-8 ADALIMUMAB-BWWD SAMSUNG BIOEPIS CO LTD Approval
07/12/2023 JEANATOPE
BLA #017836		 SUPPL-9 ALBUMIN IODINATED I-125 SERUM ISO TEX Approval
07/12/2023 DIFLUCAN
NDA #019949		 SUPPL-74 FLUCONAZOLE PFIZER Labeling Approval
07/12/2023 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-73 FLUCONAZOLE PFIZER Labeling Approval
07/12/2023 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-73 FLUCONAZOLE PFIZER Labeling Approval
07/12/2023 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-73 FLUCONAZOLE PFIZER Labeling Approval
07/12/2023 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-48 HEPARIN SODIUM B BRAUN Labeling Approval
07/12/2023 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-48 HEPARIN SODIUM B BRAUN Labeling Approval
07/12/2023 DIFLUCAN
NDA #020090		 SUPPL-55 FLUCONAZOLE PFIZER Labeling Approval
07/12/2023 XIAFLEX
BLA #125338		 SUPPL-111 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
07/12/2023 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202544		 SUPPL-7 HYDROCHLOROTHIAZIDE; TELMISARTAN GLENMARK PHARMS LTD Labeling Approval
07/12/2023 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206083		 SUPPL-5 HYDROCHLOROTHIAZIDE; VALSARTAN PRINSTON INC Labeling Approval
07/12/2023 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206083		 SUPPL-6 HYDROCHLOROTHIAZIDE; VALSARTAN PRINSTON INC Labeling Approval
07/12/2023 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206083		 SUPPL-7 HYDROCHLOROTHIAZIDE; VALSARTAN PRINSTON INC Labeling Approval
07/12/2023 PREGABALIN
ANDA #206452		 ORIG-1 PREGABALIN CADILA PHARMS LTD Approval
07/12/2023 DOXYCYCLINE HYCLATE
ANDA #208818		 SUPPL-5 DOXYCYCLINE HYCLATE LUPIN LTD Labeling Approval
07/12/2023 DOXYCYCLINE HYCLATE
ANDA #208818		 SUPPL-6 DOXYCYCLINE HYCLATE LUPIN LTD Labeling Approval
07/12/2023 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208861		 SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
07/12/2023 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208861		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
07/12/2023 NALOXONE HYDROCHLORIDE
ANDA #208871		 SUPPL-1 NALOXONE HYDROCHLORIDE RISING Labeling Approval
07/12/2023 NALOXONE HYDROCHLORIDE
ANDA #208871		 SUPPL-4 NALOXONE HYDROCHLORIDE RISING Labeling Approval
07/12/2023 NALOXONE HYDROCHLORIDE
ANDA #208872		 SUPPL-3 NALOXONE HYDROCHLORIDE RISING Labeling Approval
07/12/2023 DOXORUBICIN HYDROCHLORIDE
ANDA #208888		 SUPPL-2 DOXORUBICIN HYDROCHLORIDE AMNEAL Labeling Approval
07/12/2023 DOXORUBICIN HYDROCHLORIDE
ANDA #208888		 SUPPL-3 DOXORUBICIN HYDROCHLORIDE AMNEAL Labeling Approval
07/12/2023 LACOSAMIDE
ANDA #209301		 SUPPL-1 LACOSAMIDE HETERO LABS LTD III Labeling Approval
07/12/2023 LEVOLEUCOVORIN CALCIUM
ANDA #210892		 SUPPL-1 LEVOLEUCOVORIN CALCIUM GLAND PHARMA LTD Labeling Approval
07/12/2023 LEVOLEUCOVORIN CALCIUM
ANDA #210892		 SUPPL-3 LEVOLEUCOVORIN CALCIUM GLAND PHARMA LTD Labeling Approval
07/12/2023 HYDROXYCHLOROQUINE SULFATE
ANDA #210959		 SUPPL-10 HYDROXYCHLOROQUINE SULFATE LAURUS Labeling Approval
07/12/2023 HYDROXYCHLOROQUINE SULFATE
ANDA #210959		 SUPPL-12 HYDROXYCHLOROQUINE SULFATE LAURUS Labeling Approval
07/12/2023 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #211868		 ORIG-1 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE EMCURE PHARMS LTD Type 4 - New Combination Tentative Approval
07/12/2023 POTASSIUM CHLORIDE
ANDA #212816		 ORIG-1 POTASSIUM CHLORIDE NOVITIUM PHARMA Approval
07/12/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #214473		 ORIG-1 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Approval
07/12/2023 PEMETREXED DISODIUM
ANDA #214632		 SUPPL-1 PEMETREXED DISODIUM EUGIA PHARMA Labeling Approval
07/12/2023 DOCETAXEL
ANDA #215744		 SUPPL-2 DOCETAXEL ALEMBIC Labeling Approval
07/12/2023 GUAIFENESIN
ANDA #215932		 SUPPL-3 GUAIFENESIN DR REDDYS Labeling Approval
07/12/2023 METRONIDAZOLE
ANDA #216323		 ORIG-1 METRONIDAZOLE COSETTE Approval
07/12/2023 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #216597		 SUPPL-1 MAGNESIUM SULFATE AMNEAL Labeling Approval
07/12/2023 AMJEVITA
BLA #761024		 SUPPL-17 ADALIMUMAB-ATTO AMGEN INC Approval
07/13/2023 OPILL
NDA #017031		 SUPPL-41 NORGESTREL LABORATOIRE HRA Efficacy Approval
07/13/2023 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #070627		 SUPPL-9 SULFAMETHOXAZOLE; TRIMETHOPRIM HIKMA Labeling Approval
07/13/2023 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #070627		 SUPPL-10 SULFAMETHOXAZOLE; TRIMETHOPRIM HIKMA Labeling Approval
07/13/2023 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #070628		 SUPPL-12 SULFAMETHOXAZOLE; TRIMETHOPRIM HIKMA Labeling Approval
07/13/2023 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #070628		 SUPPL-13 SULFAMETHOXAZOLE; TRIMETHOPRIM HIKMA Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079169		 SUPPL-9 ROSUVASTATIN CALCIUM SUN PHARM Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079169		 SUPPL-12 ROSUVASTATIN CALCIUM SUN PHARM Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079169		 SUPPL-13 ROSUVASTATIN CALCIUM SUN PHARM Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079169		 SUPPL-15 ROSUVASTATIN CALCIUM SUN PHARM Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079171		 SUPPL-6 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079171		 SUPPL-7 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079171		 SUPPL-13 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-7 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-10 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-14 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-15 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-4 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-5 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-9 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-10 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
07/13/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #205587		 SUPPL-3 ROSUVASTATIN CALCIUM LUPIN Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #206381		 SUPPL-2 ROSUVASTATIN CALCIUM SCIEGEN PHARMS INC Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #206381		 SUPPL-3 ROSUVASTATIN CALCIUM SCIEGEN PHARMS INC Labeling Approval
07/13/2023 ROSUVASTATIN CALCIUM
ANDA #206381		 SUPPL-6 ROSUVASTATIN CALCIUM SCIEGEN PHARMS INC Labeling Approval
07/13/2023 ENZALUTAMIDE
ANDA #211465		 ORIG-1 ENZALUTAMIDE EUGIA PHARMA Tentative Approval
07/13/2023 CHLORPROMAZINE HYDROCHLORIDE
ANDA #213327		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE LUPIN Approval
07/13/2023 OXCARBAZEPINE
ANDA #213369		 ORIG-1 OXCARBAZEPINE APOTEX Approval
07/13/2023 VEKLURY
NDA #214787		 SUPPL-19 REMDESIVIR GILEAD SCIENCES INC Efficacy Approval
07/13/2023 ACETAMINOPHEN AND IBUPROFEN
ANDA #216592		 ORIG-1 ACETAMINOPHEN; IBUPROFEN GRANULES Approval
07/13/2023 ERTUGLIFLOZIN
ANDA #216947		 ORIG-1 ERTUGLIFLOZIN AUROBINDO PHARMA LTD Approval
07/14/2023 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076766		 SUPPL-14 FLUCONAZOLE BAXTER HLTHCARE Labeling Approval
07/14/2023 TELMISARTAN
ANDA #202397		 SUPPL-10 TELMISARTAN MYLAN Labeling Approval
07/14/2023 TELMISARTAN
ANDA #202397		 SUPPL-11 TELMISARTAN MYLAN Labeling Approval
07/14/2023 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-8 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
07/14/2023 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-9 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
07/14/2023 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-14 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
07/14/2023 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-15 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
07/14/2023 AUROVELA 24 FE
ANDA #207504		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Labeling Approval
07/14/2023 AUROVELA 24 FE
ANDA #207504		 SUPPL-12 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Labeling Approval
07/14/2023 HAILEY FE 1.5/30
ANDA #209031		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS Labeling Approval
07/14/2023 HAILEY FE 1.5/30
ANDA #209031		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE GLENMARK PHARMS Labeling Approval
07/14/2023 KETOROLAC TROMETHAMINE
ANDA #209900		 SUPPL-4 KETOROLAC TROMETHAMINE BAXTER HLTHCARE CORP Labeling Approval
07/14/2023 KETOROLAC TROMETHAMINE
ANDA #209900		 SUPPL-6 KETOROLAC TROMETHAMINE BAXTER HLTHCARE CORP Labeling Approval
07/14/2023 APREMILAST
ANDA #211756		 ORIG-1 APREMILAST DR REDDYS Approval
07/14/2023 KETOROLAC TROMETHAMINE
ANDA #214456		 SUPPL-1 KETOROLAC TROMETHAMINE ALEMBIC Labeling Approval
07/14/2023 KETOROLAC TROMETHAMINE
ANDA #214456		 SUPPL-3 KETOROLAC TROMETHAMINE ALEMBIC Labeling Approval
07/14/2023 PONATINIB HYDROCHLORIDE
ANDA #215893		 ORIG-1 PONATINIB HYDROCHLORIDE APOTEX Approval
07/14/2023 ACALABRUTINIB
ANDA #216405		 ORIG-1 ACALABRUTINIB SANDOZ INC Tentative Approval
07/14/2023 BISOPROLOL FUMARATE
ANDA #217368		 ORIG-1 BISOPROLOL FUMARATE PRINSTON INC Approval
07/14/2023 SODIUM PHENYLACETATE AND SODIUM BENZOATE
ANDA #217526		 ORIG-1 SODIUM BENZOATE; SODIUM PHENYLACETATE NAVINTA LLC Approval
07/14/2023 DUPIXENT
BLA #761055		 SUPPL-50 DUPILUMAB REGENERON PHARMACEUTICALS Approval
07/17/2023 SODIUM PHOSPHATES IN PLASTIC CONTAINER
NDA #018892		 SUPPL-37 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS HOSPIRA Manufacturing (CMC) Approval
07/17/2023 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076303		 SUPPL-25 FLUCONAZOLE HOSPIRA Labeling Approval
07/17/2023 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076303		 SUPPL-26 FLUCONAZOLE HOSPIRA Labeling Approval
07/17/2023 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #076304		 SUPPL-24 FLUCONAZOLE HOSPIRA Labeling Approval
07/17/2023 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #076304		 SUPPL-25 FLUCONAZOLE HOSPIRA Labeling Approval
07/17/2023 MEPERIDINE HYDROCHLORIDE
ANDA #088640		 SUPPL-41 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
07/17/2023 MEPERIDINE HYDROCHLORIDE
ANDA #088640		 SUPPL-43 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
07/17/2023 MEPERIDINE HYDROCHLORIDE
ANDA #088640		 SUPPL-47 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
07/17/2023 LARIN FE 1.5/30
ANDA #091453		 SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
07/17/2023 LARIN FE 1.5/30
ANDA #091453		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
07/17/2023 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091519		 SUPPL-4 HYDROCHLOROTHIAZIDE; VALSARTAN WATSON LABS TEVA Labeling Approval
07/17/2023 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091519		 SUPPL-5 HYDROCHLOROTHIAZIDE; VALSARTAN WATSON LABS TEVA Labeling Approval
07/17/2023 ARIPIPRAZOLE
ANDA #207105		 SUPPL-2 ARIPIPRAZOLE ALKEM LABS LTD Labeling Approval
07/17/2023 ARIPIPRAZOLE
ANDA #207105		 SUPPL-3 ARIPIPRAZOLE ALKEM LABS LTD Labeling Approval
07/17/2023 ARIPIPRAZOLE
ANDA #207105		 SUPPL-8 ARIPIPRAZOLE ALKEM LABS LTD Labeling Approval
07/17/2023 BETAMETHASONE DIPROPIONATE
ANDA #214048		 SUPPL-5 BETAMETHASONE DIPROPIONATE ZYDUS LIFESCIENCES Labeling Approval
07/17/2023 CYCLOPHOSPHAMIDE
ANDA #214529		 ORIG-1 CYCLOPHOSPHAMIDE SAGENT PHARMS INC Approval
07/17/2023 HYDROCORTISONE
ANDA #214649		 ORIG-1 HYDROCORTISONE AUROBINDO PHARMA LTD Approval
07/17/2023 NICARDIPINE HYDROCHLORIDE
ANDA #215377		 ORIG-1 NICARDIPINE HYDROCHLORIDE SENORES PHARMS Approval
07/17/2023 TOPIRAMATE
ANDA #215414		 SUPPL-1 TOPIRAMATE ASCENT PHARMS INC Labeling Approval
07/17/2023 TOPIRAMATE
ANDA #215414		 SUPPL-2 TOPIRAMATE ASCENT PHARMS INC Labeling Approval
07/17/2023 ENCORAFENIB
ANDA #217404		 ORIG-1 ENCORAFENIB SANDOZ INC Tentative Approval
07/17/2023 GABAPENTIN
ANDA #217546		 SUPPL-1 GABAPENTIN LAURUS Labeling Approval
07/17/2023 TEPEZZA
BLA #761143		 SUPPL-23 TEPROTUMUMAB-TRBW HORIZON THERAPEUTICS IRELAND Approval
07/17/2023 BEYFORTUS
BLA #761328		 ORIG-1 NIRSEVIMAB-ALIP ASTRAZENECA AB Approval
07/18/2023 ACIPHEX
NDA #020973		 SUPPL-43 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
07/18/2023 PROTONIX
NDA #020987		 SUPPL-60 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/18/2023 PROTONIX IV
NDA #020988		 SUPPL-69 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/18/2023 ZYVOX
NDA #021130		 SUPPL-44 LINEZOLID PFIZER Labeling Approval
07/18/2023 ZYVOX
NDA #021131		 SUPPL-41 LINEZOLID PFIZER Labeling Approval
07/18/2023 ZYVOX
NDA #021132		 SUPPL-43 LINEZOLID PFIZER Labeling Approval
07/18/2023 NEXIUM
NDA #021153		 SUPPL-60 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
07/18/2023 ZEGERID
NDA #021636		 SUPPL-25 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
07/18/2023 NEXIUM IV
NDA #021689		 SUPPL-38 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
07/18/2023 ZEGERID
NDA #021849		 SUPPL-20 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
07/18/2023 ABSORICA
NDA #021951		 SUPPL-23 ISOTRETINOIN SUN PHARM INDS INC Labeling Approval
07/18/2023 ABSORICA
NDA #021951		 SUPPL-24 ISOTRETINOIN SUN PHARM INDS INC Labeling Approval
07/18/2023 NEXIUM
NDA #021957		 SUPPL-27 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
07/18/2023 PROTONIX
NDA #022020		 SUPPL-23 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/18/2023 PRILOSEC
NDA #022056		 SUPPL-26 OMEPRAZOLE MAGNESIUM COVIS Labeling Approval
07/18/2023 NEXIUM
NDA #022101		 SUPPL-24 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
07/18/2023 DEXILANT
NDA #022287		 SUPPL-38 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
07/18/2023 VIMOVO
NDA #022511		 SUPPL-29 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #075347		 SUPPL-30 OMEPRAZOLE ACTAVIS LABS FL INC Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #075410		 SUPPL-68 OMEPRAZOLE LANNETT CO INC Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #075576		 SUPPL-25 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #075785		 SUPPL-14 OMEPRAZOLE IMPAX LABS Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #075876		 SUPPL-45 OMEPRAZOLE STRIDES PHARMA Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #076048		 SUPPL-29 OMEPRAZOLE APOTEX Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #078490		 SUPPL-22 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #091352		 SUPPL-23 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #091672		 SUPPL-24 OMEPRAZOLE GLENMARK PHARMS LTD Labeling Approval
07/18/2023 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-10 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
07/18/2023 VARENICLINE TARTRATE
ANDA #201962		 SUPPL-3 VARENICLINE TARTRATE APOTEX Manufacturing (CMC) Approval
07/18/2023 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #202588		 SUPPL-10 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE SANDOZ Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #203270		 SUPPL-20 OMEPRAZOLE AUROBINDO PHARMA Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #203481		 SUPPL-8 OMEPRAZOLE BRECKENRIDGE Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #204012		 SUPPL-3 OMEPRAZOLE HETERO LABS LTD III Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #204661		 SUPPL-8 OMEPRAZOLE TEVA PHARMS USA Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #205070		 SUPPL-4 OMEPRAZOLE MYLAN Labeling Approval
07/18/2023 YOSPRALA
NDA #205103		 SUPPL-9 ASPIRIN; OMEPRAZOLE GENUS LIFESCIENCES Labeling Approval
07/18/2023 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006		 SUPPL-6 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE RISING Labeling Approval
07/18/2023 VILAZODONE HYDROCHLORIDE
ANDA #208202		 SUPPL-1 VILAZODONE HYDROCHLORIDE ALEMBIC Labeling Approval
07/18/2023 VILAZODONE HYDROCHLORIDE
ANDA #208202		 SUPPL-2 VILAZODONE HYDROCHLORIDE ALEMBIC Manufacturing (CMC) Approval
07/18/2023 VILAZODONE HYDROCHLORIDE
ANDA #208202		 SUPPL-4 VILAZODONE HYDROCHLORIDE ALEMBIC Labeling Approval
07/18/2023 PANTOPRAZOLE SODIUM
NDA #209463		 SUPPL-21 PANTOPRAZOLE SODIUM HIKMA Labeling Approval
07/18/2023 GOPRELTO
NDA #209963		 SUPPL-5 COCAINE HYDROCHLORIDE NODEN PHARMA Labeling Approval
07/18/2023 ABSORICA LD
NDA #211913		 SUPPL-11 ISOTRETINOIN SUN PHARM Labeling Approval
07/18/2023 NALOXONE HYDROCHLORIDE
ANDA #211951		 SUPPL-3 NALOXONE HYDROCHLORIDE PADAGIS ISRAEL Labeling Approval
07/18/2023 OMEPRAZOLE
ANDA #212977		 SUPPL-8 OMEPRAZOLE XIROMED Labeling Approval
07/18/2023 TALICIA
NDA #213004		 SUPPL-12 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN REDHILL Labeling Approval
07/18/2023 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
NDA #215187		 ORIG-1 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE LUPIN PHARMS Type 4 - New Combination Tentative Approval
07/18/2023 CHLORPROMAZINE HYDROCHLORIDE
ANDA #217350		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE ALEMBIC Approval
07/19/2023 ACTIGALL
NDA #019594		 SUPPL-37 URSODIOL TEVA BRANDED PHARM Labeling Approval
07/19/2023 APREMILAST
ANDA #211716		 ORIG-1 APREMILAST AUROBINDO PHARMA LTD Approval
07/19/2023 FENOFIBRIC ACID
ANDA #213450		 SUPPL-1 CHOLINE FENOFIBRATE MICRO LABS Labeling Approval
07/19/2023 LEUCOVORIN CALCIUM
ANDA #216590		 ORIG-1 LEUCOVORIN CALCIUM KINDOS Approval
07/19/2023 GABAPENTIN
ANDA #217995		 ORIG-1 GABAPENTIN RISING Approval
07/19/2023 SILIQ
BLA #761032		 SUPPL-11 BRODALUMAB VALEANT LUXEMBOURG Approval
07/19/2023 CYLTEZO
BLA #761058		 SUPPL-25 ADALIMUMAB-ADBM BOEHRINGER INGELHEIM Approval
07/20/2023 ELIGARD KIT
NDA #021343		 SUPPL-47 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021343		 SUPPL-48 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021379		 SUPPL-49 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021379		 SUPPL-50 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ZETIA
NDA #021445		 SUPPL-42 EZETIMIBE ORGANON Labeling Approval
07/20/2023 ELIGARD KIT
NDA #021488		 SUPPL-44 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021488		 SUPPL-45 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021731		 SUPPL-44 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 ELIGARD KIT
NDA #021731		 SUPPL-47 LEUPROLIDE ACETATE TOLMAR Efficacy Approval
07/20/2023 LEVOTHYROXINE SODIUM
ANDA #076187		 SUPPL-50 LEVOTHYROXINE SODIUM MYLAN Labeling Approval
07/20/2023 FLUCONAZOLE
ANDA #077253		 SUPPL-23 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
07/20/2023 FLUCONAZOLE
ANDA #077253		 SUPPL-24 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
07/20/2023 GRANISETRON HYDROCHLORIDE
ANDA #078846		 SUPPL-3 GRANISETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
07/20/2023 GRANISETRON HYDROCHLORIDE
ANDA #078846		 SUPPL-4 GRANISETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
07/20/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617		 SUPPL-35 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
07/20/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 SUPPL-10 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
07/20/2023 TRANEXAMIC ACID
ANDA #201885		 SUPPL-10 TRANEXAMIC ACID AM REGENT Labeling Approval
07/20/2023 FLUVASTATIN SODIUM
ANDA #202458		 SUPPL-2 FLUVASTATIN SODIUM MYLAN Labeling Approval
07/20/2023 FLUVASTATIN SODIUM
ANDA #202458		 SUPPL-5 FLUVASTATIN SODIUM MYLAN Labeling Approval
07/20/2023 SPIRONOLACTONE
ANDA #203253		 SUPPL-18 SPIRONOLACTONE JUBILANT GENERICS Labeling Approval
07/20/2023 TELMISARTAN
ANDA #204415		 SUPPL-15 TELMISARTAN AMNEAL PHARMS Labeling Approval
07/20/2023 OTEZLA
NDA #205437		 SUPPL-12 APREMILAST AMGEN INC Efficacy Approval
07/20/2023 AMANTADINE HYDROCHLORIDE
ANDA #208278		 SUPPL-3 AMANTADINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
07/20/2023 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209211		 SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE CEDIPROF INC Labeling Approval
07/20/2023 AZITHROMYCIN
ANDA #210001		 SUPPL-7 AZITHROMYCIN BIONPHARMA Labeling Approval
07/20/2023 AZITHROMYCIN
ANDA #210001		 SUPPL-8 AZITHROMYCIN BIONPHARMA Labeling Approval
07/20/2023 GAVRETO
NDA #213721		 SUPPL-14 PRALSETINIB BLUEPRINT MEDICINES Labeling Approval
07/20/2023 OBETICHOLIC ACID
ANDA #214935		 ORIG-1 OBETICHOLIC ACID OPTIMUS PHARMA PRIVATE LTD Tentative Approval
07/20/2023 OMEPRAZOLE MAGNESIUM
ANDA #216096		 SUPPL-2 OMEPRAZOLE MAGNESIUM L PERRIGO CO Labeling Approval
07/20/2023 ATORVASTATIN CALCIUM
ANDA #216436		 SUPPL-1 ATORVASTATIN CALCIUM BIOCON PHARMA Labeling Approval
07/20/2023 VANFLYTA
NDA #216993		 ORIG-1 QUIZARTINIB DIHYDROCHLORIDE DAIICHI SANKYO INC Type 1 - New Molecular Entity Approval
07/21/2023 HUMALOG
BLA #020563		 SUPPL-202 INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG KWIKPEN
BLA #020563		 SUPPL-202 INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG PEN
BLA #020563		 SUPPL-202 INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-202 INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 75/25
BLA #021017		 SUPPL-146 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-146 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-146 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 50/50
BLA #021018		 SUPPL-132 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-132 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-132 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
07/21/2023 TOBRAMYCIN AND DEXAMETHASONE
ANDA #064134		 SUPPL-25 DEXAMETHASONE; TOBRAMYCIN BAUSCH AND LOMB Labeling Approval
07/21/2023 TOBRAMYCIN AND DEXAMETHASONE
ANDA #064134		 SUPPL-29 DEXAMETHASONE; TOBRAMYCIN BAUSCH AND LOMB Labeling Approval
07/21/2023 DEXASPORIN
ANDA #064135		 SUPPL-42 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE BAUSCH AND LOMB Labeling Approval
07/21/2023 LORAZEPAM
ANDA #071141		 SUPPL-53 LORAZEPAM SANDOZ Labeling Approval
07/21/2023 ANAGRELIDE HYDROCHLORIDE
ANDA #076910		 SUPPL-5 ANAGRELIDE HYDROCHLORIDE IMPAX LABS Labeling Approval
07/21/2023 TORSEMIDE
ANDA #076943		 SUPPL-4 TORSEMIDE HIKMA Labeling Approval
07/21/2023 ALPRAZOLAM
ANDA #077741		 SUPPL-4 ALPRAZOLAM APOTEX INC Labeling Approval
07/21/2023 ALPRAZOLAM
ANDA #077741		 SUPPL-5 ALPRAZOLAM APOTEX INC Labeling Approval
07/21/2023 NAPROXEN SODIUM
ANDA #090545		 SUPPL-1 NAPROXEN SODIUM MARKSANS PHARMA Labeling Approval
07/21/2023 NAPROXEN SODIUM
ANDA #090545		 SUPPL-2 NAPROXEN SODIUM MARKSANS PHARMA Labeling Approval
07/21/2023 NAPROXEN SODIUM
ANDA #090545		 SUPPL-4 NAPROXEN SODIUM MARKSANS PHARMA Labeling Approval
07/21/2023 HUMALOG KWIKPEN
BLA #205747		 SUPPL-28 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
07/21/2023 LURASIDONE HYDROCHLORIDE
ANDA #208052		 SUPPL-1 LURASIDONE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
07/21/2023 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209468		 SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
07/21/2023 LEVOTHYROXINE SODIUM
ANDA #209713		 SUPPL-16 LEVOTHYROXINE SODIUM LUPIN Labeling Approval
07/21/2023 LEVOTHYROXINE SODIUM
ANDA #209713		 SUPPL-29 LEVOTHYROXINE SODIUM LUPIN Labeling Approval
07/21/2023 TOBRAMYCIN
ANDA #210871		 SUPPL-1 TOBRAMYCIN LUOXIN AUROVITAS Labeling Approval
07/21/2023 DIAZOXIDE
ANDA #211050		 SUPPL-10 DIAZOXIDE E5 PHARMA INC Labeling Approval
07/21/2023 CAPECITABINE
ANDA #211724		 SUPPL-2 CAPECITABINE RELIANCE LIFE Labeling Approval
07/21/2023 CAPECITABINE
ANDA #211724		 SUPPL-4 CAPECITABINE RELIANCE LIFE Labeling Approval
07/21/2023 TOBRAMYCIN
ANDA #212848		 SUPPL-2 TOBRAMYCIN ALKEM LABS LTD Labeling Approval
07/21/2023 YCANTH
NDA #212905		 ORIG-1 CANTHARIDIN VERRICA PHARMS Type 5 - New Formulation or New Manufacturer Approval
07/21/2023 VASOPRESSIN
ANDA #212944		 SUPPL-2 VASOPRESSIN AMNEAL Labeling Approval
07/21/2023 PREGABALIN
ANDA #212988		 SUPPL-1 PREGABALIN ESKAYEF Manufacturing (CMC) Approval
07/21/2023 WEGOVY
NDA #215256		 SUPPL-7 SEMAGLUTIDE NOVO Efficacy Approval
07/21/2023 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #215555		 SUPPL-2 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE AMNEAL Labeling Approval
07/21/2023 LACOSAMIDE
ANDA #216151		 SUPPL-2 LACOSAMIDE NOVITIUM PHARMA Labeling Approval
07/21/2023 LACOSAMIDE
ANDA #216151		 SUPPL-4 LACOSAMIDE NOVITIUM PHARMA Labeling Approval
07/23/2023 ROPIVACAINE HYDROCHLORIDE
ANDA #090318		 SUPPL-5 ROPIVACAINE HYDROCHLORIDE RISING Labeling Approval
07/23/2023 ROPIVACAINE HYDROCHLORIDE
ANDA #090318		 SUPPL-7 ROPIVACAINE HYDROCHLORIDE RISING Labeling Approval
07/24/2023 PLAQUENIL
NDA #009768		 SUPPL-60 HYDROXYCHLOROQUINE SULFATE CONCORDIA Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #040516		 SUPPL-16 CHLOROQUINE PHOSPHATE IMPAX LABS Labeling Approval
07/24/2023 CLONAZEPAM
ANDA #077147		 SUPPL-11 CLONAZEPAM ACCORD HLTHCARE Labeling Approval
07/24/2023 CLONAZEPAM
ANDA #077147		 SUPPL-13 CLONAZEPAM ACCORD HLTHCARE Labeling Approval
07/24/2023 CLONAZEPAM
ANDA #077147		 SUPPL-14 CLONAZEPAM ACCORD HLTHCARE Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #080880		 SUPPL-68 CHLOROQUINE PHOSPHATE IMPAX LABS Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #083082		 SUPPL-59 CHLOROQUINE PHOSPHATE HIKMA PHARMS Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #090249		 SUPPL-8 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #090610		 SUPPL-10 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #090612		 SUPPL-6 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #091621		 SUPPL-6 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
07/24/2023 COSENTYX
BLA #125504		 SUPPL-54 SECUKINUMAB NOVARTIS PHARMS CORP Approval
07/24/2023 COSENTYX
BLA #125504		 SUPPL-55 SECUKINUMAB NOVARTIS PHARMS CORP Approval
07/24/2023 COSENTYX
BLA #125504		 SUPPL-67 SECUKINUMAB NOVARTIS PHARMS CORP Approval
07/24/2023 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #201231		 SUPPL-11 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/24/2023 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #201231		 SUPPL-13 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/24/2023 PLERIXAFOR
ANDA #205182		 ORIG-1 PLERIXAFOR DR REDDYS Approval
07/24/2023 PLERIXAFOR
ANDA #205197		 ORIG-1 PLERIXAFOR TEVA PHARMS USA INC Approval
07/24/2023 PLERIXAFOR
ANDA #211901		 ORIG-1 PLERIXAFOR MSN Approval
07/24/2023 ICATIBANT ACETATE
ANDA #212446		 SUPPL-3 ICATIBANT ACETATE CIPLA Labeling Approval
07/24/2023 BUMETANIDE
ANDA #213458		 ORIG-1 BUMETANIDE TARO Approval
07/24/2023 PLERIXAFOR
ANDA #213672		 ORIG-1 PLERIXAFOR EUGIA PHARMA Approval
07/24/2023 TIROFIBAN HYDROCHLORIDE
ANDA #213947		 ORIG-2 TIROFIBAN HYDROCHLORIDE NEXUS Approval
07/24/2023 SOVUNA
NDA #214581		 SUPPL-7 HYDROXYCHLOROQUINE SULFATE NOVITIUM PHARMA Labeling Approval
07/24/2023 CHLOROQUINE PHOSPHATE
ANDA #214756		 SUPPL-4 CHLOROQUINE PHOSPHATE SUVEN PHARMS Labeling Approval
07/24/2023 PLERIXAFOR
ANDA #215334		 ORIG-1 PLERIXAFOR AMNEAL Approval
07/24/2023 PLERIXAFOR
ANDA #215698		 ORIG-1 PLERIXAFOR KINDOS Approval
07/24/2023 XDEMVY
NDA #217603		 ORIG-1 LOTILANER TARSUS Type 1 - New Molecular Entity Approval
07/25/2023 METOPIRONE
NDA #012911		 SUPPL-39 METYRAPONE HRA PHARMA Labeling Approval
07/25/2023 TAMOXIFEN CITRATE
ANDA #074732		 SUPPL-15 TAMOXIFEN CITRATE MYLAN Manufacturing (CMC) Approval
07/25/2023 TAMSULOSIN HYDROCHLORIDE
ANDA #090377		 SUPPL-11 TAMSULOSIN HYDROCHLORIDE IMPAX LABS Labeling Approval
07/25/2023 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-25 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
07/25/2023 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-26 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
07/25/2023 ATORVASTATIN CALCIUM
ANDA #090548		 SUPPL-27 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
07/25/2023 DOXYCYCLINE HYCLATE
ANDA #207289		 SUPPL-7 DOXYCYCLINE HYCLATE AMNEAL PHARMS Labeling Approval
07/25/2023 DOXYCYCLINE HYCLATE
ANDA #207774		 SUPPL-4 DOXYCYCLINE HYCLATE ZYDUS LIFESCIENCES Labeling Approval
07/25/2023 RANOLAZINE
ANDA #213085		 ORIG-1 RANOLAZINE PIRAMAL HLTHCARE UK Approval
07/25/2023 FOSAPREPITANT DIMEGLUMINE
ANDA #213106		 SUPPL-3 FOSAPREPITANT DIMEGLUMINE QILU PHARM HAINAN Labeling Approval
07/25/2023 FOSAPREPITANT DIMEGLUMINE
ANDA #213106		 SUPPL-5 FOSAPREPITANT DIMEGLUMINE QILU PHARM HAINAN Labeling Approval
07/25/2023 CARBOPROST TROMETHAMINE
ANDA #216897		 ORIG-1 CARBOPROST TROMETHAMINE STERISCIENCE Approval
07/25/2023 VARENICLINE TARTRATE
ANDA #217151		 ORIG-1 VARENICLINE TARTRATE LEADING PHARMA Approval
07/26/2023 HIBICLENS
NDA #017768		 SUPPL-59 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Labeling Approval
07/26/2023 COREG
NDA #020297		 SUPPL-39 CARVEDILOL WAYLIS THERAP Labeling Approval
07/26/2023 COREG CR
NDA #022012		 SUPPL-24 CARVEDILOL PHOSPHATE WAYLIS THERAP Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-54 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-55 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-56 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-57 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-58 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-59 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-60 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-61 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-72 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-74 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-77 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
07/26/2023 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-38 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/26/2023 SERTRALINE HYDROCHLORIDE
ANDA #077206		 SUPPL-39 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/26/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090865		 SUPPL-21 PRAMIPEXOLE DIHYDROCHLORIDE TORRENT PHARMS Labeling Approval
07/26/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090865		 SUPPL-22 PRAMIPEXOLE DIHYDROCHLORIDE TORRENT PHARMS Labeling Approval
07/26/2023 FEBUXOSTAT
ANDA #205414		 SUPPL-1 FEBUXOSTAT HIKMA Labeling Approval
07/26/2023 FEBUXOSTAT
ANDA #205421		 SUPPL-13 FEBUXOSTAT ALEMBIC Labeling Approval
07/26/2023 PLERIXAFOR
ANDA #208980		 ORIG-1 PLERIXAFOR ZYDUS PHARMS Approval
07/26/2023 COLESEVELAM HYDROCHLORIDE
ANDA #209946		 SUPPL-2 COLESEVELAM HYDROCHLORIDE ZHEJIANG JINGXIN Labeling Approval
07/26/2023 APREMILAST
ANDA #211878		 ORIG-1 APREMILAST ANNORA Approval
07/26/2023 BRIVARACETAM
ANDA #214918		 SUPPL-1 BRIVARACETAM LUPIN LTD Labeling Approval
07/26/2023 MEROPENEM
NDA #215212		 ORIG-1 MEROPENEM HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
07/26/2023 ELZONRIS
BLA #761116		 SUPPL-9 TAGRAXOFUSP-ERZS STEMLINE THERAPEUTICS INC Approval
07/26/2023 TIVDAK
BLA #761208		 SUPPL-5 TISOTUMAB VEDOTIN-TFTV SEAGEN Approval
07/27/2023 SOMAVERT
BLA #021106		 SUPPL-74 PEGVISOMANT PHARMACIA Approval
07/27/2023 CRESTOR
NDA #021366		 SUPPL-45 ROSUVASTATIN CALCIUM IPR Labeling Approval
07/27/2023 MIRALAX
NDA #022015		 SUPPL-47 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
07/27/2023 NESINA
NDA #022271		 SUPPL-15 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Efficacy Approval
07/27/2023 KEPIVANCE
BLA #125103		 SUPPL-186 PALIFERMIN BIOVITRUM AB Approval
07/27/2023 ULSPIRA
ANDA #203144		 ORIG-1 NITRIC OXIDE AIRGAS THERAP Approval
07/27/2023 KAZANO
NDA #203414		 SUPPL-16 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
07/27/2023 GALLIUM GA 68 EDOTREOTIDE
NDA #210828		 SUPPL-3 GALLIUM GA-68 EDOTREOTIDE UIHC PET IMAGING Labeling Approval
07/27/2023 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
NDA #215700		 SUPPL-2 NOREPINEPHRINE BITARTRATE INFORLIFE Labeling Approval
07/27/2023 AZITHROMYCIN
ANDA #217036		 ORIG-1 AZITHROMYCIN HAINAN POLY Approval
07/27/2023 TOBRAMYCIN
ANDA #217344		 ORIG-1 TOBRAMYCIN MICRO LABS Approval
07/28/2023 LOVENOX
NDA #020164		 SUPPL-101 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
07/28/2023 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-101 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
07/28/2023 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-26 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/28/2023 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-27 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/28/2023 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-29 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/28/2023 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-32 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/28/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-27 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
07/28/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-31 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
07/28/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-33 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
07/28/2023 BETASERON
BLA #103471		 SUPPL-5202 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
07/28/2023 AVONEX
BLA #103628		 SUPPL-5269 INTERFERON BETA-1A BIOGEN Approval
07/28/2023 REBIF
BLA #103780		 SUPPL-5214 INTERFERON BETA-1A SERONO INC Approval
07/28/2023 PLEGRIDY
BLA #125499		 SUPPL-28 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
07/28/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289		 SUPPL-19 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
07/28/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289		 SUPPL-36 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
07/28/2023 CALCITRIOL
ANDA #203973		 ORIG-1 CALCITRIOL PATRIN Approval
07/28/2023 BUPROPION HYDROCHLORIDE
ANDA #205794		 SUPPL-28 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
07/28/2023 CINACALCET HYDROCHLORIDE
ANDA #206125		 SUPPL-8 CINACALCET HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/28/2023 DICLOFENAC SODIUM
ANDA #206298		 SUPPL-1 DICLOFENAC SODIUM TARO Labeling Approval
07/28/2023 DICLOFENAC SODIUM
ANDA #206298		 SUPPL-7 DICLOFENAC SODIUM TARO Labeling Approval
07/28/2023 DICLOFENAC SODIUM
ANDA #206298		 SUPPL-8 DICLOFENAC SODIUM TARO Labeling Approval
07/28/2023 CLOPIDOGREL BISULFATE
ANDA #206376		 SUPPL-3 CLOPIDOGREL BISULFATE PRINSTON INC Labeling Approval
07/28/2023 CLOPIDOGREL BISULFATE
ANDA #206376		 SUPPL-4 CLOPIDOGREL BISULFATE PRINSTON INC Labeling Approval
07/28/2023 LAMOTRIGINE
ANDA #206382		 SUPPL-12 LAMOTRIGINE SCIEGEN PHARMS INC Labeling Approval
07/28/2023 LAMOTRIGINE
ANDA #206382		 SUPPL-13 LAMOTRIGINE SCIEGEN PHARMS INC Labeling Approval
07/28/2023 LAMOTRIGINE
ANDA #206382		 SUPPL-14 LAMOTRIGINE SCIEGEN PHARMS INC Labeling Approval
07/28/2023 NOXIVENT
ANDA #207141		 SUPPL-4 NITRIC OXIDE LINDE GAS EQUIP Labeling Approval
07/28/2023 SIROLIMUS
ANDA #211212		 SUPPL-1 SIROLIMUS AMNEAL Labeling Approval
07/28/2023 SIROLIMUS
ANDA #211212		 SUPPL-4 SIROLIMUS AMNEAL Labeling Approval
07/28/2023 SUCCINYLCHOLINE CHLORIDE
ANDA #211432		 SUPPL-11 SUCCINYLCHOLINE CHLORIDE AMNEAL Labeling Approval
07/28/2023 LORATADINE
ANDA #211718		 ORIG-1 LORATADINE HETERO LABS LTD V Approval
07/28/2023 BRINZOLAMIDE
ANDA #211914		 ORIG-1 BRINZOLAMIDE PADAGIS US Approval
07/28/2023 TRIFERIC AVNU
NDA #212860		 SUPPL-1 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
07/28/2023 PHYTONADIONE
ANDA #213329		 ORIG-1 PHYTONADIONE SCIEGEN PHARMS INC Approval
07/28/2023 ZEPZELCA
NDA #213702		 SUPPL-8 LURBINECTEDIN JAZZ Labeling Approval
07/28/2023 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #214891		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE GENEYORK PHARMS Approval
07/28/2023 MOUNJARO
NDA #215866		 SUPPL-2 TIRZEPATIDE ELI LILLY AND CO Labeling Approval
07/28/2023 MOUNJARO
NDA #215866		 SUPPL-6 TIRZEPATIDE ELI LILLY AND CO Labeling Approval
07/28/2023 MOUNJARO (AUTOINJECTOR)
NDA #215866		 SUPPL-2 TIRZEPATIDE ELI LILLY AND CO Labeling Approval
07/28/2023 MOUNJARO (AUTOINJECTOR)
NDA #215866		 SUPPL-6 TIRZEPATIDE ELI LILLY AND CO Labeling Approval
07/28/2023 RIVIVE
NDA #217722		 ORIG-1 NALOXONE HYDROCHLORIDE HARM REDUCTION THERP Type 5 - New Formulation or New Manufacturer Approval
07/31/2023 SIMVASTATIN
ANDA #076052		 SUPPL-44 SIMVASTATIN IVAX SUB TEVA PHARMS Labeling Approval
07/31/2023 SIMVASTATIN
ANDA #076052		 SUPPL-48 SIMVASTATIN IVAX SUB TEVA PHARMS Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-9 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-10 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-11 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077296		 SUPPL-12 DIVALPROEX SODIUM CHARTWELL RX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-18 DIVALPROEX SODIUM APOTEX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-19 DIVALPROEX SODIUM APOTEX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-20 DIVALPROEX SODIUM APOTEX Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-21 DIVALPROEX SODIUM APOTEX Labeling Approval
07/31/2023 SIMVASTATIN
ANDA #077691		 SUPPL-47 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
07/31/2023 SIMVASTATIN
ANDA #078155		 SUPPL-39 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
07/31/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-40 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-25 DIVALPROEX SODIUM LUPIN Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-26 DIVALPROEX SODIUM LUPIN Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-27 DIVALPROEX SODIUM LUPIN Labeling Approval
07/31/2023 DIVALPROEX SODIUM
ANDA #078790		 SUPPL-28 DIVALPROEX SODIUM LUPIN Labeling Approval
07/31/2023 SIMVASTATIN
ANDA #200895		 SUPPL-13 SIMVASTATIN HETERO LABS LTD III Labeling Approval
07/31/2023 LEVONORGESTREL
ANDA #202739		 SUPPL-4 LEVONORGESTREL MYLAN LABS LTD Labeling Approval
07/31/2023 LEVONORGESTREL
ANDA #202739		 SUPPL-5 LEVONORGESTREL MYLAN LABS LTD Labeling Approval
07/31/2023 TURQOZ
ANDA #202980		 ORIG-1 ETHINYL ESTRADIOL; NORGESTREL LUPIN LTD Approval
07/31/2023 ASHLYNA
ANDA #203163		 SUPPL-3 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Labeling Approval
07/31/2023 ASHLYNA
ANDA #203163		 SUPPL-5 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-4 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-10 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-13 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-16 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-20 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-22 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
07/31/2023 SAXAGLIPTIN
ANDA #205941		 ORIG-1 SAXAGLIPTIN HYDROCHLORIDE AMNEAL Approval
07/31/2023 SAXAGLIPTIN
ANDA #205972		 ORIG-1 SAXAGLIPTIN HYDROCHLORIDE AUROBINDO PHARMA Approval
07/31/2023 SAXAGLIPTIN
ANDA #205980		 ORIG-1 SAXAGLIPTIN HYDROCHLORIDE MYLAN Approval
07/31/2023 SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #205981		 ORIG-1 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE MYLAN Approval
07/31/2023 SAXAGLIPTIN
ANDA #205994		 ORIG-1 SAXAGLIPTIN HYDROCHLORIDE GLENMARK PHARMS LTD Approval
07/31/2023 SAXAGLIPTIN
ANDA #206078		 ORIG-1 SAXAGLIPTIN HYDROCHLORIDE SUN PHARM Approval
07/31/2023 SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #206081		 ORIG-1 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE SUN PHARM Approval
07/31/2023 FLUOCINOLONE ACETONIDE
ANDA #207345		 ORIG-1 FLUOCINOLONE ACETONIDE NOVEL LABS INC Approval
07/31/2023 ARTESUNATE
NDA #213036		 SUPPL-4 ARTESUNATE AMIVAS Labeling Approval
07/31/2023 ESLICARBAZEPINE ACETATE
ANDA #216481		 ORIG-1 ESLICARBAZEPINE ACETATE AUROBINDO PHARMA LTD Tentative Approval
07/31/2023 ARGATROBAN
ANDA #217848		 ORIG-1 ARGATROBAN GLAND PHARMA LTD Approval
07/31/2023 JEMPERLI
BLA #761174		 SUPPL-6 DOSTARLIMAB-GXLY GLAXOSMITHKLINE Approval
Back to Top