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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 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 July 22, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/01/2023 CARVEDILOL
ANDA #078217
SUPPL-6 CARVEDILOL LUPIN Labeling Approval
11/01/2023 CARVEDILOL
ANDA #078251
SUPPL-19 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
11/01/2023 RABEPRAZOLE SODIUM
ANDA #090678
SUPPL-13 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
11/01/2023 RABEPRAZOLE SODIUM
ANDA #090678
SUPPL-14 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
11/01/2023 RABEPRAZOLE SODIUM
ANDA #090678
SUPPL-16 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
11/01/2023 RABEPRAZOLE SODIUM
ANDA #090678
SUPPL-18 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
11/01/2023 ACETYLCYSTEINE
ANDA #205643
ORIG-1 ACETYLCYSTEINE EXELA PHARMA Approval
11/01/2023 DESVENLAFAXINE SUCCINATE
ANDA #210014
SUPPL-17 DESVENLAFAXINE SUCCINATE YICHANG HUMANWELL Labeling Approval
11/01/2023 DAPSONE
ANDA #212657
ORIG-1 DAPSONE PADAGIS ISRAEL Approval
11/01/2023 UZEDY
NDA #213586
SUPPL-1 RISPERIDONE TEVA Labeling Approval
11/01/2023 VOQUEZNA
NDA #215151
ORIG-1 VONOPRAZAN FUMARATE PHATHOM Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
11/01/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #215622
SUPPL-1 VENLAFAXINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
11/01/2023 PANTOPRAZOLE SODIUM
ANDA #215860
SUPPL-4 PANTOPRAZOLE SODIUM MEITHEAL Labeling Approval
11/01/2023 ARIPIPRAZOLE
ANDA #216150
ORIG-1 ARIPIPRAZOLE HETERO LABS LTD III Approval
11/01/2023 MIDODRINE HYDROCHLORIDE
ANDA #217271
ORIG-1 MIDODRINE HYDROCHLORIDE MANKIND PHARMA Approval
11/01/2023 SARCLISA
BLA #761113
SUPPL-9 ISATUXIMAB-IRFC SANOFI AVENTIS US Approval
11/02/2023 PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
NDA #050638
SUPPL-21 PENICILLIN G POTASSIUM BAXTER HLTHCARE Labeling Approval
11/02/2023 GALANTAMINE HYDROBROMIDE
ANDA #078185
SUPPL-8 GALANTAMINE HYDROBROMIDE HIKMA Manufacturing (CMC) Approval
11/02/2023 TAMSULOSIN HYDROCHLORIDE
ANDA #078801
SUPPL-14 TAMSULOSIN HYDROCHLORIDE SYNTHON PHARMS Labeling Approval
11/02/2023 ROPINIROLE HYDROCHLORIDE
ANDA #078881
SUPPL-25 ROPINIROLE HYDROCHLORIDE MYLAN Labeling Approval
11/02/2023 RISPERIDONE
ANDA #091537
SUPPL-11 RISPERIDONE DASH PHARMS Labeling Approval
11/02/2023 RISPERIDONE
ANDA #091537
SUPPL-13 RISPERIDONE DASH PHARMS Labeling Approval
11/02/2023 PROVAYBLUE
NDA #204630
SUPPL-22 METHYLENE BLUE PROVEPHARM SAS Labeling Approval
11/02/2023 NEOSTIGMINE METHYLSULFATE
ANDA #213244
ORIG-1 NEOSTIGMINE METHYLSULFATE EUGIA PHARMA Approval
11/02/2023 BREXPIPRAZOLE
ANDA #213659
ORIG-1 BREXPIPRAZOLE AUROBINDO PHARMA LTD Approval
11/02/2023 FLUPHENAZINE DECANOATE
ANDA #215365
ORIG-1 FLUPHENAZINE DECANOATE MSN Approval
11/02/2023 FLUOROURACIL
ANDA #215612
ORIG-1 FLUOROURACIL ENCUBE Approval
11/03/2023 SANDOSTATIN
NDA #019667
SUPPL-76 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
11/03/2023 CLINDESSE
NDA #050793
SUPPL-31 CLINDAMYCIN PHOSPHATE PADAGIS US Labeling Approval
11/03/2023 VANCOMYCIN HYDROCHLORIDE
ANDA #090439
SUPPL-1 VANCOMYCIN HYDROCHLORIDE LUPIN LTD Labeling Approval
11/03/2023 VANCOMYCIN HYDROCHLORIDE
ANDA #090439
SUPPL-2 VANCOMYCIN HYDROCHLORIDE LUPIN LTD Labeling Approval
11/03/2023 VANCOMYCIN HYDROCHLORIDE
ANDA #090439
SUPPL-4 VANCOMYCIN HYDROCHLORIDE LUPIN LTD Labeling Approval
11/03/2023 VANCOMYCIN HYDROCHLORIDE
ANDA #090439
SUPPL-5 VANCOMYCIN HYDROCHLORIDE LUPIN LTD Labeling Approval
11/03/2023 VANCOMYCIN HYDROCHLORIDE
ANDA #090439
SUPPL-6 VANCOMYCIN HYDROCHLORIDE LUPIN LTD Labeling Approval
11/03/2023 HUMIRA
BLA #125057
SUPPL-423 ADALIMUMAB ABBVIE INC Approval
11/03/2023 RIVAROXABAN
ANDA #208557
ORIG-1 RIVAROXABAN TARO PHARM INDS LTD Tentative Approval
11/03/2023 VITRAKVI
NDA #210861
SUPPL-10 LAROTRECTINIB SULFATE BAYER HLTHCARE Labeling Approval
11/03/2023 VITRAKVI
NDA #211710
SUPPL-9 LAROTRECTINIB SULFATE BAYER HEALTHCARE Labeling Approval
11/03/2023 DOVATO
NDA #211994
SUPPL-20 DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Manufacturing (CMC) Approval
11/03/2023 SUGAMMADEX
ANDA #214307
ORIG-1 SUGAMMADEX EUGIA PHARMA SPECLTS Tentative Approval
11/03/2023 METHYLPREDNISOLONE ACETATE
ANDA #216502
ORIG-1 METHYLPREDNISOLONE ACETATE AMNEAL Approval
11/03/2023 ZITUVIMET
NDA #216743
ORIG-1 METFORMIN HYDROCHLORIDE; SITAGLIPTIN ZYDUS LIFESCIENCES Type 5 - New Formulation or New Manufacturer Approval
11/03/2023 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #217073
ORIG-1 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE OMSAV PHARMA Approval
11/06/2023 IDAMYCIN PFS
NDA #050734
SUPPL-31 IDARUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
11/06/2023 LYNPARZA
NDA #208558
SUPPL-28 OLAPARIB ASTRAZENECA Efficacy Approval
11/06/2023 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #212558
ORIG-1 CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE LUPIN LTD Tentative Approval
11/06/2023 BRIVARACETAM
ANDA #214875
ORIG-1 BRIVARACETAM APOTEX INC Tentative Approval
11/06/2023 FLUPHENAZINE HYDROCHLORIDE
ANDA #216350
ORIG-1 FLUPHENAZINE HYDROCHLORIDE GLENMARK PHARMS LTD Approval
11/07/2023 INDERAL LA
NDA #018553
SUPPL-48 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
11/07/2023 INDERAL LA
NDA #018553
SUPPL-52 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Labeling Approval
11/07/2023 REYATAZ
NDA #021567
SUPPL-48 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-5 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-6 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-10 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-12 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-14 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 TRAMADOL HYDROCHLORIDE
ANDA #090404
SUPPL-16 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/07/2023 KEYTRUDA
BLA #125514
SUPPL-148 PEMBROLIZUMAB MERCK SHARP DOHME Approval
11/07/2023 MESALAMINE
ANDA #203286
SUPPL-14 MESALAMINE ZYDUS PHARMS Labeling Approval
11/07/2023 BALSALAZIDE DISODIUM
ANDA #206336
SUPPL-2 BALSALAZIDE DISODIUM STRIDES PHARMA Labeling Approval
11/07/2023 REYATAZ
NDA #206352
SUPPL-10 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
11/07/2023 LIFITEGRAST
ANDA #215063
ORIG-1 LIFITEGRAST EUGIA PHARMA Approval
11/08/2023 DURAMORPH PF
NDA #018565
SUPPL-29 MORPHINE SULFATE HIKMA Labeling Approval
11/08/2023 INFUMORPH
NDA #018565
SUPPL-29 MORPHINE SULFATE HIKMA Labeling Approval
11/08/2023 SUSTIVA
NDA #020972
SUPPL-59 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
11/08/2023 SUSTIVA
NDA #021360
SUPPL-47 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
11/08/2023 CIMZIA
BLA #125160
SUPPL-309 CERTOLIZUMAB PEGOL UCB INC Approval
11/08/2023 ZOLEDRONIC ACID
ANDA #202930
SUPPL-13 ZOLEDRONIC ACID GLAND PHARMA LTD Manufacturing (CMC) Approval
11/08/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #206055
SUPPL-2 ESOMEPRAZOLE MAGNESIUM ZYDUS PHARMS Labeling Approval
11/08/2023 SCEMBLIX
NDA #215358
SUPPL-4 ASCIMINIB HYDROCHLORIDE NOVARTIS Labeling Approval
11/08/2023 FRUZAQLA
NDA #217564
ORIG-1 FRUQUINTINIB TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
11/08/2023 BACLOFEN
ANDA #217687
ORIG-1 BACLOFEN MICRO LABS Approval
11/08/2023 ZEPBOUND
NDA #217806
ORIG-1 TIRZEPATIDE ELI LILLY AND CO Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
11/08/2023 ZEPBOUND (AUTOINJECTOR)
NDA #217806
ORIG-1 TIRZEPATIDE ELI LILLY AND CO Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
11/08/2023 CEVIMELINE HYDROCHLORIDE
ANDA #218290
ORIG-1 CEVIMELINE HYDROCHLORIDE BIONPHARMA Approval
11/09/2023 CLARITIN-D
NDA #019670
SUPPL-36 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
11/09/2023 CLARITIN-D 24 HOUR
NDA #020470
SUPPL-52 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
11/09/2023 FLUDEOXYGLUCOSE F18
NDA #021870
SUPPL-18 FLUDEOXYGLUCOSE F-18 FEINSTEIN Labeling Approval
11/09/2023 EXPAREL
NDA #022496
SUPPL-44 BUPIVACAINE PACIRA PHARMS INC Efficacy Approval
11/09/2023 TECHNETIUM TC-99M SULFUR COLLOID KIT
ANDA #213516
ORIG-1 TECHNETIUM TC-99M SULFUR COLLOID KIT JUBILANT Approval
11/09/2023 REZUROCK
NDA #214783
SUPPL-3 BELUMOSUDIL MESYLATE KADMON PHARMS LLC Labeling Approval
11/09/2023 BRIVARACETAM
ANDA #214921
ORIG-1 BRIVARACETAM MSN LABORATORIES PRIVATE LTD Tentative Approval
11/09/2023 BRIVARACETAM
ANDA #214922
ORIG-1 BRIVARACETAM MSN LABS PVT LTD Tentative Approval
11/09/2023 BRIVARACETAM
ANDA #214924
ORIG-1 BRIVARACETAM MSN LABORATORIES PRIVATE LTD Tentative Approval
11/09/2023 DICLOFENAC POTASSIUM
ANDA #215787
SUPPL-1 DICLOFENAC POTASSIUM SENORES PHARMS Manufacturing (CMC) Approval
11/09/2023 ORSERDU
NDA #217639
SUPPL-1 ELACESTRANT DIHYDROCHLORIDE STEMLINE THERAP Labeling Approval
11/13/2023 GONAL-F
BLA #021765
SUPPL-51 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/13/2023 GONAL-F RFF
BLA #021765
SUPPL-51 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/13/2023 LACOSAMIDE
ANDA #216670
ORIG-1 LACOSAMIDE APOTEX Approval
11/14/2023 CROMOLYN SODIUM
ANDA #202745
SUPPL-2 CROMOLYN SODIUM MICRO LABS LTD INDIA Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-3 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-4 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-5 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-6 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-9 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-10 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 DEFERASIROX
ANDA #209782
SUPPL-11 DEFERASIROX SUN PHARM Labeling Approval
11/14/2023 RINVOQ
NDA #211675
SUPPL-19 UPADACITINIB ABBVIE Labeling Approval
11/14/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #211977
SUPPL-9 ESOMEPRAZOLE MAGNESIUM HETERO LABS LTD III Labeling Approval
11/14/2023 PRADAXA
NDA #214358
SUPPL-7 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
11/14/2023 ESTRADIOL
ANDA #216524
ORIG-1 ESTRADIOL PADAGIS ISRAEL Approval
11/14/2023 ANGIOTENSIN II
ANDA #216966
ORIG-1 ANGIOTENSIN II GLAND PHARMA LTD Tentative Approval
11/15/2023 FLONASE SENSIMIST ALLERGY RELIEF
NDA #022051
SUPPL-21 FLUTICASONE FUROATE HALEON US HOLDINGS Labeling Approval
11/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228
SUPPL-14 OMEPRAZOLE; SODIUM BICARBONATE AJANTA PHARMA LTD Labeling Approval
11/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228
SUPPL-19 OMEPRAZOLE; SODIUM BICARBONATE AJANTA PHARMA LTD Labeling Approval
11/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228
SUPPL-21 OMEPRAZOLE; SODIUM BICARBONATE AJANTA PHARMA LTD Labeling Approval
11/15/2023 FLONASE ALLERGY RELIEF
NDA #205434
SUPPL-15 FLUTICASONE PROPIONATE HALEON US HOLDINGS Labeling Approval
11/15/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209735
SUPPL-16 ESOMEPRAZOLE MAGNESIUM SUN PHARM Labeling Approval
11/15/2023 IMCIVREE
NDA #213793
SUPPL-5 SETMELANOTIDE ACETATE RHYTHM Labeling Approval
11/15/2023 DEFENCATH
NDA #214520
ORIG-1 HEPARIN SODIUM; TAUROLIDINE CORMEDIX Type 1 - New Molecular Entity and Type 4 - New Combination Approval
11/15/2023 NALMEFENE HYDROCHLORIDE
ANDA #216007
ORIG-1 NALMEFENE HYDROCHLORIDE CHENGDU SHUODE Approval
11/15/2023 FLUOXETINE HYDROCHLORIDE
ANDA #216232
SUPPL-2 FLUOXETINE HYDROCHLORIDE MICRO LABS Labeling Approval
11/15/2023 AUGTYRO
NDA #218213
ORIG-1 REPOTRECTINIB BRISTOL Type 1 - New Molecular Entity Approval
11/16/2023 METHOTREXATE LPF
NDA #011719
SUPPL-138 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/16/2023 METHOTREXATE PRESERVATIVE FREE
NDA #011719
SUPPL-138 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/16/2023 METHOTREXATE SODIUM
NDA #011719
SUPPL-138 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/16/2023 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719
SUPPL-138 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/16/2023 COPAXONE
NDA #020622
SUPPL-116 GLATIRAMER ACETATE TEVA PHARMS USA Labeling Approval
11/16/2023 THYRO-TABS
NDA #021116
SUPPL-27 LEVOTHYROXINE SODIUM ALVOGEN Labeling Approval
11/16/2023 GILENYA
NDA #022527
SUPPL-39 FINGOLIMOD HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
11/16/2023 LEVETIRACETAM
ANDA #090876
SUPPL-8 LEVETIRACETAM FRESENIUS KABI USA Labeling Approval
11/16/2023 PANTOPRAZOLE SODIUM
ANDA #090970
SUPPL-31 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
11/16/2023 SIMPONI
BLA #125289
SUPPL-153 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
11/16/2023 KEYTRUDA
BLA #125514
SUPPL-143 PEMBROLIZUMAB MERCK SHARP DOHME Approval
11/16/2023 LEVETIRACETAM
ANDA #200475
SUPPL-11 LEVETIRACETAM AUROBINDO PHARMA USA Labeling Approval
11/16/2023 LEVETIRACETAM
ANDA #202167
SUPPL-9 LEVETIRACETAM DEXCEL Labeling Approval
11/16/2023 LEVETIRACETAM
ANDA #203059
SUPPL-27 LEVETIRACETAM SUN PHARM Labeling Approval
11/16/2023 XTANDI
NDA #203415
SUPPL-22 ENZALUTAMIDE ASTELLAS Efficacy Approval
11/16/2023 JAIMIESS
ANDA #203770
SUPPL-4 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
11/16/2023 JAIMIESS
ANDA #203770
SUPPL-5 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
11/16/2023 LINEZOLID
ANDA #204764
SUPPL-4 LINEZOLID FRESENIUS KABI USA Labeling Approval
11/16/2023 LINEZOLID
ANDA #204764
SUPPL-5 LINEZOLID FRESENIUS KABI USA Labeling Approval
11/16/2023 LINEZOLID
ANDA #204764
SUPPL-8 LINEZOLID FRESENIUS KABI USA Labeling Approval
11/16/2023 TIROSINT-SOL
NDA #206977
SUPPL-10 LEVOTHYROXINE SODIUM IBSA Labeling Approval
11/16/2023 TIROSINT-SOL
NDA #206977
SUPPL-12 LEVOTHYROXINE SODIUM IBSA Labeling Approval
11/16/2023 TERIPARATIDE
ANDA #208569
ORIG-1 TERIPARATIDE TEVA PHARMS USA Approval
11/16/2023 ARMONAIR DIGIHALER
NDA #208798
SUPPL-16 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
11/16/2023 ARMONAIR RESPICLICK
NDA #208798
SUPPL-16 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
11/16/2023 AIRDUO DIGIHALER
NDA #208799
SUPPL-26 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE TEVA PHARM Labeling Approval
11/16/2023 AIRDUO RESPICLICK
NDA #208799
SUPPL-26 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE TEVA PHARM Labeling Approval
11/16/2023 TERIPARATIDE
ANDA #211097
ORIG-1 TERIPARATIDE APOTEX Approval
11/16/2023 ESTRADIOL
ANDA #211293
SUPPL-9 ESTRADIOL AMNEAL Labeling Approval
11/16/2023 TAZVERIK
NDA #211723
SUPPL-4 TAZEMETOSTAT HYDROBROMIDE EPIZYME INC Labeling Approval
11/16/2023 TURALIO
NDA #211810
SUPPL-12 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC Labeling Approval
11/16/2023 BONSITY
NDA #211939
SUPPL-4 TERIPARATIDE ALVOGEN Efficacy Approval
11/16/2023 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #212418
SUPPL-1 ACETAMINOPHEN; CODEINE PHOSPHATE ELITE LABS INC Labeling Approval
11/16/2023 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #212418
SUPPL-2 ACETAMINOPHEN; CODEINE PHOSPHATE ELITE LABS INC Labeling Approval
11/16/2023 XTANDI
NDA #213674
SUPPL-10 ENZALUTAMIDE ASTELLAS Efficacy Approval
11/16/2023 GANIRELIX ACETATE
ANDA #216075
ORIG-1 GANIRELIX ACETATE LUPIN LTD Approval
11/16/2023 TRUQAP
NDA #218197
ORIG-1 CAPIVASERTIB ASTRAZENECA Type 1 - New Molecular Entity Approval
11/16/2023 RYZNEUTA
BLA #761134
ORIG-1 EFBEMALENOGRASTIM ALFA-VUXW EVIVE BIOTECHNOLOGY Approval
11/16/2023 IDACIO
BLA #761255
SUPPL-4 ADALIMUMAB-AACF FRESENIUS KABI USA Approval
11/16/2023 TECVAYLI
BLA #761291
SUPPL-5 TECLISTAMAB-CQYV JANSSEN BIOTECH Approval
11/16/2023 TALVEY
BLA #761342
SUPPL-1 TALQUETAMAB-TGVS JANSSEN BIOTECH Approval
11/17/2023 MONISTAT 3 COMBINATION PACK
NDA #020670
SUPPL-41 MICONAZOLE NITRATE MEDTECH PRODUCTS Labeling Approval
11/17/2023 TRELSTAR
NDA #020715
SUPPL-47 TRIPTORELIN PAMOATE VERITY Labeling Approval
11/17/2023 TRELSTAR
NDA #021288
SUPPL-42 TRIPTORELIN PAMOATE VERITY Labeling Approval
11/17/2023 TRELSTAR
NDA #022437
SUPPL-22 TRIPTORELIN PAMOATE VERITY Labeling Approval
11/17/2023 PRADAXA
NDA #022512
SUPPL-47 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
11/17/2023 TEMAZEPAM
ANDA #203482
SUPPL-16 TEMAZEPAM AMNEAL PHARMS Labeling Approval
11/17/2023 DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
ANDA #215049
ORIG-1 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM ANNORA PHARMA Approval
11/17/2023 TOPIRAMATE
ANDA #217231
ORIG-1 TOPIRAMATE DR REDDYS Approval
11/18/2023 TEMAZEPAM
ANDA #071620
SUPPL-45 TEMAZEPAM ACTAVIS ELIZABETH Labeling Approval
11/18/2023 ALPRAZOLAM
ANDA #074312
SUPPL-17 ALPRAZOLAM HIKMA Labeling Approval
11/18/2023 TRAMADOL HYDROCHLORIDE
ANDA #076003
SUPPL-55 TRAMADOL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
11/18/2023 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732
SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM HIKMA Labeling Approval
11/18/2023 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490
SUPPL-10 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
11/18/2023 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490
SUPPL-13 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
11/19/2023 DARUNAVIR
ANDA #202073
SUPPL-1 DARUNAVIR LUPIN LTD Labeling Approval
11/19/2023 DARUNAVIR
ANDA #202073
SUPPL-2 DARUNAVIR LUPIN LTD Labeling Approval
11/20/2023 VIOKACE
BLA #022542
SUPPL-10 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIOKACE Approval
11/20/2023 DICLOFENAC POTASSIUM
ANDA #075582
SUPPL-7 DICLOFENAC POTASSIUM CHARTWELL RX Labeling Approval
11/20/2023 CITALOPRAM HYDROBROMIDE
ANDA #077654
SUPPL-4 CITALOPRAM HYDROBROMIDE GLENMARK PHARMS LTD Labeling Approval
11/20/2023 TALTZ
BLA #125521
SUPPL-31 IXEKIZUMAB ELI LILLY AND CO Tentative Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #205606
SUPPL-16 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
11/20/2023 PITAVASTATIN CALCIUM
ANDA #206029
ORIG-1 PITAVASTATIN CALCIUM LUPIN LTD Approval
11/20/2023 PITAVASTATIN CALCIUM
ANDA #206029
SUPPL-1 PITAVASTATIN CALCIUM LUPIN LTD Approval
11/20/2023 PITAVASTATIN CALCIUM
ANDA #206029
SUPPL-2 PITAVASTATIN CALCIUM LUPIN LTD Approval
11/20/2023 PITAVASTATIN CALCIUM
ANDA #206029
SUPPL-3 PITAVASTATIN CALCIUM LUPIN LTD Approval
11/20/2023 GABAPENTIN
ANDA #208928
ORIG-1 GABAPENTIN IPCA LABS LTD Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209339
SUPPL-13 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA Manufacturing (CMC) Approval
11/20/2023 FLUOXETINE HYDROCHLORIDE
ANDA #209419
SUPPL-2 FLUOXETINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
11/20/2023 FLUOXETINE HYDROCHLORIDE
ANDA #209419
SUPPL-3 FLUOXETINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209495
SUPPL-1 ESOMEPRAZOLE MAGNESIUM GLENMARK SPECLT Labeling Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209495
SUPPL-2 ESOMEPRAZOLE MAGNESIUM GLENMARK SPECLT Labeling Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209495
SUPPL-4 ESOMEPRAZOLE MAGNESIUM GLENMARK SPECLT Labeling Approval
11/20/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209495
SUPPL-7 ESOMEPRAZOLE MAGNESIUM GLENMARK SPECLT Labeling Approval
11/20/2023 CYCLOPHOSPHAMIDE
NDA #210735
SUPPL-2 CYCLOPHOSPHAMIDE EUGIA PHARMA SPECLTS Labeling Approval
11/20/2023 ESTRADIOL
ANDA #211396
SUPPL-4 ESTRADIOL AMNEAL Labeling Approval
11/20/2023 DAPAGLIFLOZIN
ANDA #211531
ORIG-1 DAPAGLIFLOZIN LUPIN LTD Tentative Approval
11/20/2023 BREXPIPRAZOLE
ANDA #213669
ORIG-1 BREXPIPRAZOLE HETERO LABS LTD V Approval
11/20/2023 ASTEPRO ALLERGY
NDA #213872
SUPPL-4 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
11/20/2023 CHILDREN'S ASTEPRO ALLERGY
NDA #213872
SUPPL-4 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
11/20/2023 LEVETIRACETAM
ANDA #214673
ORIG-1 LEVETIRACETAM STRIDES PHARMA Approval
11/20/2023 IBUPROFEN AND FAMOTIDINE
ANDA #216814
SUPPL-1 FAMOTIDINE; IBUPROFEN ASCENT PHARMS INC Manufacturing (CMC) Approval
11/20/2023 PROBENECID
ANDA #217020
ORIG-1 PROBENECID RISING Approval
11/20/2023 PROBENECID
ANDA #217020
SUPPL-1 PROBENECID RISING Approval
11/20/2023 BUPIVACAINE HYDROCHLORIDE
ANDA #217792
ORIG-1 BUPIVACAINE HYDROCHLORIDE SOMERSET Approval
11/21/2023 ANECTINE
NDA #008453
SUPPL-41 SUCCINYLCHOLINE CHLORIDE SANDOZ Labeling Approval
11/21/2023 GONAL-F
BLA #020378
SUPPL-84 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/21/2023 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779
SUPPL-28 ACETAMINOPHEN; CODEINE PHOSPHATE AMNEAL PHARMS NY Labeling Approval
11/21/2023 FLUOXETINE HYDROCHLORIDE
ANDA #075465
SUPPL-21 FLUOXETINE HYDROCHLORIDE MARKSANS PHARMA Labeling Approval
11/21/2023 GRANIX
BLA #125294
SUPPL-58 TBO-FILGRASTIM SICOR BIOTECH Approval
11/21/2023 COSENTYX
BLA #125504
SUPPL-66 SECUKINUMAB NOVARTIS PHARMS CORP Approval
11/21/2023 LEVETIRACETAM
ANDA #201157
SUPPL-11 LEVETIRACETAM PHARM ASSOC Labeling Approval
11/21/2023 BIVALIRUDIN
ANDA #201577
SUPPL-3 BIVALIRUDIN DR REDDYS Labeling Approval
11/21/2023 MONTELUKAST SODIUM
ANDA #202717
SUPPL-20 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
11/21/2023 TRIMETHOBENZAMIDE HYDROCHLORIDE
ANDA #205950
ORIG-1 TRIMETHOBENZAMIDE HYDROCHLORIDE AVET LIFESCIENCES Approval
11/21/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #209193
SUPPL-5 VENLAFAXINE HYDROCHLORIDE DEXCEL Labeling Approval
11/21/2023 APIXABAN
ANDA #210066
ORIG-1 APIXABAN HETERO LABS LTD V Approval
11/21/2023 TOBRAMYCIN
ANDA #210915
SUPPL-1 TOBRAMYCIN TEVA PHARMS USA Labeling Approval
11/21/2023 LINEZOLID
ANDA #211813
SUPPL-2 LINEZOLID HETERO LABS Labeling Approval
11/21/2023 FLUVOXAMINE MALEATE
ANDA #212182
SUPPL-6 FLUVOXAMINE MALEATE BIONPHARMA Labeling Approval
11/21/2023 ACYCLOVIR
ANDA #212361
ORIG-1 ACYCLOVIR ALEMBIC Approval
11/21/2023 ORLADEYO
NDA #214094
SUPPL-2 BEROTRALSTAT HYDROCHLORIDE BIOCRYST Labeling Approval
11/21/2023 PACLITAXEL
NDA #216338
SUPPL-1 PACLITAXEL TEVA PHARMS INC Efficacy Approval
11/21/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #217390
SUPPL-2 VENLAFAXINE HYDROCHLORIDE GRANULES Labeling Approval
11/21/2023 PROGESTERONE
ANDA #217707
ORIG-1 PROGESTERONE ACCORD HLTHCARE Approval
11/21/2023 PROGESTERONE
ANDA #217707
SUPPL-1 PROGESTERONE ACCORD HLTHCARE Approval
11/21/2023 COSENTYX
BLA #761349
SUPPL-4 SECUKINUMAB NOVARTIS PHARMS CORP Approval
11/22/2023 METROGEL
NDA #021789
SUPPL-13 METRONIDAZOLE GALDERMA LABS LP Labeling Approval
11/22/2023 DIAZEPAM
ANDA #070464
SUPPL-8 DIAZEPAM NUVO PHARM Manufacturing (CMC) Approval
11/22/2023 METOPROLOL TARTRATE
ANDA #077739
SUPPL-30 METOPROLOL TARTRATE AUROBINDO PHARMA Labeling Approval
11/22/2023 DIVALPROEX SODIUM
ANDA #078853
SUPPL-15 DIVALPROEX SODIUM ORBION PHARMS Labeling Approval
11/22/2023 DIVALPROEX SODIUM
ANDA #078853
SUPPL-17 DIVALPROEX SODIUM ORBION PHARMS Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079145
SUPPL-7 ROSUVASTATIN CALCIUM APOTEX Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079145
SUPPL-8 ROSUVASTATIN CALCIUM APOTEX Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079145
SUPPL-9 ROSUVASTATIN CALCIUM APOTEX Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079170
SUPPL-12 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079170
SUPPL-13 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079170
SUPPL-16 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079170
SUPPL-19 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079170
SUPPL-21 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #079171
SUPPL-14 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
11/22/2023 METRONIDAZOLE
ANDA #203458
SUPPL-19 METRONIDAZOLE UNICHEM Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #205587
SUPPL-4 ROSUVASTATIN CALCIUM LUPIN Labeling Approval
11/22/2023 BROMFENAC SODIUM
ANDA #206027
ORIG-1 BROMFENAC SODIUM LUPIN LTD Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-15 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-17 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-22 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207408
SUPPL-24 ROSUVASTATIN CALCIUM CHANGZHOU PHARM Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207752
SUPPL-10 ROSUVASTATIN CALCIUM BIOCON PHARMA Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207752
SUPPL-13 ROSUVASTATIN CALCIUM BIOCON PHARMA Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207752
SUPPL-17 ROSUVASTATIN CALCIUM BIOCON PHARMA Labeling Approval
11/22/2023 ROSUVASTATIN CALCIUM
ANDA #207752
SUPPL-19 ROSUVASTATIN CALCIUM BIOCON PHARMA Labeling Approval
11/22/2023 CANAGLIFLOZIN
ANDA #211103
ORIG-1 CANAGLIFLOZIN LUPIN Tentative Approval
11/22/2023 PODOFILOX
ANDA #211871
ORIG-1 PODOFILOX PADAGIS US Approval
11/22/2023 PODOFILOX
ANDA #211871
SUPPL-1 PODOFILOX PADAGIS US Approval
11/22/2023 DEFERIPRONE
ANDA #213239
SUPPL-6 DEFERIPRONE HIKMA Labeling Approval
11/22/2023 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
ANDA #215469
ORIG-1 MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE STRIDES PHARMA Approval
11/22/2023 BRIMONIDINE TARTRATE
ANDA #217846
ORIG-1 BRIMONIDINE TARTRATE MICRO LABS Approval
11/24/2023 CARFILZOMIB
ANDA #209425
SUPPL-1 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #209425
SUPPL-2 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #209425
SUPPL-3 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #209425
SUPPL-4 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #211185
SUPPL-1 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #211185
SUPPL-2 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #211185
SUPPL-4 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 CARFILZOMIB
ANDA #211185
SUPPL-5 CARFILZOMIB APOTEX Labeling Approval
11/24/2023 OSELTAMIVIR PHOSPHATE
ANDA #218009
ORIG-1 OSELTAMIVIR PHOSPHATE HAINAN POLY Approval
11/24/2023 OSELTAMIVIR PHOSPHATE
ANDA #218009
SUPPL-1 OSELTAMIVIR PHOSPHATE HAINAN POLY Approval
11/27/2023 METHOTREXATE LPF
NDA #011719
SUPPL-136 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
11/27/2023 METHOTREXATE PRESERVATIVE FREE
NDA #011719
SUPPL-136 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
11/27/2023 METHOTREXATE SODIUM
NDA #011719
SUPPL-136 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
11/27/2023 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719
SUPPL-136 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
11/27/2023 TRI-SPRINTEC
ANDA #075808
SUPPL-43 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
11/27/2023 TRI-SPRINTEC
ANDA #075808
SUPPL-45 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
11/27/2023 FLUVOXAMINE MALEATE
ANDA #075902
SUPPL-29 FLUVOXAMINE MALEATE APOTEX Labeling Approval
11/27/2023 METRONIDAZOLE
ANDA #076522
SUPPL-11 METRONIDAZOLE CHARTWELL RX Labeling Approval
11/27/2023 LEVETIRACETAM
ANDA #090981
SUPPL-14 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
11/27/2023 LEVETIRACETAM
ANDA #091668
SUPPL-2 LEVETIRACETAM SANDOZ Labeling Approval
11/27/2023 MONTELUKAST SODIUM
ANDA #201581
SUPPL-10 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/27/2023 MONTELUKAST SODIUM
ANDA #201582
SUPPL-18 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/27/2023 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897
SUPPL-6 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
11/27/2023 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897
SUPPL-8 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
11/27/2023 LINEZOLID
ANDA #206454
SUPPL-2 LINEZOLID HIKMA Labeling Approval
11/27/2023 TRAMADOL HYDROCHLORIDE
ANDA #208708
SUPPL-13 TRAMADOL HYDROCHLORIDE RUBICON Manufacturing (CMC) Approval
11/27/2023 MESALAMINE
ANDA #208953
SUPPL-6 MESALAMINE ZYDUS PHARMS Labeling Approval
11/27/2023 MESALAMINE
ANDA #208954
SUPPL-3 MESALAMINE ZYDUS PHARMS Labeling Approval
11/27/2023 ZAFIRLUKAST
ANDA #213163
ORIG-1 ZAFIRLUKAST AUROBINDO PHARMA Approval
11/27/2023 OGSIVEO
NDA #217677
ORIG-1 NIROGACESTAT HYDROBROMIDE SPRINGWORKS Type 1 - New Molecular Entity Approval
11/28/2023 DROXIA
NDA #016295
SUPPL-58 HYDROXYUREA CHEPLAPHARM Labeling Approval
11/28/2023 HYDREA
NDA #016295
SUPPL-58 HYDROXYUREA CHEPLAPHARM Labeling Approval
11/28/2023 LESCOL XL
NDA #021192
SUPPL-29 FLUVASTATIN SODIUM SANDOZ Labeling Approval
11/28/2023 EXPAREL
NDA #022496
SUPPL-51 BUPIVACAINE PACIRA PHARMS INC Labeling Approval
11/28/2023 AZASAN
ANDA #075252
SUPPL-23 AZATHIOPRINE AAIPHARMA LLC Labeling Approval
11/28/2023 DEFEROXAMINE MESYLATE
ANDA #078718
SUPPL-9 DEFEROXAMINE MESYLATE FRESENIUS KABI USA Labeling Approval
11/28/2023 FOSPHENYTOIN SODIUM
ANDA #078736
SUPPL-12 FOSPHENYTOIN SODIUM MYLAN LABS LTD Labeling Approval
11/28/2023 FOSPHENYTOIN SODIUM
ANDA #078736
SUPPL-14 FOSPHENYTOIN SODIUM MYLAN LABS LTD Labeling Approval
11/28/2023 OXALIPLATIN
ANDA #078817
SUPPL-27 OXALIPLATIN SANDOZ Labeling Approval
11/28/2023 MYCOPHENOLIC SODIUM
ANDA #091558
SUPPL-14 MYCOPHENOLIC SODIUM APOTEX INC Labeling Approval
11/28/2023 MYCOPHENOLIC SODIUM
ANDA #091558
SUPPL-17 MYCOPHENOLIC SODIUM APOTEX INC Labeling Approval
11/28/2023 MYCOPHENOLIC SODIUM
ANDA #091558
SUPPL-19 MYCOPHENOLIC SODIUM APOTEX INC Labeling Approval
11/28/2023 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #201072
SUPPL-8 DEXMEDETOMIDINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/28/2023 TIGECYCLINE
ANDA #205722
SUPPL-3 TIGECYCLINE XELLIA PHARMS APS Labeling Approval
11/28/2023 TIGECYCLINE
ANDA #205722
SUPPL-4 TIGECYCLINE XELLIA PHARMS APS Labeling Approval
11/28/2023 FEBUXOSTAT
ANDA #206266
SUPPL-2 FEBUXOSTAT PRINSTON INC Labeling Approval
11/28/2023 FEBUXOSTAT
ANDA #206266
SUPPL-3 FEBUXOSTAT PRINSTON INC Labeling Approval
11/28/2023 DARUNAVIR
ANDA #206288
ORIG-1 DARUNAVIR CIPLA Approval
11/28/2023 DARUNAVIR
ANDA #206288
ORIG-2 DARUNAVIR CIPLA Tentative Approval
11/28/2023 ABIRATERONE ACETATE
ANDA #208380
SUPPL-4 ABIRATERONE ACETATE WOCKHARDT BIO AG Labeling Approval
11/28/2023 SIKLOS
NDA #208843
SUPPL-4 HYDROXYUREA THERAVIA Labeling Approval
11/28/2023 BIMATOPROST
ANDA #210515
SUPPL-2 BIMATOPROST ALEMBIC Labeling Approval
11/28/2023 BIMATOPROST
ANDA #210515
SUPPL-3 BIMATOPROST ALEMBIC Labeling Approval
11/28/2023 DARUNAVIR
ANDA #210677
ORIG-1 DARUNAVIR AUROBINDO PHARMA LTD Approval
11/28/2023 ICATIBANT ACETATE
ANDA #211021
SUPPL-6 ICATIBANT ACETATE JIANGSU HANSOH PHARM Labeling Approval
11/28/2023 URSODIOL
ANDA #211145
SUPPL-1 URSODIOL ZYDUS LIFESCIENCES Labeling Approval
11/28/2023 URSODIOL
ANDA #211145
SUPPL-2 URSODIOL ZYDUS LIFESCIENCES Labeling Approval
11/28/2023 DARUNAVIR
ANDA #211578
ORIG-1 DARUNAVIR DR REDDYS Approval
11/28/2023 BREXPIPRAZOLE
ANDA #213782
ORIG-1 BREXPIPRAZOLE ALKEM LABS LTD Approval
11/28/2023 TRIAZOLAM
ANDA #214219
SUPPL-5 TRIAZOLAM NOVAST LABS Labeling Approval
11/28/2023 DARUNAVIR
ANDA #215389
ORIG-1 DARUNAVIR MSN Approval
11/28/2023 RYZUMVI
NDA #217064
SUPPL-1 PHENTOLAMINE MESYLATE FAMYGEN LIFE SCI Labeling Approval
11/28/2023 AZILSARTAN MEDOXOMIL; CHLORTHALIDONE
ANDA #217490
ORIG-1 AZILSARTAN MEDOXOMIL;CHLORTHALIDONE ALKEM LABS LTD Tentative Approval
11/28/2023 SILDENAFIL CITRATE
ANDA #218045
ORIG-1 SILDENAFIL CITRATE CADILA PHARMS LTD Approval
11/29/2023 VOLTAREN ARTHRITIS PAIN
NDA #022122
SUPPL-25 DICLOFENAC SODIUM HALEON US HOLDINGS Labeling Approval
11/29/2023 MIRTAZAPINE
ANDA #076176
SUPPL-10 MIRTAZAPINE MYLAN PHARMS INC Labeling Approval
11/29/2023 OXALIPLATIN
ANDA #078803
SUPPL-7 OXALIPLATIN ACTAVIS TOTOWA Labeling Approval
11/29/2023 NEVIRAPINE
ANDA #206448
SUPPL-6 NEVIRAPINE CIPLA Labeling Approval
11/29/2023 CLARISCAN
ANDA #210016
SUPPL-7 GADOTERATE MEGLUMINE GE HEALTHCARE Labeling Approval
11/29/2023 FEBUXOSTAT
ANDA #210292
SUPPL-5 FEBUXOSTAT INDOCO Labeling Approval
11/29/2023 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #210374
ORIG-1 AMOXICILLIN; CLAVULANATE POTASSIUM DEVA HOLDING AS Approval
11/29/2023 HYDROXYCHLOROQUINE SULFATE
ANDA #210441
SUPPL-13 HYDROXYCHLOROQUINE SULFATE APPCO Labeling Approval
11/29/2023 CLOBETASOL PROPIONATE
ANDA #210809
SUPPL-1 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Labeling Approval
11/29/2023 CLOBETASOL PROPIONATE
ANDA #210809
SUPPL-2 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Labeling Approval
11/29/2023 CLOBETASOL PROPIONATE
ANDA #210809
SUPPL-4 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Labeling Approval
11/29/2023 BRINZOLAMIDE; BRIMONIDINE TARTRATE
ANDA #212137
ORIG-1 BRINZOLAMIDE;BRIMONIDINE TARTRATE PERRIGO PHARMA INTERNATIONAL DAC Tentative Approval
11/29/2023 IVABRADINE HYDROCHLORIDE
ANDA #213442
ORIG-1 IVABRADINE HYDROCHLORIDE ZYDUS PHARMS Approval
11/29/2023 PANTOPRAZOLE SODIUM
ANDA #213725
SUPPL-6 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
11/29/2023 LOTEPREDNOL ETABONATE
ANDA #213956
ORIG-1 LOTEPREDNOL ETABONATE HIKMA Approval
11/29/2023 FOSCARNET SODIUM
ANDA #213987
ORIG-1 FOSCARNET SODIUM BEIJING Approval
11/29/2023 AZELASTINE HYDROCHLORIDE
ANDA #216561
ORIG-1 AZELASTINE HYDROCHLORIDE AUROBINDO PHARMA LTD Tentative Approval
11/29/2023 BUDESONIDE
ANDA #216667
ORIG-1 BUDESONIDE EUGIA PHARMA Approval
11/29/2023 ALVAIZ
NDA #216774
ORIG-1 ELTROMBOPAG CHOLINE TEVA PHARMS INC Type 2 - New Active Ingredient Approval
11/29/2023 MYCOPHENOLIC SODIUM
ANDA #217031
ORIG-1 MYCOPHENOLIC SODIUM BIOCON PHARMA Approval
11/29/2023 ASPARLAS
BLA #761102
SUPPL-13 CALASPARGASE PEGOL-MKNL SERVIER PHARMA LLC Approval
11/29/2023 SEMGLEE
BLA #761201
SUPPL-8 INSULIN GLARGINE-YFGN MYLAN PHARMS INC Approval
11/30/2023 SODIUM PHOSPHATES IN PLASTIC CONTAINER
NDA #018892
SUPPL-38 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS HOSPIRA Manufacturing (CMC) Approval
11/30/2023 CONTRAVE
NDA #200063
SUPPL-21 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Labeling Approval
11/30/2023 LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
NDA #205054
SUPPL-5 LEUPROLIDE ACETATE INVAGEN PHARMS Labeling Approval
11/30/2023 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #211610
SUPPL-1 ACETAMINOPHEN; CODEINE PHOSPHATE WES PHARMA INC Labeling Approval
11/30/2023 TRAMADOL HYDROCHLORIDE
ANDA #211825
SUPPL-5 TRAMADOL HYDROCHLORIDE UNICHEM Labeling Approval
11/30/2023 TRAMADOL HYDROCHLORIDE
ANDA #211825
SUPPL-8 TRAMADOL HYDROCHLORIDE UNICHEM Labeling Approval
11/30/2023 TRAMADOL HYDROCHLORIDE
ANDA #211825
SUPPL-12 TRAMADOL HYDROCHLORIDE UNICHEM Labeling Approval
11/30/2023 SYFOVRE
NDA #217171
SUPPL-1 PEGCETACOPLAN APELLIS PHARMS Labeling Approval
11/30/2023 YUFLYMA
BLA #761219
SUPPL-2 ADALIMUMAB-AATY CELLTRION Approval
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