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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 2022

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on June 22, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/2022 PROVOCHOLINE
NDA #019193		 SUPPL-26 METHACHOLINE CHLORIDE METHAPHARM Manufacturing (CMC) Approval
03/01/2022 ULTANE
NDA #020478		 SUPPL-23 SEVOFLURANE ABBVIE Labeling Approval
03/01/2022 ULTANE
NDA #020478		 SUPPL-24 SEVOFLURANE ABBVIE Labeling Approval
03/01/2022 ULTANE
NDA #020478		 SUPPL-27 SEVOFLURANE ABBVIE Labeling Approval
03/01/2022 ULTANE
NDA #020478		 SUPPL-28 SEVOFLURANE ABBVIE Labeling Approval
03/01/2022 PREVACID 24 HR
NDA #022327		 SUPPL-29 LANSOPRAZOLE PERRIGO PHARMA INTL Labeling Approval
03/01/2022 XARELTO
NDA #022406		 SUPPL-39 RIVAROXABAN JANSSEN PHARMS Labeling Approval
03/01/2022 KURVELO
ANDA #091408		 SUPPL-13 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Labeling Approval
03/01/2022 XARELTO
NDA #202439		 SUPPL-38 RIVAROXABAN JANSSEN PHARMS Labeling Approval
03/01/2022 ONDANSETRON HYDROCHLORIDE
ANDA #202599		 SUPPL-9 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
03/01/2022 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202600		 SUPPL-11 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
03/01/2022 MAYZENT
NDA #209884		 SUPPL-7 SIPONIMOD NOVARTIS Efficacy Approval
03/01/2022 DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
ANDA #212472		 ORIG-1 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE ACTAVIS LABS FL INC Approval
03/01/2022 LENVATINIB
ANDA #213092		 ORIG-1 LENVATINIB MESYLATE SUN PHARM INDS INC Tentative Approval
03/02/2022 ALEVE-D SINUS & COLD
NDA #021076		 SUPPL-17 NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE BAYER Labeling Approval
03/02/2022 ORAQIX
NDA #021451		 SUPPL-13 LIDOCAINE; PRILOCAINE DENTSPLY PHARM Labeling Approval
03/02/2022 VENTAVIS
NDA #021779		 SUPPL-21 ILOPROST ACTELION Labeling Approval
03/02/2022 STEGLUJAN
NDA #209805		 SUPPL-10 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
03/02/2022 SEGLUROMET
NDA #209806		 SUPPL-8 ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE MSD SUB MERCK Labeling Approval
03/02/2022 EFINACONAZOLE
ANDA #212169		 ORIG-1 EFINACONAZOLE LUPIN LTD Approval
03/02/2022 SITAGLIPTIN
ANDA #214054		 ORIG-1 SITAGLIPTIN INTAS PHARMS USA Tentative Approval
03/02/2022 ARFORMOTEROL TARTRATE
ANDA #214736		 ORIG-1 ARFORMOTEROL TARTRATE RITEDOSE CORP Approval
03/03/2022 DILANTIN-125
NDA #008762		 SUPPL-66 PHENYTOIN VIATRIS Labeling Approval
03/03/2022 DILANTIN-30
NDA #008762		 SUPPL-66 PHENYTOIN VIATRIS Labeling Approval
03/03/2022 TAZICEF
ANDA #064032		 SUPPL-14 CEFTAZIDIME HOSPIRA Labeling Approval
03/03/2022 TAZICEF
ANDA #064032		 SUPPL-16 CEFTAZIDIME HOSPIRA Labeling Approval
03/03/2022 TAZICEF
ANDA #064032		 SUPPL-20 CEFTAZIDIME HOSPIRA Labeling Approval
03/03/2022 TAZICEF
ANDA #064032		 SUPPL-25 CEFTAZIDIME HOSPIRA Labeling Approval
03/03/2022 LARIN 24 FE
ANDA #202994		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
03/03/2022 LARIN 24 FE
ANDA #202994		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
03/03/2022 NIACIN
ANDA #204934		 ORIG-1 NIACIN MACLEODS PHARMS LTD Approval
03/04/2022 OMNIPRED
NDA #017469		 SUPPL-47 PREDNISOLONE ACETATE SANDOZ Labeling Approval
03/04/2022 NICODERM CQ
NDA #020165		 SUPPL-47 NICOTINE CHATTEM SANOFI Labeling Approval
03/04/2022 PREVACID
NDA #020406		 SUPPL-94 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
03/04/2022 ACIPHEX
NDA #020973		 SUPPL-42 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
03/04/2022 PROTONIX
NDA #020987		 SUPPL-58 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
03/04/2022 PROTONIX IV
NDA #020988		 SUPPL-64 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
03/04/2022 NEXIUM
NDA #021153		 SUPPL-59 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/04/2022 PREVACID
NDA #021428		 SUPPL-41 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
03/04/2022 WELLBUTRIN XL
NDA #021515		 SUPPL-44 BUPROPION HYDROCHLORIDE BAUSCH Labeling Approval
03/04/2022 ZEGERID
NDA #021636		 SUPPL-24 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
03/04/2022 NEXIUM IV
NDA #021689		 SUPPL-37 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
03/04/2022 ZEGERID
NDA #021849		 SUPPL-19 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
03/04/2022 NEXIUM
NDA #021957		 SUPPL-26 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/04/2022 PROTONIX
NDA #022020		 SUPPL-21 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
03/04/2022 PRILOSEC
NDA #022056		 SUPPL-25 OMEPRAZOLE MAGNESIUM COVIS Labeling Approval
03/04/2022 NEXIUM
NDA #022101		 SUPPL-23 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/04/2022 APLENZIN
NDA #022108		 SUPPL-22 BUPROPION HYDROBROMIDE BAUSCH Labeling Approval
03/04/2022 DEXILANT
NDA #022287		 SUPPL-35 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
03/04/2022 VIMOVO
NDA #022511		 SUPPL-28 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
03/04/2022 OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
NDA #050824		 SUPPL-10 AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE CUMBERLAND Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075347		 SUPPL-29 OMEPRAZOLE ACTAVIS LABS FL INC Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075410		 SUPPL-66 OMEPRAZOLE LANNETT CO INC Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075576		 SUPPL-22 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075757		 SUPPL-54 OMEPRAZOLE SANDOZ Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075785		 SUPPL-12 OMEPRAZOLE IMPAX LABS Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #075876		 SUPPL-44 OMEPRAZOLE STRIDES PHARMA Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #076048		 SUPPL-28 OMEPRAZOLE APOTEX Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #076515		 SUPPL-35 OMEPRAZOLE SANDOZ Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #078490		 SUPPL-18 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
03/04/2022 ALTAVERA
ANDA #079102		 SUPPL-10 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #091352		 SUPPL-21 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
03/04/2022 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #091663		 SUPPL-8 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
03/04/2022 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #091663		 SUPPL-11 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #091672		 SUPPL-22 OMEPRAZOLE GLENMARK PHARMS LTD Labeling Approval
03/04/2022 OPDIVO
BLA #125554		 SUPPL-112 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-6 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-7 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
03/04/2022 ESOMEPRAZOLE STRONTIUM
NDA #202342		 SUPPL-7 ESOMEPRAZOLE STRONTIUM BELCHER Labeling Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #202588		 SUPPL-1 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE SANDOZ Labeling Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #202588		 SUPPL-4 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE SANDOZ Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #203270		 SUPPL-19 OMEPRAZOLE AUROBINDO PHARMA Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #203481		 SUPPL-6 OMEPRAZOLE BRECKENRIDGE Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #204012		 SUPPL-2 OMEPRAZOLE HETERO LABS LTD III Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #204661		 SUPPL-7 OMEPRAZOLE TEVA PHARMS USA Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #205070		 SUPPL-3 OMEPRAZOLE MYLAN Labeling Approval
03/04/2022 YOSPRALA
NDA #205103		 SUPPL-8 ASPIRIN; OMEPRAZOLE GENUS LIFESCIENCES Labeling Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006		 SUPPL-2 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE RISING Labeling Approval
03/04/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006		 SUPPL-3 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE RISING Labeling Approval
03/04/2022 QTERN
NDA #209091		 SUPPL-6 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
03/04/2022 PANTOPRAZOLE SODIUM
NDA #209463		 SUPPL-15 PANTOPRAZOLE SODIUM HIKMA Labeling Approval
03/04/2022 OMEPRAZOLE
ANDA #212977		 SUPPL-4 OMEPRAZOLE XIROMED Labeling Approval
03/04/2022 TALICIA
NDA #213004		 SUPPL-7 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN REDHILL Labeling Approval
03/04/2022 PALBOCICLIB
ANDA #213152		 ORIG-1 PALBOCICLIB AIZANT DRUG RESEARCH SOLUTIONS PVT LTD Tentative Approval
03/04/2022 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #214186		 ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE ALEMBIC Approval
03/04/2022 PRADAXA
NDA #214358		 SUPPL-2 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
03/04/2022 DICLOFENAC POTASSIUM
ANDA #215375		 ORIG-1 DICLOFENAC POTASSIUM ANNORA PHARMA Approval
03/04/2022 DARZALEX
BLA #761036		 SUPPL-41 DARATUMUMAB JANSSEN BIOTECH Approval
03/04/2022 AIMOVIG
BLA #761077		 SUPPL-14 ERENUMAB-AOOE AMGEN INC Approval
03/07/2022 ZOCOR
NDA #019766		 SUPPL-99 SIMVASTATIN ORGANON Labeling Approval
03/07/2022 LEVORA 0.15/30-28
ANDA #073594		 SUPPL-28 ETHINYL ESTRADIOL; LEVONORGESTREL DR REDDYS LABS SA Labeling Approval
03/07/2022 LEVORA 0.15/30-28
ANDA #073594		 SUPPL-30 ETHINYL ESTRADIOL; LEVONORGESTREL DR REDDYS LABS SA Labeling Approval
03/07/2022 ALLOPURINOL
ANDA #214443		 ORIG-1 ALLOPURINOL HARMAN FINOCHEM Approval
03/08/2022 LUMIGAN
NDA #021275		 SUPPL-29 BIMATOPROST ABBVIE Labeling Approval
03/08/2022 LUMIGAN
NDA #022184		 SUPPL-9 BIMATOPROST ABBVIE Labeling Approval
03/08/2022 QSYMIA
NDA #022580		 SUPPL-20 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC REMS Approval
03/08/2022 HYDROXYCHLOROQUINE SULFATE
ANDA #040081		 SUPPL-32 HYDROXYCHLOROQUINE SULFATE TEVA PHARMS Labeling Approval
03/08/2022 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-32 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
03/08/2022 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-32 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
03/08/2022 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-32 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
03/08/2022 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-30 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
03/08/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
ANDA #070030		 SUPPL-40 SULFAMETHOXAZOLE; TRIMETHOPRIM HERITAGE PHARMA AVET Labeling Approval
03/08/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
ANDA #070030		 SUPPL-41 SULFAMETHOXAZOLE; TRIMETHOPRIM HERITAGE PHARMA AVET Labeling Approval
03/08/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
ANDA #070037		 SUPPL-39 SULFAMETHOXAZOLE; TRIMETHOPRIM HERITAGE PHARMA AVET Labeling Approval
03/08/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
ANDA #070037		 SUPPL-40 SULFAMETHOXAZOLE; TRIMETHOPRIM HERITAGE PHARMA AVET Labeling Approval
03/08/2022 OXALIPLATIN
ANDA #091358		 SUPPL-9 OXALIPLATIN MYLAN LABS LTD Labeling Approval
03/08/2022 LETROZOLE
ANDA #201804		 SUPPL-2 LETROZOLE INDICUS PHARMA Labeling Approval
03/08/2022 MYCOPHENOLATE MOFETIL
ANDA #203005		 SUPPL-10 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
03/08/2022 LEVETIRACETAM
ANDA #203308		 SUPPL-8 LEVETIRACETAM MYLAN LABS LTD Labeling Approval
03/08/2022 DUTASTERIDE
ANDA #204292		 SUPPL-3 DUTASTERIDE APOTEX Labeling Approval
03/08/2022 NITROGLYCERIN
ANDA #210153		 ORIG-1 NITROGLYCERIN ZYDUS PHARMS Approval
03/08/2022 PREGABALIN
ANDA #212988		 ORIG-1 PREGABALIN ESKAYEF Approval
03/09/2022 DIFLUCAN
NDA #019949		 SUPPL-71 FLUCONAZOLE PFIZER Labeling Approval
03/09/2022 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-70 FLUCONAZOLE PFIZER Labeling Approval
03/09/2022 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-70 FLUCONAZOLE PFIZER Labeling Approval
03/09/2022 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-70 FLUCONAZOLE PFIZER Labeling Approval
03/09/2022 DIFLUCAN
NDA #020090		 SUPPL-52 FLUCONAZOLE PFIZER Labeling Approval
03/09/2022 MYOVIEW
NDA #020372		 SUPPL-31 TECHNETIUM TC-99M TETROFOSMIN KIT GE HEALTHCARE Labeling Approval
03/09/2022 MYOVIEW 30ML
NDA #020372		 SUPPL-31 TECHNETIUM TC-99M TETROFOSMIN KIT GE HEALTHCARE Labeling Approval
03/09/2022 LEVORA 0.15/30-21
ANDA #073592		 SUPPL-21 ETHINYL ESTRADIOL; LEVONORGESTREL WATSON LABS Labeling Approval
03/09/2022 PORTIA-21
ANDA #075866		 SUPPL-31 ETHINYL ESTRADIOL; LEVONORGESTREL BARR Labeling Approval
03/09/2022 PORTIA-28
ANDA #075866		 SUPPL-31 ETHINYL ESTRADIOL; LEVONORGESTREL BARR Labeling Approval
03/09/2022 CELECOXIB
ANDA #078857		 SUPPL-13 CELECOXIB MYLAN Labeling Approval
03/09/2022 CELECOXIB
ANDA #204776		 SUPPL-10 CELECOXIB MICRO LABS Labeling Approval
03/09/2022 CELECOXIB
ANDA #207446		 SUPPL-11 CELECOXIB CIPLA Labeling Approval
03/09/2022 CLOBAZAM
ANDA #211032		 SUPPL-1 CLOBAZAM TEVA PHARMS USA Labeling Approval
03/09/2022 BEOVU
BLA #761125		 SUPPL-2 brolucizumab-dbll NOVARTIS PHARMS CORP Approval
03/10/2022 ALEVE
NDA #020204		 SUPPL-83 NAPROXEN SODIUM BAYER Labeling Approval
03/10/2022 ERYTHROMYCIN
ANDA #062746		 SUPPL-12 ERYTHROMYCIN AZURITY Labeling Approval
03/10/2022 ERYTHROMYCIN
ANDA #062746		 SUPPL-14 ERYTHROMYCIN AZURITY Labeling Approval
03/10/2022 CLOTRIMAZOLE
ANDA #074165		 SUPPL-43 CLOTRIMAZOLE P AND L Labeling Approval
03/10/2022 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-9 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
03/10/2022 RUFINAMIDE
ANDA #205075		 SUPPL-1 RUFINAMIDE GLENMARK PHARMS LTD Labeling Approval
03/10/2022 RUFINAMIDE
ANDA #205095		 SUPPL-2 RUFINAMIDE MYLAN Labeling Approval
03/10/2022 ZYDELIG
NDA #205858		 SUPPL-17 IDELALISIB GILEAD SCIENCES INC REMS Approval
03/10/2022 ENTERO VU 24%
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 LIQUID E-Z-PAQUE
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 READI-CAT 2
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 READI-CAT 2 SMOOTHIE
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 TAGITOL V
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 VARIBAR HONEY
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 VARIBAR NECTAR
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 VARIBAR THIN HONEY
NDA #208143		 SUPPL-13 BARIUM SULFATE BRACCO Manufacturing (CMC) Approval
03/10/2022 COLCHICINE
ANDA #209173		 ORIG-1 COLCHICINE STRIDES PHARMA Approval
03/10/2022 BUSULFAN
ANDA #210148		 SUPPL-2 BUSULFAN ACCORD HLTHCARE INC Labeling Approval
03/10/2022 VIGABATRIN
ANDA #211790		 ORIG-1 VIGABATRIN CHARTWELL RX Approval
03/10/2022 METHOTREXATE
NDA #214121		 SUPPL-1 METHOTREXATE ACCORD HLTHCARE Efficacy Approval
03/10/2022 NYSTATIN
ANDA #214346		 ORIG-1 NYSTATIN LEADING Approval
03/10/2022 COLESTIPOL HYDROCHLORIDE
ANDA #215223		 ORIG-1 COLESTIPOL HYDROCHLORIDE ZYDUS PHARMS Approval
03/11/2022 RISPERDAL
NDA #020588		 SUPPL-73 RISPERIDONE JANSSEN PHARMS Labeling Approval
03/11/2022 NESINA
NDA #022271		 SUPPL-13 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Labeling Approval
03/11/2022 OSENI
NDA #022426		 SUPPL-14 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
03/11/2022 NAPROXEN
ANDA #074140		 SUPPL-37 NAPROXEN GRANULES Labeling Approval
03/11/2022 NAPROXEN
ANDA #074140		 SUPPL-38 NAPROXEN GRANULES Labeling Approval
03/11/2022 NAPROXEN
ANDA #074140		 SUPPL-40 NAPROXEN GRANULES Labeling Approval
03/11/2022 NAPROXEN
ANDA #074140		 SUPPL-41 NAPROXEN GRANULES Labeling Approval
03/11/2022 NAPROXEN
ANDA #074140		 SUPPL-42 NAPROXEN GRANULES Manufacturing (CMC) Approval
03/11/2022 ONDANSETRON HYDROCHLORIDE
ANDA #079224		 SUPPL-18 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
03/11/2022 FINASTERIDE
ANDA #090061		 SUPPL-17 FINASTERIDE HETERO LABS LTD III Labeling Approval
03/11/2022 FINASTERIDE
ANDA #090061		 SUPPL-18 FINASTERIDE HETERO LABS LTD III Labeling Approval
03/11/2022 ONDANSETRON HYDROCHLORIDE
ANDA #090648		 SUPPL-14 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
03/11/2022 KAZANO
NDA #203414		 SUPPL-13 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
03/11/2022 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206180		 SUPPL-8 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA Labeling Approval
03/11/2022 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206180		 SUPPL-9 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA Labeling Approval
03/11/2022 FINASTERIDE
ANDA #207750		 SUPPL-1 FINASTERIDE ALKEM LABS LTD Labeling Approval
03/11/2022 FINASTERIDE
ANDA #207750		 SUPPL-6 FINASTERIDE ALKEM LABS LTD Labeling Approval
03/11/2022 LYNPARZA
NDA #208558		 SUPPL-23 OLAPARIB ASTRAZENECA Efficacy Approval
03/11/2022 MACITENTAN
ANDA #211128		 ORIG-1 MACITENTAN ALEMBIC PHARMS LTD Tentative Approval
03/11/2022 DAYVIGO
NDA #212028		 SUPPL-6 LEMBOREXANT EISAI INC Labeling Approval
03/11/2022 ADLARITY
NDA #212304		 ORIG-1 DONEPEZIL HYDROCHLORIDE CORIUM Type 3 - New Dosage Form Approval
03/11/2022 CISATRACURIUM BESYLATE
ANDA #212432		 ORIG-1 CISATRACURIUM BESYLATE PIRAMAL HLTHCARE UK Approval
03/11/2022 DIGOXIN
ANDA #215209		 ORIG-1 DIGOXIN AMICI Approval
03/14/2022 STROMECTOL
NDA #050742		 SUPPL-30 IVERMECTIN MERCK SHARP DOHME Labeling Approval
03/14/2022 METHYLPHENIDATE
ANDA #206497		 ORIG-1 METHYLPHENIDATE MYLAN TECH VIATRIS Approval
03/14/2022 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #206512		 SUPPL-4 AMLODIPINE BESYLATE; VALSARTAN AUROBINDO PHARMA Labeling Approval
03/14/2022 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #206512		 SUPPL-7 AMLODIPINE BESYLATE; VALSARTAN AUROBINDO PHARMA Labeling Approval
03/14/2022 CINVANTI
NDA #209296		 SUPPL-8 APREPITANT HERON THERAPS INC Manufacturing (CMC) Approval
03/14/2022 DOXEPIN HYDROCHLORIDE
ANDA #215483		 ORIG-1 DOXEPIN HYDROCHLORIDE JUBILANT CADISTA Approval
03/15/2022 MYFORTIC
NDA #050791		 SUPPL-35 MYCOPHENOLIC SODIUM NOVARTIS Labeling Approval
03/15/2022 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343		 SUPPL-11 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
03/15/2022 ONDANSETRON HYDROCHLORIDE
ANDA #077368		 SUPPL-10 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
03/15/2022 ONDANSETRON HYDROCHLORIDE
ANDA #077473		 SUPPL-14 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
03/15/2022 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077548		 SUPPL-15 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
03/15/2022 GALANTAMINE HYDROBROMIDE
ANDA #090178		 SUPPL-11 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
03/15/2022 GALANTAMINE HYDROBROMIDE
ANDA #090178		 SUPPL-13 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
03/15/2022 MARQIBO KIT
NDA #202497		 SUPPL-13 VINCRISTINE SULFATE ACROTECH Labeling Approval
03/15/2022 IBRUTINIB
ANDA #211267		 ORIG-1 IBRUTINIB SANDOZ INC Tentative Approval
03/15/2022 BREYNA
ANDA #211699		 ORIG-1 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE MYLAN Approval
03/15/2022 SUCRALFATE
ANDA #211884		 ORIG-1 SUCRALFATE VISTAPHARM LLC Approval
03/15/2022 DOXAZOSIN MESYLATE
ANDA #212727		 ORIG-1 DOXAZOSIN MESYLATE RISING Approval
03/15/2022 ATROPINE SULFATE
NDA #213581		 ORIG-1 ATROPINE SULFATE BAUSCH AND LOMB INC Type 5 - New Formulation or New Manufacturer Approval
03/15/2022 NEBIVOLOL HYDROCHLORIDE
ANDA #213830		 ORIG-1 NEBIVOLOL HYDROCHLORIDE UNICHEM Approval
03/15/2022 GUAIFENESIN
ANDA #215932		 ORIG-1 GUAIFENESIN DR REDDYS Approval
03/16/2022 REBETOL
NDA #020903		 SUPPL-57 RIBAVIRIN MERCK SHARP DOHME Labeling Approval
03/16/2022 FERRLECIT
NDA #020955		 SUPPL-20 FERRIC OXYHYDROXIDE SANOFI AVENTIS US Labeling Approval
03/16/2022 REBETOL
NDA #021546		 SUPPL-13 RIBAVIRIN SCHERING Labeling Approval
03/16/2022 METROGEL
NDA #021789		 SUPPL-9 METRONIDAZOLE GALDERMA LABS LP Labeling Approval
03/16/2022 METROGEL
NDA #021789		 SUPPL-10 METRONIDAZOLE GALDERMA LABS LP Labeling Approval
03/16/2022 CHLOROQUINE PHOSPHATE
ANDA #040516		 SUPPL-13 CHLOROQUINE PHOSPHATE IMPAX LABS Labeling Approval
03/16/2022 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-23 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/16/2022 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-24 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/16/2022 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-26 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/16/2022 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-28 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/16/2022 SANDIMMUNE
NDA #050625		 SUPPL-60 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
03/16/2022 CYCLAFEM 1/35
ANDA #076337		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ENDO OPERATIONS Labeling Approval
03/16/2022 CYCLAFEM 1/35
ANDA #076337		 SUPPL-10 ETHINYL ESTRADIOL; NORETHINDRONE ENDO OPERATIONS Labeling Approval
03/16/2022 SUCCINYLCHOLINE CHLORIDE
ANDA #211346		 SUPPL-1 SUCCINYLCHOLINE CHLORIDE FRESENIUS KABI USA Labeling Approval
03/16/2022 SPY AGENT GREEN KIT
NDA #211580		 SUPPL-4 INDOCYANINE GREEN NOVADAQ TECH Manufacturing (CMC) Approval
03/16/2022 RINVOQ
NDA #211675		 SUPPL-7 UPADACITINIB ABBVIE Efficacy Approval
03/17/2022 IC-GREEN
NDA #011525		 SUPPL-36 INDOCYANINE GREEN RENEW PHARMS Labeling Approval
03/17/2022 INVANZ
NDA #021337		 SUPPL-51 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
03/17/2022 EMOQUETTE
ANDA #076675		 SUPPL-12 DESOGESTREL; ETHINYL ESTRADIOL ENDO OPERATIONS Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #080880		 SUPPL-65 CHLOROQUINE PHOSPHATE IMPAX LABS Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #083082		 SUPPL-57 CHLOROQUINE PHOSPHATE HIKMA PHARMS Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #090249		 SUPPL-6 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #090610		 SUPPL-8 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #090612		 SUPPL-3 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #090612		 SUPPL-4 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
03/17/2022 LACOSAMIDE
ANDA #204787		 ORIG-1 LACOSAMIDE HETERO LABS LTD V Approval
03/17/2022 LACOSAMIDE
ANDA #204857		 ORIG-1 LACOSAMIDE AMNEAL PHARMS Approval
03/17/2022 GALANTAMINE HYDROBROMIDE
ANDA #204895		 SUPPL-5 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
03/17/2022 GALANTAMINE HYDROBROMIDE
ANDA #204895		 SUPPL-6 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
03/17/2022 GALANTAMINE HYDROBROMIDE
ANDA #204895		 SUPPL-7 GALANTAMINE HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
03/17/2022 LACOSAMIDE
ANDA #204921		 ORIG-1 LACOSAMIDE MSN LABS PVT LTD Approval
03/17/2022 LACOSAMIDE
ANDA #204974		 ORIG-1 LACOSAMIDE ALEMBIC Approval
03/17/2022 LACOSAMIDE
ANDA #205006		 ORIG-1 LACOSAMIDE GLENMARK PHARMS LTD Approval
03/17/2022 LACOSAMIDE
ANDA #205031		 ORIG-1 LACOSAMIDE SUN PHARM Approval
03/17/2022 LACOSAMIDE
ANDA #205237		 ORIG-1 LACOSAMIDE SCIEGEN PHARMS INC Approval
03/17/2022 PENTAMIDINE ISETHIONATE
ANDA #206982		 ORIG-1 PENTAMIDINE ISETHIONATE XGEN PHARMS Approval
03/17/2022 LACOSAMIDE
ANDA #208308		 ORIG-1 LACOSAMIDE INDOCO Approval
03/17/2022 CHLOROQUINE PHOSPHATE
ANDA #214756		 SUPPL-1 CHLOROQUINE PHOSPHATE SUVEN PHARMS Labeling Approval
03/17/2022 SUCCINYLCHOLINE CHLORIDE
NDA #215143		 SUPPL-1 SUCCINYLCHOLINE CHLORIDE HIKMA Labeling Approval
03/17/2022 NASONEX 24HR ALLERGY
NDA #215712		 ORIG-1 MOMETASONE FUROATE PERRIGO PHARMA INTL Type 8 - Partial Rx to OTC Switch Approval
03/17/2022 VERAPAMIL HYDROCHLORIDE
ANDA #215829		 ORIG-1 VERAPAMIL HYDROCHLORIDE ACIC PHARMS Approval
03/18/2022 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
NDA #050821		 SUPPL-6 CEFEPIME HYDROCHLORIDE B BRAUN Labeling Approval
03/18/2022 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202791		 SUPPL-4 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Labeling Approval
03/18/2022 CHABELINA FE
ANDA #202962		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
03/18/2022 BROMFENAC SODIUM
ANDA #204813		 ORIG-1 BROMFENAC SODIUM EUGIA PHARMA Approval
03/18/2022 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #205069		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Labeling Approval
03/18/2022 ATROPINE SULFATE
NDA #206289		 SUPPL-11 ATROPINE SULFATE RISING Labeling Approval
03/18/2022 LABETALOL HYDROCHLORIDE
NDA #213330		 SUPPL-3 LABETALOL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
03/18/2022 LABETALOL HYDROCHLORIDE IN DEXTROSE
NDA #213330		 SUPPL-3 LABETALOL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
03/18/2022 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
NDA #213330		 SUPPL-3 LABETALOL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
03/18/2022 WINLEVI
NDA #213433		 SUPPL-2 CLASCOTERONE SUN PHARM Labeling Approval
03/18/2022 ZTALMY
NDA #215904		 ORIG-1 GANAXOLONE MARINUS Type 1 - New Molecular Entity Approval
03/18/2022 CYLTEZO
BLA #761058		 SUPPL-11 ADALIMUMAB-ADBM BOEHRINGER INGELHEIM Approval
03/18/2022 OPDUALAG
BLA #761234		 ORIG-1 NIVOLUMAB;RELATLIMAB-RMBW BRISTOL MYERS SQUIBB Approval
03/21/2022 CHLOROQUINE PHOSPHATE
ANDA #091621		 SUPPL-3 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
03/21/2022 CHLOROQUINE PHOSPHATE
ANDA #091621		 SUPPL-4 CHLOROQUINE PHOSPHATE NATCO PHARMA LTD Labeling Approval
03/21/2022 KEYTRUDA
BLA #125514		 SUPPL-110 PEMBROLIZUMAB MERCK SHARP DOHME Approval
03/21/2022 JARDIANCE
NDA #204629		 SUPPL-34 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
03/21/2022 GLYXAMBI
NDA #206073		 SUPPL-31 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
03/21/2022 SYNJARDY
NDA #206111		 SUPPL-31 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/21/2022 DABIGATRAN ETEXILATE MESYLATE
ANDA #207922		 ORIG-1 DABIGATRAN ETEXILATE MESYLATE BRECKENRIDGE PHARMS Tentative Approval
03/21/2022 SYNJARDY XR
NDA #208658		 SUPPL-17 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
03/21/2022 IVERMECTIN
ANDA #212485		 ORIG-1 IVERMECTIN TEVA PHARMS USA Approval
03/21/2022 LOPINAVIR AND RITONAVIR
ANDA #213857		 ORIG-1 LOPINAVIR; RITONAVIR LAURUS Approval
03/21/2022 ESMOLOL HYDROCHLORIDE
ANDA #216244		 ORIG-1 ESMOLOL HYDROCHLORIDE EUGIA PHARMA Approval
03/22/2022 METRONIDAZOLE
ANDA #070027		 SUPPL-47 METRONIDAZOLE TEVA PHARMS USA Labeling Approval
03/22/2022 METRONIDAZOLE
ANDA #070027		 SUPPL-50 METRONIDAZOLE TEVA PHARMS USA Labeling Approval
03/22/2022 METRONIDAZOLE
ANDA #070033		 SUPPL-47 METRONIDAZOLE PLIVA Labeling Approval
03/22/2022 METRONIDAZOLE
ANDA #070033		 SUPPL-51 METRONIDAZOLE PLIVA Labeling Approval
03/22/2022 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-6 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
03/22/2022 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-7 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
03/22/2022 CYRAMZA
BLA #125477		 SUPPL-42 RAMUCIRUMAB ELI LILLY AND CO Approval
03/22/2022 SMOFLIPID 20%
NDA #207648		 SUPPL-5 FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL FRESENIUS KABI USA Efficacy Approval
03/22/2022 IBUPROFEN
ANDA #208865		 SUPPL-9 IBUPROFEN AUROBINDO PHARMA Manufacturing (CMC) Approval
03/22/2022 HYFTOR
NDA #213478		 ORIG-1 SIROLIMUS NOBELPHARMA Type 3 - New Dosage Form Approval
03/22/2022 PREGABALIN
ANDA #215249		 ORIG-1 PREGABALIN RUBICON Approval
03/22/2022 XELSTRYM
NDA #215401		 ORIG-1 DEXTROAMPHETAMINE NOVEN PHARMS INC Type 3 - New Dosage Form Approval
03/22/2022 EMPLICITI
BLA #761035		 SUPPL-15 ELOTUZUMAB BRISTOL MYERS SQUIBB Approval
03/23/2022 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-48 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Labeling Approval
03/23/2022 DIAZEPAM
ANDA #071309		 SUPPL-8 DIAZEPAM HIKMA Labeling Approval
03/23/2022 DIAZEPAM
ANDA #071310		 SUPPL-9 DIAZEPAM HIKMA Labeling Approval
03/23/2022 DIAZEPAM
ANDA #210363		 SUPPL-7 DIAZEPAM BELOTECA Labeling Approval
03/23/2022 SILDENAFIL CITRATE
ANDA #211638		 ORIG-1 SILDENAFIL CITRATE LUPIN LTD Approval
03/23/2022 VOCABRIA
NDA #212887		 SUPPL-3 CABOTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
03/23/2022 CABENUVA KIT
NDA #212888		 SUPPL-3 CABOTEGRAVIR; RILPIVIRINE VIIV HLTHCARE Efficacy Approval
03/23/2022 EPLERENONE
ANDA #214663		 ORIG-1 EPLERENONE RISING Approval
03/23/2022 AMINOCAPROIC ACID
ANDA #215510		 ORIG-1 AMINOCAPROIC ACID FLORIDA Approval
03/23/2022 KETOROLAC TROMETHAMINE
ANDA #215788		 ORIG-1 KETOROLAC TROMETHAMINE SENORES PHARMS Approval
03/23/2022 PLUVICTO
NDA #215833		 ORIG-1 LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN NOVARTIS Type 1 - New Molecular Entity Approval
03/23/2022 LOCAMETZ
NDA #215841		 ORIG-1 GALLIUM GA-68 GOZETOTIDE NOVARTIS Type 2 - New Active Ingredient Approval
03/23/2022 LIDOCAINE HYDROCHLORIDE
ANDA #216250		 ORIG-1 LIDOCAINE HYDROCHLORIDE NOVITIUM PHARMA Approval
03/24/2022 CISPLATIN
NDA #018057		 SUPPL-92 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/24/2022 PLATINOL
NDA #018057		 SUPPL-92 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/24/2022 PLATINOL-AQ
NDA #018057		 SUPPL-92 CISPLATIN HQ SPCLT PHARMA Labeling Approval
03/24/2022 GLEEVEC
NDA #021588		 SUPPL-60 IMATINIB MESYLATE NOVARTIS Labeling Approval
03/24/2022 INVEGA
NDA #021999		 SUPPL-39 PALIPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
03/24/2022 CALQUENCE
NDA #210259		 SUPPL-9 ACALABRUTINIB ASTRAZENECA Labeling Approval
03/24/2022 YONSA
NDA #210308		 SUPPL-3 ABIRATERONE ACETATE SUN PHARM Labeling Approval
03/24/2022 INQOVI
NDA #212576		 SUPPL-3 CEDAZURIDINE; DECITABINE OTSUKA Labeling Approval
03/24/2022 POTASSIUM CHLORIDE
ANDA #214108		 ORIG-1 POTASSIUM CHLORIDE RUBICON Approval
03/24/2022 CLOBAZAM
ANDA #214404		 ORIG-1 CLOBAZAM AUROBINDO PHARMA LTD Approval
03/24/2022 VEKLURY
NDA #214787		 SUPPL-13 REMDESIVIR GILEAD SCIENCES INC Labeling Approval
03/25/2022 CIPRO
NDA #019847		 SUPPL-63 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/25/2022 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-73 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/25/2022 FINTEPLA
NDA #212102		 SUPPL-3 FENFLURAMINE HYDROCHLORIDE UCB INC Efficacy Approval
03/25/2022 PIRFENIDONE
ANDA #212570		 ORIG-1 PIRFENIDONE AMNEAL Approval
03/25/2022 PRADAXA
NDA #214358		 SUPPL-1 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
03/25/2022 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #215135		 ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE HIKMA Approval
03/27/2022 TYKERB
NDA #022059		 SUPPL-31 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
03/28/2022 CAPRELSA
NDA #022405		 SUPPL-19 VANDETANIB GENZYME CORP Labeling Approval
03/28/2022 FEBUXOSTAT
ANDA #206266		 ORIG-1 FEBUXOSTAT PRINSTON INC Approval
03/28/2022 EXEMESTANE
ANDA #206421		 SUPPL-6 EXEMESTANE AMNEAL PHARMS Labeling Approval
03/28/2022 TLANDO
NDA #208088		 ORIG-1 TESTOSTERONE UNDECANOATE VERITY Type 3 - New Dosage Form Approval
03/28/2022 LEVETIRACETAM
ANDA #209474		 ORIG-1 LEVETIRACETAM PRINSTON INC Approval
03/28/2022 OSELTAMIVIR PHOSPHATE
ANDA #209590		 ORIG-1 OSELTAMIVIR PHOSPHATE HETERO LABS LTD V Approval
03/28/2022 OZEMPIC
NDA #209637		 SUPPL-9 SEMAGLUTIDE NOVO Efficacy Approval
03/28/2022 ALYQ
ANDA #209942		 SUPPL-5 TADALAFIL TEVA PHARMS USA Labeling Approval
03/28/2022 DEXTROSE 5% AND LACTATED RINGER'S
ANDA #210332		 ORIG-1 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS KABI USA Approval
03/28/2022 TOLVAPTAN
ANDA #211891		 SUPPL-1 TOLVAPTAN ALKEM LABS LTD Labeling Approval
03/28/2022 XPOVIO
NDA #212306		 SUPPL-10 SELINEXOR KARYOPHARM THERAPS Labeling Approval
03/28/2022 ABIRATERONE ACETATE
ANDA #212462		 SUPPL-4 ABIRATERONE ACETATE QILU Labeling Approval
03/28/2022 RAMELTEON
ANDA #213186		 SUPPL-4 RAMELTEON GRANULES Labeling Approval
03/28/2022 PREDNISONE
ANDA #215672		 ORIG-1 PREDNISONE AUROBINDO PHARMA LTD Approval
03/28/2022 HYRIMOZ
BLA #761071		 SUPPL-11 ADALIMUMAB-ADAZ SANDOZ INC Approval
03/29/2022 PLEGRIDY
BLA #125499		 SUPPL-25 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
03/29/2022 EDURANT
NDA #202022		 SUPPL-17 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Efficacy Approval
03/29/2022 EDURANT
NDA #202022		 SUPPL-18 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Efficacy Approval
03/29/2022 VOCABRIA
NDA #212887		 SUPPL-5 CABOTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
03/29/2022 VOCABRIA
NDA #212887		 SUPPL-6 CABOTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
03/29/2022 CABENUVA KIT
NDA #212888		 SUPPL-5 CABOTEGRAVIR; RILPIVIRINE VIIV HLTHCARE Efficacy Approval
03/29/2022 CABENUVA KIT
NDA #212888		 SUPPL-6 CABOTEGRAVIR; RILPIVIRINE VIIV HLTHCARE Efficacy Approval
03/29/2022 BRIVARACETAM
ANDA #214880		 ORIG-1 BRIVARACETAM MICRO LABS Tentative Approval
03/29/2022 NIFEDIPINE
ANDA #216067		 ORIG-1 NIFEDIPINE ALKEM LABS LTD Approval
03/29/2022 FLUOXETINE HYDROCHLORIDE
ANDA #216232		 ORIG-1 FLUOXETINE HYDROCHLORIDE MICRO LABS Approval
03/30/2022 FUROSEMIDE
NDA #018579		 SUPPL-33 FUROSEMIDE AM REGENT Manufacturing (CMC) Approval
03/30/2022 TRIUMEQ
NDA #205551		 SUPPL-28 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
03/30/2022 TISSUEBLUE
NDA #209569		 SUPPL-4 BRILLIANT BLUE G DUTCH OPHTHALMIC Labeling Approval
03/30/2022 SODIUM PHOSPHATES
ANDA #209997		 ORIG-1 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS FRESENIUS KABI USA Approval
03/30/2022 RIOCIGUAT
ANDA #211044		 ORIG-1 RIOCIGUAT TEVA PHARMS USA INC Tentative Approval
03/30/2022 DOXYCYCLINE HYCLATE
ANDA #212487		 ORIG-1 DOXYCYCLINE HYCLATE PRAXGEN Approval
03/30/2022 DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
NDA #212527		 ORIG-1 DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE CIPLA USA INC. Type 4 - New Combination Tentative Approval
03/30/2022 ENALAPRIL MALEATE
ANDA #213714		 ORIG-1 ENALAPRIL MALEATE ALKEM LABS LTD Approval
03/30/2022 IOFLUPANE I-123
ANDA #213792		 ORIG-1 IOFLUPANE I-123 CURIUM Approval
03/30/2022 IBUPROFEN
ANDA #215318		 ORIG-1 IBUPROFEN YICHANG HUMANWELL Approval
03/30/2022 TRIUMEQ PD
NDA #215413		 ORIG-1 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Type 3 - New Dosage Form Approval
03/30/2022 POTELIGEO
BLA #761051		 SUPPL-15 MOGAMULIZUMAB-KPKC KYOWA KIRIN Approval
03/31/2022 PROMACTA
NDA #022291		 SUPPL-33 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
03/31/2022 DIPYRIDAMOLE
ANDA #040782		 SUPPL-14 DIPYRIDAMOLE IMPAX LABS Labeling Approval
03/31/2022 METRONIDAZOLE
ANDA #070039		 SUPPL-15 METRONIDAZOLE STRIDES PHARMA Labeling Approval
03/31/2022 METRONIDAZOLE
ANDA #070040		 SUPPL-15 METRONIDAZOLE STRIDES PHARMA Labeling Approval
03/31/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #071017		 SUPPL-70 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
03/31/2022 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #071017		 SUPPL-72 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
03/31/2022 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #075579		 SUPPL-25 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE EPIC PHARMA LLC Labeling Approval
03/31/2022 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #075579		 SUPPL-27 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE EPIC PHARMA LLC Labeling Approval
03/31/2022 PAROXETINE HYDROCHLORIDE
ANDA #077395		 SUPPL-14 PAROXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
03/31/2022 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894		 SUPPL-6 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Labeling Approval
03/31/2022 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894		 SUPPL-8 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Labeling Approval
03/31/2022 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 SUPPL-13 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/31/2022 METRONIDAZOLE
ANDA #203458		 SUPPL-14 METRONIDAZOLE UNICHEM Labeling Approval
03/31/2022 JUBLIA
NDA #203567		 SUPPL-10 EFINACONAZOLE BAUSCH Labeling Approval
03/31/2022 METRONIDAZOLE
ANDA #203974		 SUPPL-10 METRONIDAZOLE AUROBINDO PHARMA LTD Labeling Approval
03/31/2022 CLOPIDOGREL BISULFATE
ANDA #204165		 SUPPL-18 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
03/31/2022 GABAPENTIN
ANDA #206402		 SUPPL-20 GABAPENTIN ALKEM LABS LTD Labeling Approval
03/31/2022 PROMACTA KIT
NDA #207027		 SUPPL-15 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
03/31/2022 OXALIPLATIN
ANDA #207562		 SUPPL-6 OXALIPLATIN NOVAST LABS Labeling Approval
03/31/2022 WIXELA INHUB
ANDA #208891		 SUPPL-9 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE MYLAN Labeling Approval
03/31/2022 METRONIDAZOLE
ANDA #209096		 SUPPL-3 METRONIDAZOLE LUPIN LTD Labeling Approval
03/31/2022 DAPSONE
ANDA #210178		 ORIG-1 DAPSONE COSETTE Approval
03/31/2022 POTASSIUM CHLORIDE
ANDA #211067		 SUPPL-2 POTASSIUM CHLORIDE APOTEX Labeling Approval
03/31/2022 TEGSEDI
NDA #211172		 SUPPL-11 INOTERSEN SODIUM AKCEA THERAPS REMS Approval
03/31/2022 SUCCINYLCHOLINE CHLORIDE
ANDA #212638		 SUPPL-2 SUCCINYLCHOLINE CHLORIDE BRECKENRIDGE Labeling Approval
03/31/2022 NURTEC ODT
NDA #212728		 SUPPL-14 RIMEGEPANT SULFATE PFIZER Manufacturing (CMC) Approval
03/31/2022 EPHEDRINE SULFATE
ANDA #212932		 SUPPL-1 EPHEDRINE SULFATE AMNEAL Labeling Approval
03/31/2022 EPHEDRINE SULFATE
ANDA #212932		 SUPPL-2 EPHEDRINE SULFATE AMNEAL Labeling Approval
03/31/2022 NEBIVOLOL HYDROCHLORIDE
ANDA #213349		 ORIG-1 NEBIVOLOL HYDROCHLORIDE AJANTA PHARMA LTD Approval
03/31/2022 POTASSIUM CITRATE
ANDA #214420		 SUPPL-1 POTASSIUM CITRATE ASCENT PHARMS INC Labeling Approval
03/31/2022 POTASSIUM CITRATE
ANDA #214426		 SUPPL-4 POTASSIUM CITRATE EYWA Labeling Approval
03/31/2022 EPHEDRINE SULFATE
ANDA #214579		 SUPPL-1 EPHEDRINE SULFATE EUGIA PHARMA Labeling Approval
03/31/2022 LACOSAMIDE
ANDA #214695		 ORIG-1 LACOSAMIDE ALKEM LABS LTD Approval
03/31/2022 SUCCINYLCHOLINE CHLORIDE
ANDA #214879		 SUPPL-4 SUCCINYLCHOLINE CHLORIDE MICRO LABS Labeling Approval
03/31/2022 SUCCINYLCHOLINE CHLORIDE
ANDA #214879		 SUPPL-5 SUCCINYLCHOLINE CHLORIDE MICRO LABS Labeling Approval
03/31/2022 CARBAMAZEPINE
ANDA #215591		 ORIG-1 CARBAMAZEPINE ZHEJIANG JIUZHOU Approval
03/31/2022 ACYCLOVIR
ANDA #216331		 ORIG-1 ACYCLOVIR AUROBINDO PHARMA Approval
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