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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 August 19, 2022.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2021 RISPERIDONE
ANDA #076288
SUPPL-20 RISPERIDONE MYLAN 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 UBI 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 NOVARTIS Labeling Approval
10/04/2021 ESTRADIOL
NDA #020538
SUPPL-39 ESTRADIOL NOVARTIS Labeling Approval
10/04/2021 VIVELLE-DOT
NDA #020538
SUPPL-37 ESTRADIOL NOVARTIS Labeling Approval
10/04/2021 VIVELLE-DOT
NDA #020538
SUPPL-39 ESTRADIOL NOVARTIS Labeling Approval
10/04/2021 VENCLEXTA
NDA #208573
SUPPL-24 VENETOCLAX ABBVIE INC 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 PHARMS 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 BREXPIPRAZOLE
ANDA #213512
ORIG-1 BREXPIPRAZOLE LUPIN LTD Tentative 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 GENERICS 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 PHARMS 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 BREXPIPRAZOLE
ANDA #213758
ORIG-1 BREXPIPRAZOLE OPTIMUS PHARMA PRIVATE LTD Tentative 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 DOUGLAS PHARMS 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 RICONPHARMA LLC 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 EMCURE PHARMS LTD Approval
10/12/2021 DOXORUBICIN HYDROCHLORIDE
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 LENALIDOMIDE
ANDA #209348
ORIG-2 LENALIDOMIDE DR REDDYS Tentative 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 TASCENSO ODT
NDA #214962
ORIG-1 FINGOLIMOD LAURYL SULFATE HANDA Type 2 - New Active Ingredient Tentative 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 NOVARTIS Labeling Approval
10/20/2021 ZOFRAN PRESERVATIVE FREE
NDA #020007
SUPPL-49 ONDANSETRON HYDROCHLORIDE NOVARTIS Labeling Approval
10/20/2021 ZOFRAN
NDA #020103
SUPPL-38 ONDANSETRON HYDROCHLORIDE NOVARTIS 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 NOVARTIS Labeling Approval
10/20/2021 ZOFRAN ODT
NDA #020781
SUPPL-22 ONDANSETRON NOVARTIS 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 MYLAN PHARMS INC 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 ENALTEC 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 INC Labeling 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 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 INC 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 INC 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 INC Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090029
SUPPL-13 METHOTREXATE SODIUM SANDOZ INC Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090039
SUPPL-13 METHOTREXATE SODIUM SANDOZ INC Labeling Approval
10/25/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #090039
SUPPL-14 METHOTREXATE SODIUM SANDOZ INC 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 EMCURE PHARMS LTD 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 EMCURE PHARMS LTD 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 PLERIXAFOR
ANDA #215334
ORIG-1 PLERIXAFOR AMNEAL EU LTD Tentative 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 INC 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 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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