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
September 2024

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 September 19, 2024.

 

< Previous Month     Next Month >
Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/03/2024 LINAGLIPTIN
ANDA #208423		 ORIG-1 LINAGLIPTIN INVAGEN PHARMS Approval
09/03/2024 ICATIBANT ACETATE
ANDA #210118		 SUPPL-6 ICATIBANT ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
09/03/2024 IBUPROFEN
ANDA #215311		 SUPPL-1 IBUPROFEN STRIDES PHARMA Manufacturing (CMC) Approval
09/04/2024 TRILEPTAL
NDA #021014		 SUPPL-50 OXCARBAZEPINE NOVARTIS Labeling Approval
09/04/2024 TRILEPTAL
NDA #021285		 SUPPL-42 OXCARBAZEPINE NOVARTIS Labeling Approval
09/04/2024 CASPOFUNGIN ACETATE
ANDA #200833		 SUPPL-7 CASPOFUNGIN ACETATE HENGRUI PHARMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204082		 SUPPL-7 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204082		 SUPPL-8 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204082		 SUPPL-11 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204083		 SUPPL-6 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204083		 SUPPL-7 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 DESVENLAFAXINE SUCCINATE
ANDA #204083		 SUPPL-10 DESVENLAFAXINE SUCCINATE HIKMA Labeling Approval
09/04/2024 EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212375		 ORIG-1 EMPAGLIFLOZIN;LINAGLIPTIN MACLEODS PHARMS LTD Tentative Approval
09/04/2024 LACOSAMIDE
ANDA #213109		 ORIG-1 LACOSAMIDE UNICHEM Approval
09/04/2024 ALBENDAZOLE
ANDA #215652		 ORIG-1 ALBENDAZOLE ALEMBIC Approval
09/05/2024 CYTOXAN
NDA #012142		 SUPPL-116 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
09/05/2024 CYTOXAN (LYOPHILIZED)
NDA #012142		 SUPPL-116 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
09/05/2024 LYOPHILIZED CYTOXAN
NDA #012142		 SUPPL-116 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
09/05/2024 HYDROXYCHLOROQUINE SULFATE
ANDA #040104		 SUPPL-36 HYDROXYCHLOROQUINE SULFATE SANDOZ Labeling Approval
09/05/2024 HYDROXYCHLOROQUINE SULFATE
ANDA #040104		 SUPPL-37 HYDROXYCHLOROQUINE SULFATE SANDOZ Labeling Approval
09/05/2024 HYDROXYCHLOROQUINE SULFATE
ANDA #040104		 SUPPL-38 HYDROXYCHLOROQUINE SULFATE SANDOZ Labeling Approval
09/05/2024 TICAGRELOR
ANDA #208597		 SUPPL-1 TICAGRELOR MYLAN Labeling Approval
09/05/2024 TICAGRELOR
ANDA #208597		 SUPPL-2 TICAGRELOR MYLAN Labeling Approval
09/05/2024 ZILRETTA
NDA #208845		 SUPPL-19 TRIAMCINOLONE ACETONIDE PACIRA PHARMS INC Labeling Approval
09/05/2024 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
ANDA #209061		 ORIG-1 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Approval
09/05/2024 LUCEMYRA
NDA #209229		 SUPPL-7 LOFEXIDINE HYDROCHLORIDE USWM Labeling Approval
09/05/2024 IVABRADINE HYDROCHLORIDE
ANDA #213276		 ORIG-1 IVABRADINE HYDROCHLORIDE BIONPHARMA Approval
09/05/2024 BOSENTAN
ANDA #213981		 ORIG-1 BOSENTAN ZYDUS PHARMS USA INC Tentative Approval
09/05/2024 HYDROCORTISONE SODIUM SUCCINATE
ANDA #214050		 ORIG-1 HYDROCORTISONE SODIUM SUCCINATE CIPLA Approval
09/05/2024 TENOFOVIR ALAFENAMIDE
ANDA #214179		 ORIG-1 TENOFOVIR ALAFENAMIDE HETERO LABS LTD V Tentative Approval
09/05/2024 HYDROCORTISONE
ANDA #214649		 SUPPL-2 HYDROCORTISONE AUROBINDO PHARMA LTD Labeling Approval
09/05/2024 THEOPHYLLINE
ANDA #215312		 ORIG-1 THEOPHYLLINE STRIDES PHARMA Approval
09/05/2024 FILSPARI
NDA #216403		 SUPPL-3 SPARSENTAN TRAVERE Efficacy Approval
09/05/2024 NELARABINE
ANDA #216510		 ORIG-1 NELARABINE XGEN PHARMS Approval
09/05/2024 TYENNE
BLA #761275		 SUPPL-1 TOCILIZUMAB-AAZG FRESENIUS KABI USA Approval
09/06/2024 NICORETTE
NDA #021330		 SUPPL-26 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
09/06/2024 DESIPRAMINE HYDROCHLORIDE
ANDA #071588		 SUPPL-34 DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/06/2024 DESIPRAMINE HYDROCHLORIDE
ANDA #071601		 SUPPL-35 DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/06/2024 DESIPRAMINE HYDROCHLORIDE
ANDA #071602		 SUPPL-32 DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/06/2024 DESIPRAMINE HYDROCHLORIDE
ANDA #071766		 SUPPL-33 DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/06/2024 DESIPRAMINE HYDROCHLORIDE
ANDA #074430		 SUPPL-22 DESIPRAMINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/06/2024 BEXAROTENE
ANDA #208628		 ORIG-1 BEXAROTENE ASCENT PHARMS INC Approval
09/06/2024 POTASSIUM CHLORIDE
ANDA #212987		 ORIG-1 POTASSIUM CHLORIDE MACLEODS PHARMS LTD Approval
09/06/2024 EPINEPHRINE
ANDA #217192		 ORIG-1 EPINEPHRINE AM REGENT Approval
09/06/2024 NICARDIPINE HYDROCHLORIDE
ANDA #217548		 ORIG-1 NICARDIPINE HYDROCHLORIDE CHENGDU SHUODE Approval
09/06/2024 HERCESSI
BLA #761346		 SUPPL-1 TRASTUZUMAB-STRF ACCORD BIOPHARMA INC. Approval
09/09/2024 ADVIL PM
NDA #021393		 SUPPL-22 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
09/09/2024 VERAPAMIL HYDROCHLORIDE
ANDA #070737		 SUPPL-28 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
09/09/2024 LEVOFLOXACIN
ANDA #076361		 SUPPL-16 LEVOFLOXACIN TEVA Labeling Approval
09/09/2024 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024		 SUPPL-31 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/09/2024 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024		 SUPPL-35 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
09/09/2024 RISPERIDONE
ANDA #091384		 SUPPL-13 RISPERIDONE AMNEAL PHARMS Labeling Approval
09/09/2024 CHOLINE C-11
NDA #203155		 SUPPL-9 CHOLINE C-11 MCPRF Labeling Approval
09/09/2024 GABAPENTIN
ANDA #203643		 ORIG-1 GABAPENTIN INCEPTA PHARMS LTD Approval
09/09/2024 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534		 SUPPL-1 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Labeling Approval
09/09/2024 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534		 SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Labeling Approval
09/09/2024 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534		 SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Labeling Approval
09/09/2024 GABAPENTIN
ANDA #207099		 SUPPL-18 GABAPENTIN RISING Labeling Approval
09/09/2024 BUPRENORPHINE HYDROCHLORIDE
ANDA #211594		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE ALVOGEN Labeling Approval
09/09/2024 LINAGLIPTIN
ANDA #217749		 ORIG-1 LINAGLIPTIN HETERO LABS LTD Tentative Approval
09/09/2024 CABERGOLINE
ANDA #218109		 ORIG-1 CABERGOLINE WELDING Approval
09/10/2024 ESTRASORB
NDA #021371		 SUPPL-9 ESTRADIOL HEMIHYDRATE EXELTIS USA INC Labeling Approval
09/10/2024 LEVOFLOXACIN
ANDA #077097		 SUPPL-10 LEVOFLOXACIN NATCO PHARMA Labeling Approval
09/10/2024 ESTRADIOL
ANDA #204379		 SUPPL-1 ESTRADIOL ZYDUS PHARMS Labeling Approval
09/10/2024 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206931		 SUPPL-10 DEXMETHYLPHENIDATE HYDROCHLORIDE ABHAI INC Labeling Approval
09/10/2024 TOPIRAMATE
ANDA #207382		 SUPPL-9 TOPIRAMATE ZYDUS Manufacturing (CMC) Approval
09/10/2024 LEVOTHYROXINE SODIUM
ANDA #207588		 SUPPL-6 LEVOTHYROXINE SODIUM WATSON LABS TEVA Labeling Approval
09/10/2024 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209211		 SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE CEDIPROF INC Labeling Approval
09/10/2024 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #210507		 ORIG-1 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE UNICHEM Approval
09/10/2024 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA #216114		 ORIG-1 BRIMONIDINE TARTRATE; TIMOLOL MALEATE SOMERSET Approval
09/10/2024 ELREXFIO
BLA #761345		 SUPPL-2 ELRANATAMAB PFIZER INC Approval
09/11/2024 ALEVE
NDA #020204		 SUPPL-88 NAPROXEN SODIUM BAYER Labeling Approval
09/11/2024 DABIGATRAN ETEXILATE MESYLATE
ANDA #208040		 ORIG-2 DABIGATRAN ETEXILATE MESYLATE ALKEM LABS LTD Approval
09/11/2024 VUMERITY
NDA #211855		 SUPPL-17 DIROXIMEL FUMARATE BIOGEN INC Manufacturing (CMC) Approval
09/11/2024 BUSULFAN
ANDA #215235		 ORIG-1 BUSULFAN PRINSTON INC Approval
09/11/2024 LENALIDOMIDE
ANDA #217281		 ORIG-1 LENALIDOMIDE NOVUGEN Approval
09/11/2024 AMIODARONE HYDROCHLORIDE
ANDA #218253		 ORIG-1 AMIODARONE HYDROCHLORIDE ZHEJIANG POLY PHARM Approval
09/11/2024 TREMFYA
BLA #761061		 SUPPL-21 GUSELKUMAB JANSSEN BIOTECH Approval
09/12/2024 CLOZARIL
NDA #019758		 SUPPL-104 CLOZAPINE HERITAGE LIFE Labeling Approval
09/12/2024 SABRIL
NDA #020427		 SUPPL-27 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
09/12/2024 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-22 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
09/12/2024 SABRIL
NDA #022006		 SUPPL-28 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
09/12/2024 INVEGA SUSTENNA
NDA #022264		 SUPPL-37 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
09/12/2024 DILTIAZEM HYDROCHLORIDE
ANDA #074910		 SUPPL-19 DILTIAZEM HYDROCHLORIDE MYLAN Labeling Approval
09/12/2024 DICLOFENAC SODIUM
ANDA #075910		 SUPPL-30 DICLOFENAC SODIUM ACTAVIS ELIZABETH Labeling Approval
09/12/2024 DICLOFENAC SODIUM
ANDA #076152		 SUPPL-15 DICLOFENAC SODIUM AUROBINDO PHARMA USA Labeling Approval
09/12/2024 CIPROFLOXACIN EXTENDED RELEASE
ANDA #077809		 SUPPL-9 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE ANI PHARMS Labeling Approval
09/12/2024 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078166		 SUPPL-16 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/12/2024 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-22 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
09/12/2024 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-24 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
09/12/2024 GEMCITABINE HYDROCHLORIDE
ANDA #090242		 SUPPL-4 GEMCITABINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/12/2024 ENBREL
BLA #103795		 SUPPL-5600 ETANERCEPT IMMUNEX Approval
09/12/2024 NAGLAZYME
BLA #125117		 SUPPL-132 GALSULFASE BIOMARIN Approval
09/12/2024 INVEGA HAFYERA
NDA #207946		 SUPPL-14 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
09/12/2024 INVEGA HAFYERA
NDA #207946		 SUPPL-15 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
09/12/2024 INVEGA TRINZA
NDA #207946		 SUPPL-14 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
09/12/2024 INVEGA TRINZA
NDA #207946		 SUPPL-15 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
09/12/2024 VIGABATRIN
ANDA #208218		 SUPPL-15 VIGABATRIN ENDO OPERATIONS REMS Approval
09/12/2024 VIGABATRIN
ANDA #209822		 SUPPL-12 VIGABATRIN TEVA PHARMS USA REMS Approval
09/12/2024 VIGABATRIN
ANDA #209824		 SUPPL-13 VIGABATRIN TEVA PHARMS USA REMS Approval
09/12/2024 VIGABATRIN
ANDA #210042		 SUPPL-6 VIGABATRIN AMNEAL PHARMS REMS Approval
09/12/2024 VIGABATRIN
ANDA #210155		 SUPPL-19 VIGABATRIN AMNEAL PHARMS REMS Approval
09/12/2024 VIGADRONE
ANDA #210196		 SUPPL-20 VIGABATRIN AUCTA REMS Approval
09/12/2024 TICAGRELOR
ANDA #210219		 ORIG-1 TICAGRELOR ALKEM LABS LTD Tentative Approval
09/12/2024 BRAFTOVI
NDA #210496		 SUPPL-16 ENCORAFENIB ARRAY BIOPHARMA INC Efficacy Approval
09/12/2024 MEKTOVI
NDA #210498		 SUPPL-10 BINIMETINIB ARRAY BIOPHARMA INC Efficacy Approval
09/12/2024 VIGABATRIN
ANDA #211481		 SUPPL-9 VIGABATRIN DR REDDYS REMS Approval
09/12/2024 VIGABATRIN
ANDA #211539		 SUPPL-2 VIGABATRIN DR REDDYS REMS Approval
09/12/2024 VIGABATRIN
ANDA #211592		 SUPPL-9 VIGABATRIN INVAGEN PHARMS REMS Approval
09/12/2024 VIGABATRIN
ANDA #213104		 SUPPL-2 VIGABATRIN HIKMA REMS Approval
09/12/2024 VIGABATRIN
ANDA #213375		 SUPPL-5 VIGABATRIN ALKEM LABS LTD REMS Approval
09/12/2024 VIGABATRIN
ANDA #213390		 SUPPL-3 VIGABATRIN PROPEL PHARMA REMS Approval
09/12/2024 VIGABATRIN
ANDA #213469		 SUPPL-5 VIGABATRIN GRANULES REMS Approval
09/12/2024 VIGABATRIN
ANDA #213519		 SUPPL-4 VIGABATRIN ANNORA PHARMA REMS Approval
09/12/2024 VIGABATRIN
ANDA #213899		 SUPPL-4 VIGABATRIN AUROBINDO PHARMA LTD REMS Approval
09/12/2024 METHOTREXATE
NDA #214121		 SUPPL-3 METHOTREXATE ACCORD HLTHCARE Labeling Approval
09/12/2024 VIGABATRIN
ANDA #214425		 SUPPL-4 VIGABATRIN ACCORD HLTHCARE REMS Approval
09/12/2024 VIGABATRIN
ANDA #214671		 SUPPL-1 VIGABATRIN ZYDUS LIFESCIENCES REMS Approval
09/12/2024 VIGABATRIN
ANDA #214749		 SUPPL-1 VIGABATRIN UPSHER SMITH LABS REMS Approval
09/12/2024 VIGPODER
ANDA #214961		 SUPPL-7 VIGABATRIN PYROS PHARMS REMS Approval
09/12/2024 VIGABATRIN
ANDA #214992		 SUPPL-3 VIGABATRIN DEXCEL REMS Approval
09/12/2024 VIGABATRIN
ANDA #215109		 SUPPL-3 VIGABATRIN DEXCEL REMS Approval
09/12/2024 VIGABATRIN
ANDA #215363		 SUPPL-2 VIGABATRIN MSN REMS Approval
09/12/2024 VIGABATRIN
ANDA #215519		 SUPPL-1 VIGABATRIN PROPEL PHARMA REMS Approval
09/12/2024 VIGABATRIN
ANDA #215601		 SUPPL-3 VIGABATRIN AUROBINDO PHARMA LTD REMS Approval
09/12/2024 VIGABATRIN
ANDA #215707		 SUPPL-3 VIGABATRIN ZYDUS LIFESCIENCES REMS Approval
09/12/2024 PAXLOVID (COPACKAGED)
NDA #217188		 SUPPL-6 NIRMATRELVIR; RITONAVIR PFIZER Labeling Approval
09/12/2024 VIGAFYDE
NDA #217684		 SUPPL-1 VIGABATRIN PYROS PHARMS REMS Approval
09/12/2024 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #218936		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE GRAVITI PHARMS Approval
09/12/2024 DUPIXENT
BLA #761055		 SUPPL-66 DUPILUMAB REGENERON PHARMACEUTICALS Approval
09/12/2024 TECENTRIQ HYBREZA
NDA #761347		 ORIG-1 ATEZOLIZUMAB;HYALURONIDASE-TQJS GENENTECH INC Type 3 - New Dosage Form Approval
09/13/2024 QSYMIA
NDA #022580		 SUPPL-25 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Efficacy Approval
09/13/2024 CIMZIA
BLA #125160		 SUPPL-275 CERTOLIZUMAB PEGOL UCB INC Approval
09/13/2024 ERLOTINIB HYDROCHLORIDE
ANDA #203843		 ORIG-1 ERLOTINIB HYDROCHLORIDE HIKMA Approval
09/13/2024 PROCHLORPERAZINE EDISYLATE
ANDA #212257		 ORIG-1 PROCHLORPERAZINE EDISYLATE SOMERSET THERAPS LLC Approval
09/13/2024 FLUOXETINE HYDROCHLORIDE
ANDA #212683		 ORIG-1 FLUOXETINE HYDROCHLORIDE STRIDES PHARMA Approval
09/13/2024 NELARABINE
ANDA #216948		 ORIG-1 NELARABINE MSN Approval
09/13/2024 EBGLYSS
BLA #761306		 ORIG-1 LEBRIKIZUMAB-LBKZ ELI LILLY AND CO Approval
09/13/2024 OCREVUS ZUNOVO
BLA #761371		 ORIG-1 OCRELIZUMAB;HYALURONIDASE-OCSQ GENENTECH INC Approval
09/16/2024 CHEMET
NDA #019998		 SUPPL-23 SUCCIMER RECORDATI RARE Labeling Approval
09/16/2024 SANCUSO
NDA #022198		 SUPPL-23 GRANISETRON CUMBERLAND Labeling Approval
09/16/2024 ZYCLARA
NDA #022483		 SUPPL-11 IMIQUIMOD BAUSCH Labeling Approval
09/16/2024 MEDROXYPROGESTERONE ACETATE
ANDA #040159		 SUPPL-34 MEDROXYPROGESTERONE ACETATE BARR Labeling Approval
09/16/2024 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-42 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
09/16/2024 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-45 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
09/16/2024 LEVETIRACETAM
ANDA #090992		 SUPPL-11 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
09/16/2024 LANSOPRAZOLE
ANDA #200816		 SUPPL-4 LANSOPRAZOLE ZYDUS PHARMS Labeling Approval
09/16/2024 LEVOFLOXACIN
ANDA #200839		 SUPPL-31 LEVOFLOXACIN MACLEODS PHARMS LTD Labeling Approval
09/16/2024 LEVOFLOXACIN
ANDA #200839		 SUPPL-33 LEVOFLOXACIN MACLEODS PHARMS LTD Labeling Approval
09/16/2024 LISDEXAMFETAMINE DIMESYLATE
ANDA #202802		 SUPPL-2 LISDEXAMFETAMINE DIMESYLATE ACTAVIS ELIZABETH Labeling Approval
09/16/2024 LISDEXAMFETAMINE DIMESYLATE
ANDA #202830		 SUPPL-2 LISDEXAMFETAMINE DIMESYLATE AMNEAL Labeling Approval
09/16/2024 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 SUPPL-2 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Labeling Approval
09/16/2024 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 SUPPL-4 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Labeling Approval
09/16/2024 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 SUPPL-7 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Labeling Approval
09/16/2024 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 SUPPL-8 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Labeling Approval
09/16/2024 CLOBAZAM
ANDA #210039		 SUPPL-9 CLOBAZAM AMNEAL Labeling Approval
09/16/2024 TIMOLOL MALEATE
ANDA #210640		 ORIG-1 TIMOLOL MALEATE SOMERSET THERAPS LLC Approval
09/16/2024 FOSAPREPITANT DIMEGLUMINE
ANDA #212143		 SUPPL-2 FOSAPREPITANT DIMEGLUMINE CHIA TAI TIANQING Labeling Approval
09/16/2024 LEVOTHYROXINE SODIUM
ANDA #212399		 SUPPL-6 LEVOTHYROXINE SODIUM ACCORD HLTHCARE Labeling Approval
09/16/2024 LEVOTHYROXINE SODIUM
ANDA #212399		 SUPPL-8 LEVOTHYROXINE SODIUM ACCORD HLTHCARE Labeling Approval
09/16/2024 SACUBITRIL AND VALSARTAN
ANDA #213764		 ORIG-1 SACUBITRIL; VALSARTAN ALKEM LABS LTD Approval
09/16/2024 SIROLIMUS
ANDA #215080		 ORIG-1 SIROLIMUS HETERO LABS LTD V Approval
09/16/2024 LANREOTIDE ACETATE
NDA #215395		 SUPPL-7 LANREOTIDE ACETATE INVAGEN PHARMS Efficacy Approval
09/16/2024 CLOBAZAM
ANDA #216008		 SUPPL-2 CLOBAZAM ACCORD HLTHCARE Labeling Approval
09/16/2024 IYUZEH
NDA #216472		 SUPPL-2 LATANOPROST THEA PHARMA Labeling Approval
09/16/2024 KETOCONAZOLE
ANDA #218498		 ORIG-1 KETOCONAZOLE NOVITIUM PHARMA Approval
09/17/2024 TRACLEER
NDA #021290		 SUPPL-45 BOSENTAN ACTELION REMS Approval
09/17/2024 LACTULOSE
ANDA #075911		 SUPPL-12 LACTULOSE XTTRIUM LABS INC Manufacturing (CMC) Approval
09/17/2024 KEYTRUDA
BLA #125514		 SUPPL-161 PEMBROLIZUMAB MERCK SHARP DOHME Approval
09/17/2024 DONEPEZIL HYDROCHLORIDE
ANDA #200292		 SUPPL-9 DONEPEZIL HYDROCHLORIDE PRINSTON INC Labeling Approval
09/17/2024 DONEPEZIL HYDROCHLORIDE
ANDA #200292		 SUPPL-11 DONEPEZIL HYDROCHLORIDE PRINSTON INC Labeling Approval
09/17/2024 BOSENTAN
ANDA #205699		 SUPPL-4 BOSENTAN ENDO OPERATIONS REMS Approval
09/17/2024 BOSENTAN
ANDA #206987		 SUPPL-5 BOSENTAN NATCO PHARMA LTD REMS Approval
09/17/2024 BOSENTAN
ANDA #207110		 SUPPL-8 BOSENTAN WATSON LABS INC REMS Approval
09/17/2024 BOSENTAN
ANDA #207760		 SUPPL-10 BOSENTAN ZYDUS PHARMS REMS Approval
09/17/2024 KISQALI
NDA #209092		 SUPPL-18 RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
09/17/2024 TRACLEER
NDA #209279		 SUPPL-11 BOSENTAN ACTELION REMS Approval
09/17/2024 BOSENTAN
ANDA #209324		 SUPPL-10 BOSENTAN SUN PHARM REMS Approval
09/17/2024 BOSENTAN
ANDA #209742		 SUPPL-9 BOSENTAN AMNEAL PHARMS CO REMS Approval
09/17/2024 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935		 SUPPL-27 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
09/17/2024 EVRYSDI
NDA #213535		 SUPPL-13 RISDIPLAM GENENTECH INC Efficacy Approval
09/17/2024 METYROSINE
ANDA #215541		 ORIG-1 METYROSINE LEADING Approval
09/17/2024 PRAZOSIN HYDROCHLORIDE
ANDA #216727		 ORIG-1 PRAZOSIN HYDROCHLORIDE MSN Approval
09/17/2024 ERTUGLIFLOZIN
ANDA #217071		 ORIG-1 ERTUGLIFLOZIN HETERO LABS LTD V Approval
09/17/2024 BUMETANIDE
ANDA #217153		 ORIG-1 BUMETANIDE LUPIN LTD Approval
09/17/2024 DEXAMETHASONE
ANDA #218372		 ORIG-1 DEXAMETHASONE COREPHARMA Approval
09/17/2024 FASENRA
BLA #761070		 SUPPL-21 BENRALIZUMAB ASTRAZENECA AB Approval
09/18/2024 ATENOLOL
ANDA #073457		 SUPPL-47 ATENOLOL MYLAN Labeling Approval
09/18/2024 RHOPRESSA
NDA #208254		 SUPPL-14 NETARSUDIL MESYLATE ALCON LABS INC Labeling Approval
Back to Top