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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2021

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 April 24, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2021 RISPERIDONE
ANDA #076288		 SUPPL-20 RISPERIDONE DASH PHARMS Labeling Approval
10/01/2021 LITHIUM CARBONATE
ANDA #090702		 SUPPL-7 LITHIUM CARBONATE HETERO LABS LTD III Labeling Approval
10/01/2021 LITHIUM CARBONATE
ANDA #090702		 SUPPL-10 LITHIUM CARBONATE HETERO LABS LTD III Labeling Approval
10/01/2021 ONDANSETRON HYDROCHLORIDE
ANDA #091483		 SUPPL-7 ONDANSETRON HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
10/01/2021 RAMIPRIL
ANDA #091604		 SUPPL-10 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
10/01/2021 LEVETIRACETAM
ANDA #201464		 SUPPL-3 LEVETIRACETAM PHARMADAX INC Labeling Approval
10/01/2021 EZETIMIBE AND SIMVASTATIN
ANDA #202968		 SUPPL-5 EZETIMIBE; SIMVASTATIN WATSON LABS INC Labeling Approval
10/01/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #206845		 SUPPL-2 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/01/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #206845		 SUPPL-7 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/01/2021 ONDANSETRON HYDROCHLORIDE
ANDA #206846		 SUPPL-2 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/01/2021 ONDANSETRON HYDROCHLORIDE
ANDA #206846		 SUPPL-7 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
10/01/2021 JENTADUETO XR
NDA #208026		 SUPPL-20 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
10/01/2021 NEOSTIGMINE METHYLSULFATE
ANDA #210652		 ORIG-1 NEOSTIGMINE METHYLSULFATE INDOCO Approval
10/01/2021 CASPOFUNGIN ACETATE
ANDA #211263		 ORIG-1 CASPOFUNGIN ACETATE AREVA PHARMS Approval
10/01/2021 TALICIA
NDA #213004		 SUPPL-4 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN REDHILL Labeling Approval
10/01/2021 MEXILETINE HYDROCHLORIDE
ANDA #214089		 ORIG-1 MEXILETINE HYDROCHLORIDE SENORES PHARMS Approval
10/01/2021 GABAPENTIN
ANDA #214957		 ORIG-1 GABAPENTIN ASCENT PHARMS INC Approval
10/01/2021 OSELTAMIVIR PHOSPHATE
ANDA #215208		 ORIG-1 OSELTAMIVIR PHOSPHATE EPIC PHARMA LLC Approval
10/01/2021 DUPIXENT
BLA #761055		 SUPPL-35 DUPILUMAB REGENERON PHARMACEUTICALS Approval
10/01/2021 SOGROYA
BLA #761156		 SUPPL-1 SOMAPACITAN-BECO NOVO NORDISK INC Approval
10/01/2021 SOGROYA
BLA #761156		 SUPPL-2 SOMAPACITAN-BECO NOVO NORDISK INC Approval
10/04/2021 ESTRADIOL
NDA #020538		 SUPPL-37 ESTRADIOL SANDOZ Labeling Approval
10/04/2021 ESTRADIOL
NDA #020538		 SUPPL-39 ESTRADIOL SANDOZ Labeling Approval
10/04/2021 VIVELLE-DOT
NDA #020538		 SUPPL-37 ESTRADIOL SANDOZ Labeling Approval
10/04/2021 VIVELLE-DOT
NDA #020538		 SUPPL-39 ESTRADIOL SANDOZ Labeling Approval
10/04/2021 VENCLEXTA
NDA #208573		 SUPPL-24 VENETOCLAX ABBVIE Efficacy Approval
10/04/2021 TRIKAFTA (COPACKAGED)
NDA #212273		 SUPPL-8 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR VERTEX PHARMS INC Labeling Approval
10/04/2021 FOSAPREPITANT DIMEGLUMINE
ANDA #213199		 ORIG-1 FOSAPREPITANT DIMEGLUMINE ARTHUR GRP Approval
10/04/2021 OXYMETAZOLINE HYDROCHLORIDE
ANDA #213584		 ORIG-1 OXYMETAZOLINE HYDROCHLORIDE TARO Approval
10/04/2021 SERTRALINE HYDROCHLORIDE
NDA #215133		 ORIG-1 SERTRALINE HYDROCHLORIDE ALMATICA Type 3 - New Dosage Form Approval
10/04/2021 SERTRALINE HYDROCHLORIDE
NDA #215133		 ORIG-2 SERTRALINE HYDROCHLORIDE ALMATICA Type 3 - New Dosage Form Approval
10/05/2021 REMICADE
BLA #103772		 SUPPL-5401 INFLIXIMAB CENTOCOR INC Approval
10/05/2021 VALSARTAN
ANDA #201618		 ORIG-1 VALSARTAN DR REDDYS Approval
10/05/2021 CARBIDOPA AND LEVODOPA
ANDA #214091		 ORIG-1 CARBIDOPA; LEVODOPA SCIEGEN PHARMS INC Approval
10/06/2021 PROZAC
NDA #018936		 SUPPL-111 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
10/06/2021 SARAFEM
NDA #018936		 SUPPL-111 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
10/06/2021 FLUCONAZOLE
ANDA #076077		 SUPPL-18 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
10/06/2021 FLUCONAZOLE
ANDA #077253		 SUPPL-18 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
10/06/2021 FLUCONAZOLE
ANDA #077731		 SUPPL-23 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
10/06/2021 FLUCONAZOLE
ANDA #208963		 SUPPL-9 FLUCONAZOLE ZYDUS PHARMS Labeling Approval
10/06/2021 ASPIRIN AND DIPYRIDAMOLE
ANDA #209048		 SUPPL-2 ASPIRIN; DIPYRIDAMOLE DR REDDYS Labeling Approval
10/06/2021 ASPIRIN AND DIPYRIDAMOLE
ANDA #209048		 SUPPL-5 ASPIRIN; DIPYRIDAMOLE DR REDDYS Labeling Approval
10/06/2021 SUGAMMADEX SODIUM
ANDA #214364		 ORIG-1 SUGAMMADEX SODIUM GLAND PHARMA LTD Tentative Approval
10/06/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #215001		 ORIG-1 LOPERAMIDE HYDROCHLORIDE EDENBRIDGE PHARMS Approval
10/06/2021 TECENTRIQ
BLA #761034		 SUPPL-44 ATEZOLIZUMAB GENENTECH INC Approval
10/07/2021 CLIMARA PRO
NDA #021258		 SUPPL-13 ESTRADIOL; LEVONORGESTREL BAYER HLTHCARE Labeling Approval
10/07/2021 EFAVIRENZ
ANDA #091471		 SUPPL-2 EFAVIRENZ MYLAN Labeling Approval
10/07/2021 EFAVIRENZ
ANDA #091471		 SUPPL-4 EFAVIRENZ MYLAN Labeling Approval
10/07/2021 EFAVIRENZ
ANDA #091471		 SUPPL-5 EFAVIRENZ MYLAN Labeling Approval
10/07/2021 LEVETIRACETAM
ANDA #091491		 SUPPL-11 LEVETIRACETAM ZHEJIANG JINGXIN Labeling Approval
10/07/2021 LEVETIRACETAM
ANDA #091491		 SUPPL-12 LEVETIRACETAM ZHEJIANG JINGXIN Labeling Approval
10/07/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #201806		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE HETERO LABS LTD III Approval
10/07/2021 TOPICORT
NDA #204141		 SUPPL-9 DESOXIMETASONE TARO Efficacy Approval
10/07/2021 ZYKADIA
NDA #205755		 SUPPL-19 CERITINIB NOVARTIS Labeling Approval
10/07/2021 DEXTENZA
NDA #208742		 SUPPL-7 DEXAMETHASONE OCULAR THERAPEUTIX Efficacy Approval
10/07/2021 BIKTARVY
NDA #210251		 SUPPL-14 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
10/07/2021 ZYKADIA
NDA #211225		 SUPPL-4 CERITINIB NOVARTIS Labeling Approval
10/07/2021 TAVNEOS
NDA #214487		 ORIG-1 AVACOPAN CHEMOCENTRYX Type 1 - New Molecular Entity Approval
10/07/2021 FLUOROURACIL
ANDA #214845		 ORIG-1 FLUOROURACIL ACCORD HLTHCARE Approval
10/07/2021 ARSENIC TRIOXIDE
ANDA #215059		 ORIG-1 ARSENIC TRIOXIDE GLAND PHARMA LTD Approval
10/08/2021 ABSORICA
NDA #021951		 SUPPL-18 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
10/08/2021 CEFAZOLIN AND DEXTROSE
NDA #050779		 SUPPL-31 CEFAZOLIN SODIUM B BRAUN Labeling Approval
10/08/2021 CEFUROXIME SODIUM
ANDA #064124		 SUPPL-18 CEFUROXIME SODIUM ACS DOBFAR SPA Labeling Approval
10/08/2021 CEFUROXIME SODIUM
ANDA #064125		 SUPPL-13 CEFUROXIME SODIUM ACS DOBFAR SPA Labeling Approval
10/08/2021 FLUOXETINE
ANDA #075662		 SUPPL-2 FLUOXETINE HYDROCHLORIDE WATSON LABS Labeling Approval
10/08/2021 AMNESTEEM
ANDA #075945		 SUPPL-40 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
10/08/2021 CLARAVIS
ANDA #076135		 SUPPL-52 ISOTRETINOIN TEVA PHARMS USA REMS Approval
10/08/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076237		 SUPPL-6 FLUOXETINE HYDROCHLORIDE BARR Labeling Approval
10/08/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076237		 SUPPL-7 FLUOXETINE HYDROCHLORIDE BARR Labeling Approval
10/08/2021 CLARAVIS
ANDA #076356		 SUPPL-47 ISOTRETINOIN TEVA PHARMS USA REMS Approval
10/08/2021 MYORISAN
ANDA #076485		 SUPPL-27 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
10/08/2021 ZENATANE
ANDA #202099		 SUPPL-24 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
10/08/2021 ISOTRETINOIN
ANDA #205063		 SUPPL-1 ISOTRETINOIN ACTAVIS LABS FL REMS Approval
10/08/2021 ISOTRETINOIN
ANDA #207792		 SUPPL-14 ISOTRETINOIN AMNEAL PHARMS NY REMS Approval
10/08/2021 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
ANDA #207823		 ORIG-1 METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE SUN PHARM INDS LTD Tentative Approval
10/08/2021 ALVIMOPAN
ANDA #208295		 SUPPL-2 ALVIMOPAN WATSON LABS TEVA Labeling Approval
10/08/2021 CLOBAZAM
ANDA #209718		 SUPPL-3 CLOBAZAM AMNEAL PHARMS CO Labeling Approval
10/08/2021 CLOBAZAM
ANDA #209795		 SUPPL-2 CLOBAZAM HETERO LABS LTD III Labeling Approval
10/08/2021 ABSORICA LD
NDA #211913		 SUPPL-4 ISOTRETINOIN SUN PHARM REMS Approval
10/08/2021 ISOTRETINOIN
ANDA #212333		 SUPPL-1 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
10/08/2021 SILDENAFIL CITRATE
ANDA #212883		 SUPPL-3 SILDENAFIL CITRATE AJANTA PHARMA LTD Labeling Approval
10/08/2021 DASATINIB
ANDA #213383		 ORIG-1 DASATINIB DR REDDYS LABS LTD Tentative Approval
10/08/2021 ISOTRETINOIN
ANDA #213571		 SUPPL-1 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
10/08/2021 PENICILLAMINE
ANDA #214363		 ORIG-1 PENICILLAMINE NAVINTA LLC Approval
10/08/2021 DICLOFENAC POTASSIUM
ANDA #215585		 ORIG-1 DICLOFENAC POTASSIUM NOVAST LABS Approval
10/12/2021 ELIQUIS
NDA #202155		 SUPPL-34 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
10/12/2021 MINIVELLE
NDA #203752		 SUPPL-16 ESTRADIOL NOVEN Labeling Approval
10/12/2021 ROMIDEPSIN
ANDA #206254		 ORIG-1 ROMIDEPSIN FRESENIUS KABI USA Approval
10/12/2021 PROPOFOL
ANDA #206408		 ORIG-1 PROPOFOL AVET LIFESCIENCES Approval
10/12/2021 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #207228		 ORIG-1 DOXORUBICIN HYDROCHLORIDE AYANA PHARMA LTD Approval
10/12/2021 VERZENIO
NDA #208716		 SUPPL-6 ABEMACICLIB ELI LILLY AND CO Efficacy Approval
10/12/2021 VERZENIO
NDA #208716		 SUPPL-7 ABEMACICLIB ELI LILLY AND CO Efficacy Approval
10/12/2021 VERZENIO
NDA #208716		 SUPPL-8 ABEMACICLIB ELI LILLY AND CO Efficacy Approval
10/12/2021 MIVACURIUM CHLORIDE
ANDA #209708		 ORIG-1 MIVACURIUM CHLORIDE WOODWARD Approval
10/12/2021 METHOTREXATE SODIUM
ANDA #210040		 SUPPL-1 METHOTREXATE SODIUM AMNEAL PHARMS Labeling Approval
10/12/2021 METHOTREXATE SODIUM
ANDA #210040		 SUPPL-8 METHOTREXATE SODIUM AMNEAL PHARMS Labeling Approval
10/13/2021 AGRYLIN
NDA #020333		 SUPPL-27 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
10/13/2021 ALLEGRA ALLERGY
NDA #020872		 SUPPL-46 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/13/2021 ALLEGRA HIVES
NDA #020872		 SUPPL-46 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/13/2021 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-46 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/13/2021 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-46 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/13/2021 VFEND
NDA #021266		 SUPPL-51 VORICONAZOLE PF PRISM CV Labeling Approval
10/13/2021 VFEND
NDA #021267		 SUPPL-61 VORICONAZOLE PF PRISM CV Labeling Approval
10/13/2021 VFEND
NDA #021630		 SUPPL-40 VORICONAZOLE PF PRISM CV Labeling Approval
10/13/2021 POLYETHYLENE GLYCOL 3350
ANDA #090685		 SUPPL-11 POLYETHYLENE GLYCOL 3350 PERRIGO R AND D Labeling Approval
10/13/2021 POLYETHYLENE GLYCOL 3350
ANDA #090685		 SUPPL-13 POLYETHYLENE GLYCOL 3350 PERRIGO R AND D Labeling Approval
10/13/2021 KEYTRUDA
BLA #125514		 SUPPL-121 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/13/2021 KEYTRUDA
BLA #125514		 SUPPL-122 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/13/2021 GLYCOPYRROLATE
ANDA #212591		 ORIG-1 GLYCOPYRROLATE NIVAGEN PHARMS INC Approval
10/13/2021 CARGLUMIC ACID
ANDA #213729		 ORIG-1 CARGLUMIC ACID NOVITIUM PHARMA Approval
10/14/2021 EFUDEX
NDA #016831		 SUPPL-63 FLUOROURACIL BAUSCH Labeling Approval
10/14/2021 VIMPAT
NDA #022253		 SUPPL-49 LACOSAMIDE UCB INC Efficacy Approval
10/14/2021 VIMPAT
NDA #022254		 SUPPL-39 LACOSAMIDE UCB INC Efficacy Approval
10/14/2021 VIMPAT
NDA #022255		 SUPPL-31 LACOSAMIDE UCB INC Efficacy Approval
10/14/2021 BELRAPZO
NDA #205580		 SUPPL-10 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
10/14/2021 COLESEVELAM HYDROCHLORIDE
ANDA #206036		 ORIG-1 COLESEVELAM HYDROCHLORIDE BEIJING TIDE PHARM Approval
10/14/2021 BENDEKA
NDA #208194		 SUPPL-24 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
10/14/2021 LENALIDOMIDE
ANDA #209348		 ORIG-1 LENALIDOMIDE DR REDDYS Approval
10/14/2021 BENZTROPINE MESYLATE
ANDA #209442		 ORIG-1 BENZTROPINE MESYLATE HIKMA Approval
10/14/2021 DOPTELET
NDA #210238		 SUPPL-6 AVATROMBOPAG MALEATE AKARX INC Labeling Approval
10/14/2021 DOFETILIDE
ANDA #212750		 ORIG-1 DOFETILIDE GRANULES Approval
10/14/2021 METRONIDAZOLE
ANDA #213648		 ORIG-1 METRONIDAZOLE SOLARIS PHARMA CORP Approval
10/14/2021 DEXAMETHASONE
ANDA #215106		 ORIG-1 DEXAMETHASONE AMNEAL Approval
10/15/2021 SULFAMETHOXAZOLE AND TRIMETHOPRIM
NDA #018598		 SUPPL-54 SULFAMETHOXAZOLE; TRIMETHOPRIM FOSUN PHARMA Labeling Approval
10/15/2021 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
NDA #018598		 SUPPL-54 SULFAMETHOXAZOLE; TRIMETHOPRIM FOSUN PHARMA Labeling Approval
10/15/2021 SULFATRIM
NDA #018615		 SUPPL-80 SULFAMETHOXAZOLE; TRIMETHOPRIM PHARM ASSOC Labeling Approval
10/15/2021 SULFATRIM PEDIATRIC
NDA #018615		 SUPPL-80 SULFAMETHOXAZOLE; TRIMETHOPRIM PHARM ASSOC Labeling Approval
10/15/2021 COZAAR
NDA #020386		 SUPPL-64 LOSARTAN POTASSIUM ORGANON Labeling Approval
10/15/2021 LO LOESTRIN FE
NDA #022501		 SUPPL-12 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
10/15/2021 TRI-LEGEST FE
ANDA #076105		 SUPPL-13 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
10/15/2021 LANSOPRAZOLE
ANDA #077255		 SUPPL-22 LANSOPRAZOLE TEVA PHARMS Labeling Approval
10/15/2021 TELMISARTAN
ANDA #090032		 SUPPL-6 TELMISARTAN GLENMARK PHARMS LTD Manufacturing (CMC) Approval
10/15/2021 LANSOPRAZOLE
ANDA #090331		 SUPPL-24 LANSOPRAZOLE SANDOZ Labeling Approval
10/15/2021 LANSOPRAZOLE
ANDA #090331		 SUPPL-25 LANSOPRAZOLE SANDOZ Labeling Approval
10/15/2021 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-16 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/15/2021 LANSOPRAZOLE
ANDA #091269		 SUPPL-17 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
10/15/2021 LANSOPRAZOLE
ANDA #091269		 SUPPL-18 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
10/15/2021 CAPECITABINE
ANDA #200483		 SUPPL-6 CAPECITABINE HIKMA Labeling Approval
10/15/2021 GABAPENTIN
ANDA #200651		 SUPPL-22 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/15/2021 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-17 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/15/2021 TRANEXAMIC ACID
ANDA #203256		 SUPPL-1 TRANEXAMIC ACID ANI PHARMS Labeling Approval
10/15/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203575		 SUPPL-3 MYCOPHENOLATE MOFETIL HYDROCHLORIDE PAR STERILE PRODUCTS Labeling Approval
10/15/2021 MONTELUKAST SODIUM
ANDA #210431		 SUPPL-4 MONTELUKAST SODIUM TORRENT Labeling Approval
10/15/2021 ZIMHI
NDA #212854		 ORIG-1 NALOXONE HYDROCHLORIDE ADAMIS PHARMS CORP Type 5 - New Formulation or New Manufacturer Approval
10/15/2021 SEGLENTIS
NDA #213426		 ORIG-1 CELECOXIB; TRAMADOL HYDROCHLORIDE KOWA PHARMS Type 4 - New Combination Approval
10/15/2021 TYRVAYA
NDA #213978		 ORIG-1 VARENICLINE TARTRATE OYSTER POINT PHARMA Type 3 - New Dosage Form Approval
10/15/2021 ARSENIC TRIOXIDE
ANDA #214011		 ORIG-1 ARSENIC TRIOXIDE EUGIA PHARMA Approval
10/15/2021 FAMOTIDINE
ANDA #215689		 ORIG-1 FAMOTIDINE ASCENT PHARMS INC Approval
10/15/2021 TECENTRIQ
BLA #761034		 SUPPL-42 ATEZOLIZUMAB GENENTECH INC Approval
10/15/2021 CYLTEZO
BLA #761058		 SUPPL-8 ADALIMUMAB-ADBM BOEHRINGER INGELHEIM Approval
10/18/2021 LOTRIMIN ULTRA
NDA #021307		 SUPPL-19 BUTENAFINE HYDROCHLORIDE BAYER HEALTHCARE LLC Labeling Approval
10/18/2021 CHLORHEXIDINE GLUCONATE
ANDA #074522		 SUPPL-17 CHLORHEXIDINE GLUCONATE PHARM ASSOC Manufacturing (CMC) Approval
10/18/2021 ALOSETRON HYDROCHLORIDE
ANDA #200652		 SUPPL-7 ALOSETRON HYDROCHLORIDE HIKMA REMS Approval
10/18/2021 OXYBUTYNIN CHLORIDE
ANDA #202332		 SUPPL-7 OXYBUTYNIN CHLORIDE ZYDUS PHARMS Labeling Approval
10/18/2021 BUTALBITAL, ASPIRIN AND CAFFEINE
ANDA #205230		 ORIG-1 ASPIRIN; BUTALBITAL; CAFFEINE LGM PHARMA Approval
10/18/2021 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205588		 SUPPL-8 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN LTD Manufacturing (CMC) Approval
10/18/2021 EVEROLIMUS
ANDA #205775		 ORIG-1 EVEROLIMUS PAR PHARM Approval
10/18/2021 ALOSETRON HYDROCHLORIDE
ANDA #206113		 SUPPL-4 ALOSETRON HYDROCHLORIDE PAR PHARM INC REMS Approval
10/18/2021 ALOSETRON HYDROCHLORIDE
ANDA #206647		 SUPPL-9 ALOSETRON HYDROCHLORIDE AMNEAL PHARMS REMS Approval
10/18/2021 ALOSETRON HYDROCHLORIDE
ANDA #209180		 SUPPL-4 ALOSETRON HYDROCHLORIDE RISING REMS Approval
10/18/2021 ALOSETRON HYDROCHLORIDE
ANDA #213614		 SUPPL-10 ALOSETRON HYDROCHLORIDE MANKIND PHARMA REMS Approval
10/18/2021 CARBON DIOXIDE, USP
NDA #216614		 ORIG-1 CARBON DIOXIDE MIDDLESEX GASES TECHNOLOGIES, INC. Approval
10/19/2021 RELENZA
NDA #021036		 SUPPL-32 ZANAMIVIR GLAXOSMITHKLINE Labeling Approval
10/19/2021 TAZICEF
ANDA #062662		 SUPPL-32 CEFTAZIDIME HOSPIRA Labeling Approval
10/19/2021 TAZICEF
ANDA #062662		 SUPPL-37 CEFTAZIDIME HOSPIRA Labeling Approval
10/19/2021 FUROSEMIDE
ANDA #077941		 SUPPL-1 FUROSEMIDE WOCKHARDT Labeling Approval
10/19/2021 MINIVELLE
NDA #203752		 SUPPL-12 ESTRADIOL NOVEN Labeling Approval
10/19/2021 MINIVELLE
NDA #203752		 SUPPL-13 ESTRADIOL NOVEN Labeling Approval
10/19/2021 LOKELMA
NDA #207078		 SUPPL-7 SODIUM ZIRCONIUM CYCLOSILICATE ASTRAZENECA Labeling Approval
10/19/2021 CHOLESTYRAMINE LIGHT
ANDA #211799		 ORIG-1 CHOLESTYRAMINE ALKEM LABS LTD Approval
10/19/2021 MIDAZOLAM IN 0.9% SODIUM CHLORIDE
NDA #211844		 SUPPL-1 MIDAZOLAM INFORLIFE Labeling Approval
10/19/2021 CHOLESTYRAMINE
ANDA #211856		 ORIG-1 CHOLESTYRAMINE ALKEM LABS LTD Approval
10/19/2021 DICLOFENAC POTASSIUM
ANDA #213875		 ORIG-1 DICLOFENAC POTASSIUM AUROBINDO PHARMA LTD Approval
10/19/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #214514		 ORIG-1 SUCCINYLCHOLINE CHLORIDE MEITHEAL Approval
10/20/2021 SANDOSTATIN
NDA #019667		 SUPPL-71 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
10/20/2021 ZOFRAN
NDA #020007		 SUPPL-49 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/20/2021 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-49 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/20/2021 ZOFRAN
NDA #020103		 SUPPL-38 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/20/2021 SABRIL
NDA #020427		 SUPPL-25 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/20/2021 ZOFRAN
NDA #020605		 SUPPL-22 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/20/2021 ZOFRAN ODT
NDA #020781		 SUPPL-22 ONDANSETRON SANDOZ Labeling Approval
10/20/2021 WELCHOL
NDA #021176		 SUPPL-49 COLESEVELAM HYDROCHLORIDE COSETTE Labeling Approval
10/20/2021 SABRIL
NDA #022006		 SUPPL-26 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/20/2021 WELCHOL
NDA #022362		 SUPPL-29 COLESEVELAM HYDROCHLORIDE COSETTE Efficacy Approval
10/20/2021 METHIMAZOLE
ANDA #040350		 SUPPL-24 METHIMAZOLE MYLAN Labeling Approval
10/20/2021 HYDROXYCHLOROQUINE SULFATE
ANDA #040760		 SUPPL-8 HYDROXYCHLOROQUINE SULFATE HIKMA PHARMS Labeling Approval
10/20/2021 CEFTAZIDIME IN DEXTROSE CONTAINER
NDA #050823		 SUPPL-9 CEFTAZIDIME B BRAUN Labeling Approval
10/20/2021 TIZANIDINE HYDROCHLORIDE
ANDA #091502		 SUPPL-3 TIZANIDINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
10/20/2021 METHIMAZOLE
ANDA #202068		 SUPPL-5 METHIMAZOLE RISING Labeling Approval
10/20/2021 ZOLMITRIPTAN
ANDA #203186		 SUPPL-3 ZOLMITRIPTAN NATCO PHARMA USA Labeling Approval
10/20/2021 CLOBAZAM
ANDA #209796		 SUPPL-1 CLOBAZAM HETERO LABS LTD III Labeling Approval
10/20/2021 SUNOSI
NDA #211230		 SUPPL-4 SOLRIAMFETOL HYDROCHLORIDE AXSOME MALTA Labeling Approval
10/20/2021 CARISOPRODOL
ANDA #211789		 ORIG-1 CARISOPRODOL MLV Approval
10/20/2021 TURALIO
NDA #211810		 SUPPL-7 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC Labeling Approval
10/20/2021 POTASSIUM ACETATE
ANDA #212692		 ORIG-1 POTASSIUM ACETATE EXELA PHARMA Approval
10/20/2021 FLUPHENAZINE HYDROCHLORIDE
ANDA #215141		 ORIG-1 FLUPHENAZINE HYDROCHLORIDE ZAMEER PHARMS Approval
10/20/2021 MITOMYCIN
ANDA #215687		 ORIG-1 MITOMYCIN GLAND PHARMA LTD Approval
10/20/2021 DUPIXENT
BLA #761055		 SUPPL-31 DUPILUMAB REGENERON PHARMACEUTICALS Approval
10/21/2021 HIBICLENS
NDA #017768		 SUPPL-55 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Manufacturing (CMC) Approval
10/21/2021 MIDOL LIQUID GELS
NDA #021472		 SUPPL-15 IBUPROFEN BIONPHARMA Labeling Approval
10/21/2021 OMEPRAZOLE
NDA #022032		 SUPPL-52 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
10/21/2021 RIFADIN
NDA #050420		 SUPPL-86 RIFAMPIN SANOFI AVENTIS US Labeling Approval
10/21/2021 RIFADIN
NDA #050627		 SUPPL-29 RIFAMPIN SANOFI AVENTIS US Labeling Approval
10/21/2021 RIFATER
NDA #050705		 SUPPL-20 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
10/21/2021 DEFERIPRONE
ANDA #213239		 SUPPL-3 DEFERIPRONE HIKMA Labeling Approval
10/21/2021 FOSFOMYCIN TROMETHAMINE
ANDA #214554		 ORIG-1 FOSFOMYCIN TROMETHAMINE ALKEM LABS LTD Approval
10/22/2021 NOVOLOG
BLA #020986		 SUPPL-95 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/22/2021 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-95 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/22/2021 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-95 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/22/2021 NOVOLOG INNOLET
BLA #020986		 SUPPL-95 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/22/2021 NOVOLOG PENFILL
BLA #020986		 SUPPL-95 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/22/2021 CELLCEPT
NDA #050722		 SUPPL-45 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050722		 SUPPL-46 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050723		 SUPPL-45 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050723		 SUPPL-46 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050758		 SUPPL-42 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050758		 SUPPL-43 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050759		 SUPPL-50 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 CELLCEPT
NDA #050759		 SUPPL-51 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
10/22/2021 DILANTIN
ANDA #084349		 SUPPL-87 PHENYTOIN SODIUM VIATRIS Labeling Approval
10/22/2021 DILANTIN
ANDA #084427		 SUPPL-44 PHENYTOIN PHARMACIA Labeling Approval
10/22/2021 ACTEMRA
BLA #125276		 SUPPL-135 TOCILIZUMAB GENENTECH Approval
10/22/2021 ACTEMRA
BLA #125472		 SUPPL-45 TOCILIZUMAB GENENTECH Approval
10/22/2021 VENCLEXTA
NDA #208573		 SUPPL-26 VENETOCLAX ABBVIE Labeling Approval
10/22/2021 XIPERE
NDA #211950		 ORIG-1 TRIAMCINOLONE ACETONIDE BAUSCH AND LOMB INC Type 3 - New Dosage Form Approval
10/22/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #215579		 ORIG-1 LOPERAMIDE HYDROCHLORIDE BIONPHARMA Approval
10/22/2021 SUSVIMO
BLA #761197		 ORIG-1 RANIBIZUMAB GENENTECH INC Approval
10/25/2021 FORANE
NDA #017624		 SUPPL-40 ISOFLURANE BAXTER HLTHCARE Labeling Approval
10/25/2021 DIFLUCAN
NDA #019949		 SUPPL-70 FLUCONAZOLE PFIZER Labeling Approval
10/25/2021 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-69 FLUCONAZOLE PFIZER Labeling Approval
10/25/2021 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-69 FLUCONAZOLE PFIZER Labeling Approval
10/25/2021 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-69 FLUCONAZOLE PFIZER Labeling Approval
10/25/2021 DIFLUCAN
NDA #020090		 SUPPL-51 FLUCONAZOLE PFIZER Labeling Approval
10/25/2021 CANCIDAS
NDA #021227		 SUPPL-40 CASPOFUNGIN ACETATE MERCK Labeling Approval
10/25/2021 VELCADE
NDA #021602		 SUPPL-45 BORTEZOMIB TAKEDA PHARMS USA Labeling Approval
10/25/2021 ZYLET
NDA #050804		 SUPPL-26 LOTEPREDNOL ETABONATE; TOBRAMYCIN BAUSCH AND LOMB Labeling Approval
10/25/2021 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #077612		 SUPPL-6 SULFAMETHOXAZOLE; TRIMETHOPRIM PRASCO Manufacturing (CMC) Approval
10/25/2021 METOPROLOL TARTRATE
ANDA #078085		 SUPPL-13 METOPROLOL TARTRATE HOSPIRA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089340		 SUPPL-36 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089340		 SUPPL-39 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089340		 SUPPL-41 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089341		 SUPPL-34 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089341		 SUPPL-36 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089341		 SUPPL-38 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089342		 SUPPL-34 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089342		 SUPPL-36 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM
ANDA #089342		 SUPPL-38 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089343		 SUPPL-34 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089343		 SUPPL-36 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089343		 SUPPL-38 METHOTREXATE SODIUM HIKMA Labeling Approval
10/25/2021 VINBLASTINE SULFATE
ANDA #089515		 SUPPL-38 VINBLASTINE SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090029		 SUPPL-12 METHOTREXATE SODIUM SANDOZ Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090029		 SUPPL-13 METHOTREXATE SODIUM SANDOZ Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090039		 SUPPL-13 METHOTREXATE SODIUM SANDOZ Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090039		 SUPPL-14 METHOTREXATE SODIUM SANDOZ Labeling Approval
10/25/2021 OPSUMIT
NDA #204410		 SUPPL-22 MACITENTAN ACTELION Labeling Approval
10/25/2021 PATADAY ONCE DAILY RELIEF
NDA #206276		 SUPPL-6 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Manufacturing (CMC) Approval
10/25/2021 OXYCODONE HYDROCHLORIDE
ANDA #207418		 SUPPL-4 OXYCODONE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
10/25/2021 OXYCODONE HYDROCHLORIDE
ANDA #207418		 SUPPL-5 OXYCODONE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
10/25/2021 EPLERENONE
ANDA #207842		 ORIG-1 EPLERENONE WESTMINSTER PHARMS Approval
10/25/2021 UPTRAVI
NDA #207947		 SUPPL-9 SELEXIPAG ACTELION Labeling Approval
10/25/2021 LURASIDONE HYDROCHLORIDE
ANDA #208058		 SUPPL-1 LURASIDONE HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
10/25/2021 CLOBAZAM
ANDA #209808		 SUPPL-1 CLOBAZAM PIRAMAL HLTHCARE UK Labeling Approval
10/25/2021 CLOBAZAM
ANDA #209853		 SUPPL-1 CLOBAZAM APOTEX Labeling Approval
10/25/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #210698		 SUPPL-7 SUCCINYLCHOLINE CHLORIDE DR REDDYS Labeling Approval
10/25/2021 HEPARIN SODIUM
ANDA #211004		 SUPPL-4 HEPARIN SODIUM NANJING KING-FRIEND Labeling Approval
10/25/2021 HEPARIN SODIUM
ANDA #211005		 SUPPL-4 HEPARIN SODIUM NANJING KING-FRIEND Labeling Approval
10/25/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #213705		 SUPPL-4 SUCCINYLCHOLINE CHLORIDE ACCORD HLTHCARE Labeling Approval
10/25/2021 ATOVAQUONE
ANDA #214272		 ORIG-1 ATOVAQUONE ABON PHARMS LLC Approval
10/25/2021 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #215555		 ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE AMNEAL Approval
10/25/2021 ATENOLOL AND CHLORTHALIDONE
ANDA #215560		 ORIG-1 ATENOLOL; CHLORTHALIDONE NOVITIUM PHARMA Approval
10/25/2021 CHLORPROMAZINE HYDROCHLORIDE
ANDA #215659		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE TEVA PHARMS Approval
10/26/2021 ZYVOX
NDA #021130		 SUPPL-43 LINEZOLID PFIZER Labeling Approval
10/26/2021 ZYVOX
NDA #021131		 SUPPL-39 LINEZOLID PFIZER Labeling Approval
10/26/2021 ZYVOX
NDA #021132		 SUPPL-42 LINEZOLID PFIZER Labeling Approval
10/26/2021 CUBICIN
NDA #021572		 SUPPL-65 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
10/26/2021 CUBICIN
NDA #021572		 SUPPL-66 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
10/26/2021 CUBICIN RF
NDA #021572		 SUPPL-65 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
10/26/2021 CUBICIN RF
NDA #021572		 SUPPL-66 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
10/26/2021 RIFAMPIN
ANDA #204101		 SUPPL-10 RIFAMPIN AVET LIFESCIENCES Labeling Approval
10/26/2021 PIPERACILLIN AND TAZOBACTAM
ANDA #207146		 SUPPL-6 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WOCKHARDT BIO AG Labeling Approval
10/26/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #211625		 SUPPL-1 SUCCINYLCHOLINE CHLORIDE NIVAGEN PHARMS INC Labeling Approval
10/26/2021 TEPEZZA
BLA #761143		 SUPPL-14 TEPROTUMUMAB-TRBW HORIZON THERAPEUTICS IRELAND Approval
10/27/2021 SOLU-MEDROL
NDA #011856		 SUPPL-139 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
10/27/2021 HALCION
NDA #017892		 SUPPL-56 TRIAZOLAM PFIZER Labeling Approval
10/27/2021 ADASUVE
NDA #022549		 SUPPL-9 LOXAPINE ALEXZA PHARMS Labeling Approval
10/27/2021 METHOTREXATE SODIUM
ANDA #040263		 SUPPL-14 METHOTREXATE SODIUM FRESENIUS KABI USA Labeling Approval
10/27/2021 METHOTREXATE SODIUM
ANDA #040263		 SUPPL-18 METHOTREXATE SODIUM FRESENIUS KABI USA Labeling Approval
10/27/2021 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #091392		 SUPPL-6 METOCLOPRAMIDE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/27/2021 VALSARTAN
ANDA #204038		 ORIG-1 VALSARTAN SCIEGEN PHARMS INC Approval
10/28/2021 PHOSPHOLINE IODIDE
NDA #011963		 SUPPL-52 ECHOTHIOPHATE IODIDE FERA PHARMS LLC Labeling Approval
10/28/2021 ZARONTIN
NDA #012380		 SUPPL-37 ETHOSUXIMIDE PARKE DAVIS Labeling Approval
10/28/2021 STARLIX
NDA #021204		 SUPPL-25 NATEGLINIDE NOVARTIS Labeling Approval
10/28/2021 OXYCONTIN
NDA #022272		 SUPPL-47 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Labeling Approval
10/28/2021 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202867		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE LUPIN LTD Labeling Approval
10/28/2021 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202867		 SUPPL-8 MOXIFLOXACIN HYDROCHLORIDE LUPIN LTD Labeling Approval
10/28/2021 ALBUTEROL SULFATE
ANDA #209959		 SUPPL-10 ALBUTEROL SULFATE CIPLA Labeling Approval
10/28/2021 GIVLAARI
NDA #212194		 SUPPL-4 GIVOSIRAN SODIUM ALNYLAM PHARMS INC Labeling Approval
10/28/2021 PONVORY
NDA #213498		 SUPPL-1 PONESIMOD JANSSEN PHARMS Labeling Approval
10/28/2021 VUITY
NDA #214028		 ORIG-1 PILOCARPINE HYDROCHLORIDE ABBVIE Type 5 - New Formulation or New Manufacturer Approval
10/28/2021 DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
NDA #215252		 ORIG-1 DILTIAZEM HYDROCHLORIDE EXELA PHARMA Type 5 - New Formulation or New Manufacturer Approval
10/29/2021 ACTHAR GEL
NDA #008372		 SUPPL-71 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
10/29/2021 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-71 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
10/29/2021 PURIFIED CORTROPHIN GEL
NDA #008975		 SUPPL-8 CORTICOTROPIN ANI PHARMS Manufacturing (CMC) Approval
10/29/2021 LAMOTRIGINE
ANDA #078625		 SUPPL-14 LAMOTRIGINE RUBICON Labeling Approval
10/29/2021 ZARONTIN
ANDA #080258		 SUPPL-32 ETHOSUXIMIDE PARKE-DAVIS Labeling Approval
10/29/2021 ZARONTIN
ANDA #080258		 SUPPL-35 ETHOSUXIMIDE PARKE-DAVIS Labeling Approval
10/29/2021 IBUPROFEN AND FAMOTIDINE
ANDA #211278		 ORIG-1 FAMOTIDINE; IBUPROFEN TEVA PHARMS USA Approval
10/29/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #214308		 SUPPL-4 SUCCINYLCHOLINE CHLORIDE INDOCO Labeling Approval
10/29/2021 SCEMBLIX
NDA #215358		 ORIG-1 ASCIMINIB HYDROCHLORIDE NOVARTIS Type 1 - New Molecular Entity Approval
10/29/2021 SCEMBLIX
NDA #215358		 ORIG-2 ASCIMINIB HYDROCHLORIDE NOVARTIS Type 1 - New Molecular Entity Approval
10/29/2021 BISOPROLOL FUMARATE
ANDA #215563		 ORIG-1 BISOPROLOL FUMARATE NOVITIUM PHARMA Approval
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