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Drugs@FDA: FDA-Approved Drugs

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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.

 

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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
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