Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 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 October 24, 2021.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/02/2021 ARTHROTEC
NDA #020607
SUPPL-39 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
08/02/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040843
SUPPL-7 METHOTREXATE SODIUM PHARMACHEMIE BV Labeling Approval
08/02/2021 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #040843
SUPPL-11 METHOTREXATE SODIUM PHARMACHEMIE BV Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071134
SUPPL-32 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071134
SUPPL-35 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071135
SUPPL-35 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071135
SUPPL-38 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071136
SUPPL-36 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 DIAZEPAM
ANDA #071136
SUPPL-39 DIAZEPAM MAYNE PHARMA Labeling Approval
08/02/2021 ESTAZOLAM
ANDA #074826
SUPPL-20 ESTAZOLAM NOVITIUM PHARMA Manufacturing (CMC) Approval
08/02/2021 TOLTERODINE TARTRATE
ANDA #204397
ORIG-1 TOLTERODINE TARTRATE HETERO LABS LTD V Approval
08/02/2021 AKOVAZ
NDA #208289
SUPPL-6 EPHEDRINE SULFATE EXELA PHARMA Manufacturing (CMC) Approval
08/02/2021 ORIAHNN (COPACKAGED)
NDA #213388
SUPPL-1 ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM ABBVIE INC Labeling Approval
08/02/2021 CARMUSTINE
ANDA #213460
ORIG-1 CARMUSTINE MEITHEAL Approval
08/02/2021 DEFERASIROX
ANDA #214194
SUPPL-1 DEFERASIROX AMNEAL Manufacturing (CMC) Approval
08/03/2021 GLUCOTROL XL
NDA #020329
SUPPL-35 GLIPIZIDE PFIZER Manufacturing (CMC) Approval
08/03/2021 RAZADYNE
NDA #021169
SUPPL-35 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
08/03/2021 RAZADYNE ER
NDA #021615
SUPPL-26 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
08/03/2021 IRBESARTAN
ANDA #090201
SUPPL-7 IRBESARTAN HIKMA PHARMS Labeling Approval
08/03/2021 KEYTRUDA
BLA #125514
SUPPL-104 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/03/2021 ESCITALOPRAM OXALATE
ANDA #202221
SUPPL-2 ESCITALOPRAM OXALATE HETERO LABS LTD III Labeling Approval
08/03/2021 ESCITALOPRAM OXALATE
ANDA #202221
SUPPL-4 ESCITALOPRAM OXALATE HETERO LABS LTD III Labeling Approval
08/03/2021 ESCITALOPRAM OXALATE
ANDA #202221
SUPPL-5 ESCITALOPRAM OXALATE HETERO LABS LTD III Manufacturing (CMC) Approval
08/03/2021 BUPRENORPHINE HYDROCHLORIDE
ANDA #211594
ORIG-1 BUPRENORPHINE HYDROCHLORIDE ALVOGEN Approval
08/03/2021 IBUPROFEN AND FAMOTIDINE
ANDA #211890
ORIG-1 FAMOTIDINE; IBUPROFEN ALKEM LABS LTD Approval
08/03/2021 NICOTINE POLACRILEX
ANDA #213266
ORIG-1 NICOTINE POLACRILEX AUROBINDO PHARMA LTD Approval
08/03/2021 METFORMIN HYDROCHLORIDE
ANDA #213394
ORIG-1 METFORMIN HYDROCHLORIDE AMTA Approval
08/03/2021 TEMBEXA
NDA #214460
SUPPL-1 BRINCIDOFOVIR CHIMERIX Labeling Approval
08/03/2021 TEMBEXA
NDA #214461
SUPPL-1 BRINCIDOFOVIR CHIMERIX Labeling Approval
08/04/2021 CEFACLOR
ANDA #064148
SUPPL-6 CEFACLOR HERITAGE PHARMA Labeling Approval
08/04/2021 CEFACLOR
ANDA #064148
SUPPL-7 CEFACLOR HERITAGE PHARMA Labeling Approval
08/04/2021 MIRTAZAPINE
ANDA #076219
SUPPL-26 MIRTAZAPINE UPSHER SMITH LABS Labeling Approval
08/04/2021 MIRTAZAPINE
ANDA #076219
SUPPL-27 MIRTAZAPINE UPSHER SMITH LABS Labeling Approval
08/04/2021 MUPIROCIN
ANDA #090480
SUPPL-5 MUPIROCIN GLENMARK PHARMS Labeling Approval
08/04/2021 MUPIROCIN
ANDA #090480
SUPPL-6 MUPIROCIN GLENMARK PHARMS Labeling Approval
08/04/2021 MORPHINE SULFATE
ANDA #203158
ORIG-1 MORPHINE SULFATE NORTEC DEV ASSOC Approval
08/04/2021 INJECTAFER
NDA #203565
SUPPL-17 FERRIC CARBOXYMALTOSE AM REGENT Labeling Approval
08/04/2021 DOCETAXEL
NDA #205934
SUPPL-5 DOCETAXEL SHILPA Labeling Approval
08/04/2021 CORLANOR
NDA #206143
SUPPL-8 IVABRADINE HYDROCHLORIDE AMGEN INC Labeling Approval
08/04/2021 CORLANOR
NDA #209964
SUPPL-2 IVABRADINE AMGEN INC Labeling Approval
08/04/2021 CLOMIPRAMINE HYDROCHLORIDE
ANDA #211822
ORIG-1 CLOMIPRAMINE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
08/04/2021 RAMELTEON
ANDA #213186
SUPPL-2 RAMELTEON GRANULES Labeling Approval
08/04/2021 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #215654
ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE GLAND PHARMA LTD Approval
08/05/2021 DROXIA
NDA #016295
SUPPL-55 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
08/05/2021 HYDREA
NDA #016295
SUPPL-55 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
08/05/2021 OMNIPAQUE 12
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 140
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 180
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 210
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 240
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 300
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 350
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 70
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 OMNIPAQUE 9
NDA #018956
SUPPL-112 IOHEXOL GE HEALTHCARE Labeling Approval
08/05/2021 THALOMID
NDA #020785
SUPPL-70 THALIDOMIDE CELGENE REMS Approval
08/05/2021 REVLIMID
NDA #021880
SUPPL-63 LENALIDOMIDE CELGENE REMS Approval
08/05/2021 QUTENZA
NDA #022395
SUPPL-20 CAPSAICIN AVERITAS Labeling Approval
08/05/2021 ZUPLENZ
NDA #022524
SUPPL-7 ONDANSETRON AQUESTIVE Labeling Approval
08/05/2021 CARBAGLU
NDA #022562
SUPPL-13 CARGLUMIC ACID RECORDATI RARE Labeling Approval
08/05/2021 ENALAPRIL MALEATE
ANDA #075479
SUPPL-36 ENALAPRIL MALEATE HERITAGE PHARMA Labeling Approval
08/05/2021 ENALAPRIL MALEATE
ANDA #075479
SUPPL-37 ENALAPRIL MALEATE HERITAGE PHARMA Labeling Approval
08/05/2021 ENALAPRIL MALEATE
ANDA #075479
SUPPL-40 ENALAPRIL MALEATE HERITAGE PHARMA Labeling Approval
08/05/2021 ENALAPRIL MALEATE
ANDA #075479
SUPPL-42 ENALAPRIL MALEATE HERITAGE PHARMA Manufacturing (CMC) Approval
08/05/2021 LENALIDOMIDE
ANDA #201452
SUPPL-1 LENALIDOMIDE ARROW INTL REMS Approval
08/05/2021 POMALYST
NDA #204026
SUPPL-29 POMALIDOMIDE CELGENE REMS Approval
08/05/2021 ACYCLOVIR
ANDA #212444
SUPPL-1 ACYCLOVIR MACLEODS PHARMS LTD Manufacturing (CMC) Approval
08/06/2021 TRI-LEGEST FE
ANDA #076105
SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/06/2021 TRI-LEGEST FE
ANDA #076105
SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/06/2021 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #076629
SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MAYNE PHARMA Labeling Approval
08/06/2021 XADAGO
NDA #207145
SUPPL-6 SAFINAMIDE MESYLATE MDD US Labeling Approval
08/06/2021 ENSTILAR
NDA #207589
SUPPL-11 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
08/06/2021 VENLAFAXINE HYDROCHLORIDE
ANDA #214654
ORIG-1 VENLAFAXINE HYDROCHLORIDE YICHANG HUMANWELL Approval
08/06/2021 NEXVIAZYME
BLA #761194
ORIG-1 AVALGLUCOSIDASE ALFA-NGPT GENZYME CORP Approval
08/09/2021 RAPAMUNE
NDA #021110
SUPPL-86 SIROLIMUS PF PRISM CV Labeling Approval
08/09/2021 INVEGA SUSTENNA
NDA #022264
SUPPL-33 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
08/09/2021 TERBINAFINE HYDROCHLORIDE
ANDA #077137
SUPPL-7 TERBINAFINE HYDROCHLORIDE CIPLA Labeling Approval
08/09/2021 TERBINAFINE HYDROCHLORIDE
ANDA #077137
SUPPL-9 TERBINAFINE HYDROCHLORIDE CIPLA Labeling Approval
08/09/2021 TERBINAFINE HYDROCHLORIDE
ANDA #077137
SUPPL-11 TERBINAFINE HYDROCHLORIDE CIPLA Labeling Approval
08/09/2021 GLYCOPYRROLATE
ANDA #204438
ORIG-1 GLYCOPYRROLATE PAR PHARM INC Approval
08/09/2021 EVOMELA
NDA #207155
SUPPL-4 MELPHALAN HYDROCHLORIDE ACROTECH Labeling Approval
08/09/2021 INVEGA HAFYERA
NDA #207946
SUPPL-11 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
08/09/2021 INVEGA TRINZA
NDA #207946
SUPPL-11 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
08/09/2021 DROXIDOPA
ANDA #211726
SUPPL-1 DROXIDOPA ANNORA Manufacturing (CMC) Approval
08/09/2021 DIFLUPREDNATE
ANDA #211776
ORIG-1 DIFLUPREDNATE CIPLA Approval
08/09/2021 MEMANTINE HYDROCHLORIDE
ANDA #214651
ORIG-1 MEMANTINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/10/2021 ACTIVELLA
NDA #020907
SUPPL-20 ESTRADIOL; NORETHINDRONE ACETATE AMNEAL Labeling Approval
08/10/2021 ACTIVELLA
NDA #020907
SUPPL-22 ESTRADIOL; NORETHINDRONE ACETATE AMNEAL Labeling Approval
08/10/2021 TAMIFLU
NDA #021246
SUPPL-55 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
08/10/2021 BRILINTA
NDA #022433
SUPPL-32 TICAGRELOR ASTRAZENECA Labeling Approval
08/10/2021 KEYTRUDA
BLA #125514
SUPPL-102 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/10/2021 LACOSAMIDE
ANDA #204857
ORIG-1 LACOSAMIDE AMNEAL PHARMS NY Tentative Approval
08/10/2021 LENVIMA
NDA #206947
SUPPL-19 LENVATINIB MESYLATE EISAI INC Efficacy Approval
08/10/2021 VORICONAZOLE
ANDA #211661
SUPPL-1 VORICONAZOLE HAINAN POLY PHARM Labeling Approval
08/10/2021 VORICONAZOLE
ANDA #211661
SUPPL-3 VORICONAZOLE HAINAN POLY PHARM Labeling Approval
08/10/2021 VORICONAZOLE
ANDA #211661
SUPPL-8 VORICONAZOLE HAINAN POLY PHARM Labeling Approval
08/10/2021 VORICONAZOLE
ANDA #211661
SUPPL-9 VORICONAZOLE HAINAN POLY PHARM Labeling Approval
08/10/2021 DIAZEPAM
ANDA #211998
SUPPL-6 DIAZEPAM BELOTECA INC Labeling Approval
08/10/2021 ENALAPRIL MALEATE
ANDA #212408
ORIG-1 ENALAPRIL MALEATE BIONPHARMA INC Approval
08/10/2021 BORTEZOMIB
ANDA #212825
ORIG-1 BORTEZOMIB EUGIA PHARMA Tentative Approval
08/10/2021 NYSTATIN
ANDA #213566
ORIG-1 NYSTATIN MACLEODS PHARMS LTD Approval
08/11/2021 QUELICIN
NDA #008845
SUPPL-76 SUCCINYLCHOLINE CHLORIDE HOSPIRA Labeling Approval
08/11/2021 QUELICIN PRESERVATIVE FREE
NDA #008845
SUPPL-76 SUCCINYLCHOLINE CHLORIDE HOSPIRA Labeling Approval
08/11/2021 MIRENA
NDA #021225
SUPPL-42 LEVONORGESTREL BAYER HLTHCARE Efficacy Approval
08/11/2021 MOXEZA
NDA #022428
SUPPL-10 MOXIFLOXACIN HYDROCHLORIDE NOVARTIS Labeling Approval
08/11/2021 MAXIPIME
NDA #050679
SUPPL-46 CEFEPIME HYDROCHLORIDE HOSPIRA INC Labeling Approval
08/11/2021 CELLCEPT
NDA #050722
SUPPL-48 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
08/11/2021 CELLCEPT
NDA #050723
SUPPL-48 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
08/11/2021 CELLCEPT
NDA #050758
SUPPL-45 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO REMS Approval
08/11/2021 CELLCEPT
NDA #050759
SUPPL-53 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
08/11/2021 MYFORTIC
NDA #050791
SUPPL-36 MYCOPHENOLIC ACID NOVARTIS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065379
SUPPL-30 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065410
SUPPL-19 MYCOPHENOLATE MOFETIL HIKMA PHARMS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065413
SUPPL-20 MYCOPHENOLATE MOFETIL HIKMA PHARMS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065416
SUPPL-21 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065451
SUPPL-30 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065457
SUPPL-17 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065491
SUPPL-23 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065520
SUPPL-30 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #065521
SUPPL-28 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090055
SUPPL-21 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090111
SUPPL-12 MYCOPHENOLATE MOFETIL VINTAGE PHARMS LLC REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090253
SUPPL-21 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090456
SUPPL-24 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090606
SUPPL-11 MYCOPHENOLATE MOFETIL AMNEAL REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090661
SUPPL-10 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #090762
SUPPL-10 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #091248
SUPPL-17 MYCOPHENOLIC ACID RK PHARMA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #091249
SUPPL-24 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #091558
SUPPL-18 MYCOPHENOLIC ACID APOTEX INC REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #200197
SUPPL-21 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
08/11/2021 VARENICLINE TARTRATE
ANDA #201785
ORIG-1 VARENICLINE TARTRATE PAR PHARM INC Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #202555
SUPPL-6 MYCOPHENOLIC ACID ACCORD HLTHCARE REMS Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #202720
SUPPL-9 MYCOPHENOLIC ACID TEVA PHARMS USA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #203005
SUPPL-17 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203575
SUPPL-7 MYCOPHENOLATE MOFETIL HYDROCHLORIDE PAR STERILE PRODUCTS REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203859
SUPPL-9 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYLAN LABS LTD REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043
SUPPL-11 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AKORN REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #204076
SUPPL-4 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #204077
SUPPL-4 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204473
SUPPL-6 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ZYDUS PHARMS REMS Approval
08/11/2021 ASPIRIN AND DIPYRIDAMOLE
ANDA #209929
ORIG-1 ASPIRIN; DIPYRIDAMOLE MICRO LABS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #210181
SUPPL-9 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #210370
SUPPL-9 MYCOPHENOLATE MOFETIL VISTAPHARM REMS Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #211173
SUPPL-7 MYCOPHENOLIC ACID CONCORD BIOTECH LTD REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #211374
SUPPL-2 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AMNEAL REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #212087
SUPPL-4 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #212130
SUPPL-3 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MEITHEAL REMS Approval
08/11/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #213070
ORIG-1 LOPERAMIDE HYDROCHLORIDE STRIDES PHARMA Approval
08/11/2021 METFORMIN HYDROCHLORIDE
ANDA #213359
ORIG-1 METFORMIN HYDROCHLORIDE UNICHEM Approval
08/11/2021 PAROXETINE HYDROCHLORIDE
ANDA #213612
ORIG-1 PAROXETINE HYDROCHLORIDE SINOTHERAPEUTICS INC Approval
08/11/2021 MYCOPHENOLIC ACID
ANDA #214376
SUPPL-3 MYCOPHENOLIC ACID AMTA REMS Approval
08/11/2021 MYCOPHENOLATE MOFETIL
ANDA #214525
SUPPL-1 MYCOPHENOLATE MOFETIL LANNETT CO INC REMS Approval
08/12/2021 XYREM
NDA #021196
SUPPL-36 SODIUM OXYBATE JAZZ PHARMS REMS Approval
08/12/2021 COLCHICINE
ANDA #203976
ORIG-1 COLCHICINE PAR PHARM INC Approval
08/12/2021 LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473
SUPPL-4 LINEZOLID HOSPIRA INC Labeling Approval
08/12/2021 METHYLNALTREXONE BROMIDE
ANDA #208038
ORIG-1 METHYLNALTREXONE BROMIDE US GENERICS, STERILES Tentative Approval
08/12/2021 MESALAMINE
ANDA #208954
ORIG-1 MESALAMINE ZYDUS PHARMS Approval
08/12/2021 XYWAV
NDA #212690
SUPPL-6 CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE JAZZ Efficacy Approval
08/13/2021 ARIDOL
NDA #022368
SUPPL-3 MANNITOL PHARMAXIS LTD Labeling Approval
08/13/2021 ARIDOL KIT
NDA #022368
SUPPL-3 MANNITOL PHARMAXIS LTD Labeling Approval
08/13/2021 Xeomin
BLA #125360
SUPPL-93 incobotulinumtoxinA MERZ PHARMS Approval
08/13/2021 RILUZOLE
ANDA #204048
SUPPL-1 RILUZOLE ALKEM LABS LTD Labeling Approval
08/13/2021 RILUZOLE
ANDA #204048
SUPPL-2 RILUZOLE ALKEM LABS LTD Labeling Approval
08/13/2021 COLCHICINE
ANDA #208993
ORIG-1 COLCHICINE HETERO LABS LTD V Approval
08/13/2021 TRIENTINE HYDROCHLORIDE
ANDA #209945
ORIG-1 TRIENTINE HYDROCHLORIDE PHARMA LIFE Approval
08/13/2021 CLINDAMYCIN PHOSPHATE
ANDA #212842
ORIG-1 CLINDAMYCIN PHOSPHATE SOLARIS PHARMA CORP Approval
08/13/2021 FULVESTRANT
ANDA #213553
ORIG-1 FULVESTRANT XIROMED Approval
08/13/2021 LEUPROLIDE ACETATE
ANDA #213829
ORIG-1 LEUPROLIDE ACETATE VGYAAN Approval
08/13/2021 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #214087
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE SENORES PHARMS Approval
08/13/2021 BRIVARACETAM
ANDA #214918
ORIG-1 BRIVARACETAM LUPIN LTD Tentative Approval
08/13/2021 WELIREG
NDA #215383
ORIG-1 BELZUTIFAN MERCK SHARP DOHME Type 1 - New Molecular Entity Approval
08/13/2021 PYRIMETHAMINE
ANDA #215506
ORIG-1 PYRIMETHAMINE TEVA PHARMS Approval
08/13/2021 LYUMJEV
BLA #761109
SUPPL-3 INSULIN LISPRO-AABC ELI LILLY AND CO Approval
08/16/2021 INNOPRAN XL
NDA #021438
SUPPL-25 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Labeling Approval
08/16/2021 AVEED
NDA #022219
SUPPL-15 TESTOSTERONE UNDECANOATE ENDO PHARMS INC Labeling Approval
08/16/2021 AKTOB
ANDA #064096
SUPPL-14 TOBRAMYCIN AKORN Labeling Approval
08/16/2021 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-26 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343
SUPPL-9 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343
SUPPL-10 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077365
SUPPL-10 ONDANSETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077365
SUPPL-13 ONDANSETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077368
SUPPL-8 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE
ANDA #077368
SUPPL-9 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
08/16/2021 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077375
SUPPL-13 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE MYLAN Labeling Approval
08/16/2021 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077375
SUPPL-14 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE MYLAN Labeling Approval
08/16/2021 MIRTAZAPINE
ANDA #077376
SUPPL-23 MIRTAZAPINE AUROBINDO PHARMA LTD Labeling Approval
08/16/2021 MIRTAZAPINE
ANDA #077376
SUPPL-25 MIRTAZAPINE AUROBINDO PHARMA LTD Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541
SUPPL-13 ONDANSETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/16/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541
SUPPL-21 ONDANSETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/16/2021 LACTULOSE
ANDA #203762
SUPPL-4 LACTULOSE TORRENT Manufacturing (CMC) Approval
08/16/2021 LENALIDOMIDE
ANDA #210154
ORIG-1 LENALIDOMIDE ZYDUS PHARMS USA INC Tentative Approval
08/16/2021 SUNITINIB MALATE
ANDA #213914
ORIG-1 SUNITINIB MALATE SUN PHARM Approval
08/16/2021 CARBAMAZEPINE
ANDA #214328
ORIG-1 CARBAMAZEPINE VGYAAN Approval
08/17/2021 PREZISTA
NDA #021976
SUPPL-63 DARUNAVIR JANSSEN PRODS Labeling Approval
08/17/2021 LISINOPRIL
ANDA #075903
SUPPL-21 LISINOPRIL ASCENT PHARMS INC Manufacturing (CMC) Approval
08/17/2021 ENTYVIO
BLA #125476
SUPPL-38 VEDOLIZUMAB TAKEDA PHARMS USA Approval
08/17/2021 ENTYVIO
BLA #125476
SUPPL-39 VEDOLIZUMAB TAKEDA PHARMS USA Approval
08/17/2021 PREZISTA
NDA #202895
SUPPL-32 DARUNAVIR JANSSEN PRODS Labeling Approval
08/17/2021 PIZENSY
NDA #211281
SUPPL-1 LACTITOL BRAINTREE LABS Labeling Approval
08/17/2021 BREXPIPRAZOLE
ANDA #213788
ORIG-1 BREXPIPRAZOLE ACCORD HLTHCARE INC Tentative Approval
08/17/2021 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #214751
ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE MACLEODS PHARMS LTD Approval
08/17/2021 JEMPERLI
BLA #761223
ORIG-1 DOSTARLIMAB-GXLY GLAXOSMITHKLINE LLC Approval
08/18/2021 VENTOLIN HFA
NDA #020983
SUPPL-41 ALBUTEROL SULFATE GLAXOSMITHKLINE Labeling Approval
08/18/2021 ADVAIR HFA
NDA #021254
SUPPL-36 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
08/18/2021 FLOVENT HFA
NDA #021433
SUPPL-40 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
08/18/2021 ETHOSUXIMIDE
ANDA #040686
SUPPL-12 ETHOSUXIMIDE AKORN Labeling Approval
08/18/2021 DESMOPRESSIN ACETATE
ANDA #074830
SUPPL-22 DESMOPRESSIN ACETATE BAUSCH AND LOMB Labeling Approval
08/18/2021 DESMOPRESSIN ACETATE
ANDA #074830
SUPPL-23 DESMOPRESSIN ACETATE BAUSCH AND LOMB Labeling Approval
08/18/2021 JUNEL FE 1.5/30
ANDA #076064
SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/18/2021 JUNEL FE 1/20
ANDA #076081
SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/18/2021 JUNEL 1/20
ANDA #076380
SUPPL-17 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/18/2021 JUNEL 1.5/30
ANDA #076381
SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR Labeling Approval
08/18/2021 PRAVASTATIN SODIUM
ANDA #077013
SUPPL-4 PRAVASTATIN SODIUM MYLAN Labeling Approval
08/18/2021 FAMOTIDINE
ANDA #077351
SUPPL-28 FAMOTIDINE PERRIGO R AND D Manufacturing (CMC) Approval
08/18/2021 BUPROPION HYDROCHLORIDE
ANDA #077475
SUPPL-20 BUPROPION HYDROCHLORIDE SANDOZ INC Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945
SUPPL-14 ONDANSETRON HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945
SUPPL-19 ONDANSETRON HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
08/18/2021 METRONIDAZOLE
ANDA #079067
SUPPL-17 METRONIDAZOLE ALEMBIC PHARMS LTD Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #079224
SUPPL-11 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #079224
SUPPL-17 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #090424
SUPPL-16 ONDANSETRON HYDROCHLORIDE EMCURE PHARMS Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #090424
SUPPL-18 ONDANSETRON HYDROCHLORIDE EMCURE PHARMS Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #090648
SUPPL-8 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/18/2021 ONDANSETRON HYDROCHLORIDE
ANDA #090648
SUPPL-13 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/18/2021 CAMPATH
BLA #103948
SUPPL-5183 ALEMTUZUMAB GENZYME Approval
08/18/2021 LEMTRADA
BLA #103948
SUPPL-5183 ALEMTUZUMAB GENZYME Approval
08/18/2021 JARDIANCE
NDA #204629
SUPPL-26 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Efficacy Approval
08/18/2021 BRINZOLAMIDE
ANDA #204884
ORIG-1 BRINZOLAMIDE BAUSCH Approval
08/18/2021 METRONIDAZOLE
ANDA #205245
SUPPL-8 METRONIDAZOLE HERITAGE PHARMS INC Labeling Approval
08/18/2021 LEXETTE
NDA #210566
SUPPL-3 HALOBETASOL PROPIONATE MAYNE PHARMA Efficacy Approval
08/18/2021 LABETALOL HYDROCHLORIDE
ANDA #211953
ORIG-1 LABETALOL HYDROCHLORIDE RUBICON Approval
08/18/2021 PALBOCICLIB
ANDA #213091
ORIG-1 PALBOCICLIB DR REDDYS LABS LTD Tentative Approval
08/19/2021 METRONIDAZOLE
ANDA #070039
SUPPL-14 METRONIDAZOLE STRIDES PHARMA Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #070040
SUPPL-14 METRONIDAZOLE STRIDES PHARMA Labeling Approval
08/19/2021 XIAFLEX
BLA #125338
SUPPL-117 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
08/19/2021 OPDIVO
BLA #125554
SUPPL-97 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
08/19/2021 ONDANSETRON HYDROCHLORIDE
ANDA #202599
SUPPL-6 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/19/2021 ONDANSETRON HYDROCHLORIDE
ANDA #202599
SUPPL-8 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/19/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202600
SUPPL-7 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/19/2021 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202600
SUPPL-10 ONDANSETRON HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #203458
SUPPL-12 METRONIDAZOLE UNICHEM Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #203974
SUPPL-8 METRONIDAZOLE AUROBINDO PHARMA LTD Labeling Approval
08/19/2021 ZYKADIA
NDA #205755
SUPPL-18 CERITINIB NOVARTIS Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #206560
SUPPL-3 METRONIDAZOLE CADILA Labeling Approval
08/19/2021 UPTRAVI
NDA #207947
SUPPL-10 SELEXIPAG ACTELION Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #208162
SUPPL-8 METRONIDAZOLE STRIDES PHARMA Labeling Approval
08/19/2021 METRONIDAZOLE
ANDA #209096
SUPPL-2 METRONIDAZOLE LUPIN LTD Labeling Approval
08/19/2021 ZYKADIA
NDA #211225
SUPPL-3 CERITINIB NOVARTIS Labeling Approval
08/19/2021 PENICILLAMINE
ANDA #213293
ORIG-1 PENICILLAMINE INVAGEN PHARMS Approval
08/19/2021 WINLEVI
NDA #213433
SUPPL-1 CLASCOTERONE SUN PHARM Supplement Approval
08/19/2021 TOFACITINIB
ANDA #214264
ORIG-1 TOFACITINIB CITRATE ZYDUS PHARMS Approval
08/19/2021 ACETAZOLAMIDE
ANDA #215101
ORIG-1 ACETAZOLAMIDE RUBICON Approval
08/20/2021 SOMAVERT
BLA #021106
SUPPL-67 PEGVISOMANT PHARMACIA Approval
08/20/2021 SOMAVERT
BLA #021106
SUPPL-68 PEGVISOMANT PHARMACIA Approval
08/20/2021 TESTIM
NDA #021454
SUPPL-25 TESTOSTERONE AUXILIUM PHARMS LLC Labeling Approval
08/20/2021 TESTIM
NDA #021454
SUPPL-34 TESTOSTERONE AUXILIUM PHARMS LLC Labeling Approval
08/20/2021 LIDOCAINE HYDROCHLORIDE
ANDA #088803
SUPPL-17 LIDOCAINE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/20/2021 GVOKE HYPOPEN
NDA #212097
SUPPL-7 GLUCAGON XERIS Labeling Approval
08/20/2021 GVOKE PFS
NDA #212097
SUPPL-7 GLUCAGON XERIS Labeling Approval
08/20/2021 AMANTADINE HYDROCHLORIDE
ANDA #214178
ORIG-1 AMANTADINE HYDROCHLORIDE NOVELGENIX THERAPS Approval
08/20/2021 CYANOCOBALAMIN
ANDA #215046
ORIG-1 CYANOCOBALAMIN XIROMED Approval
08/20/2021 SUCCINYLCHOLINE CHLORIDE
NDA #215143
ORIG-1 SUCCINYLCHOLINE CHLORIDE HIKMA PHARMS Type 5 - New Formulation or New Manufacturer Approval
08/20/2021 METOLAZONE
ANDA #215184
ORIG-1 METOLAZONE RUBICON Approval
08/20/2021 BORTEZOMIB
NDA #215441
ORIG-1 BORTEZOMIB INTAS PHARMS USA Type 5 - New Formulation or New Manufacturer Tentative Approval
08/23/2021 XARELTO
NDA #022406
SUPPL-37 RIVAROXABAN JANSSEN PHARMS Labeling Approval
08/23/2021 HYDROXYCHLOROQUINE SULFATE
ANDA #040104
SUPPL-35 HYDROXYCHLOROQUINE SULFATE SANDOZ Labeling Approval
08/23/2021 HYDROXYCHLOROQUINE SULFATE
ANDA #040274
SUPPL-18 HYDROXYCHLOROQUINE SULFATE MYLAN Labeling Approval
08/23/2021 HYDROXYCHLOROQUINE SULFATE
ANDA #040766
SUPPL-18 HYDROXYCHLOROQUINE SULFATE IPCA LABS LTD Labeling Approval
08/23/2021 HALOPERIDOL DECANOATE
ANDA #075393
SUPPL-36 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
08/23/2021 HALOPERIDOL DECANOATE
ANDA #075440
SUPPL-49 HALOPERIDOL DECANOATE MYLAN LABS LTD Labeling Approval
08/23/2021 LATANOPROST
ANDA #091449
SUPPL-7 LATANOPROST SANDOZ INC Labeling Approval
08/23/2021 LATANOPROST
ANDA #200925
SUPPL-6 LATANOPROST AMRING PHARMS Labeling Approval
08/23/2021 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633
SUPPL-16 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM Labeling Approval
08/23/2021 ZYTIGA
NDA #202379
SUPPL-35 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
08/23/2021 XARELTO
NDA #202439
SUPPL-35 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
08/23/2021 ACYCLOVIR SODIUM
ANDA #206535
SUPPL-4 ACYCLOVIR SODIUM ZYDUS PHARMS Labeling Approval
08/23/2021 CLOMIPRAMINE HYDROCHLORIDE
ANDA #208961
SUPPL-1 CLOMIPRAMINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
08/23/2021 BREXPIPRAZOLE
ANDA #213718
ORIG-1 BREXPIPRAZOLE AJANTA PHARMA LTD Tentative Approval
08/23/2021 KORSUVA
NDA #214916
ORIG-1 DIFELIKEFALIN ACETATE CARA THERAP Type 1 - New Molecular Entity Approval
08/23/2021 PENICILLAMINE
ANDA #215409
ORIG-1 PENICILLAMINE BRECKENRIDGE Approval
08/24/2021 FLOLAN
NDA #020444
SUPPL-25 EPOPROSTENOL SODIUM GLAXOSMITHKLINE LLC Labeling Approval
08/24/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076024
SUPPL-5 FLUOXETINE HYDROCHLORIDE FOSUN PHARMA Labeling Approval
08/24/2021 LINZESS
NDA #202811
SUPPL-18 LINACLOTIDE ALLERGAN Labeling Approval
08/24/2021 DICLOFENAC SODIUM
ANDA #204132
SUPPL-5 DICLOFENAC SODIUM LUPIN LTD Labeling Approval
08/24/2021 LURASIDONE HYDROCHLORIDE
ANDA #208047
ORIG-1 LURASIDONE HYDROCHLORIDE DR REDDYS LABS LTD Approval
08/24/2021 MAYZENT
NDA #209884
SUPPL-6 SIPONIMOD FUMARIC ACID NOVARTIS Supplement Approval
08/24/2021 METARAMINOL BITARTRATE
ANDA #211304
ORIG-1 METARAMINOL BITARTRATE SLAYBACK PHARMA LLC Approval
08/24/2021 DAPTOMYCIN
ANDA #215316
ORIG-1 DAPTOMYCIN QILU Approval
08/25/2021 PROSCAR
NDA #020180
SUPPL-49 FINASTERIDE MERCK Labeling Approval
08/25/2021 NEXIUM
NDA #021153
SUPPL-56 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
08/25/2021 NEXIUM
NDA #021957
SUPPL-23 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
08/25/2021 NEXIUM
NDA #022101
SUPPL-20 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
08/25/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076006
SUPPL-8 FLUOXETINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
08/25/2021 VECTIBIX
BLA #125147
SUPPL-210 PANITUMUMAB AMGEN Approval
08/25/2021 EVEROLIMUS
ANDA #210130
SUPPL-3 EVEROLIMUS MYLAN Manufacturing (CMC) Approval
08/25/2021 CYCLOPHOSPHAMIDE
NDA #210735
ORIG-1 CYCLOPHOSPHAMIDE AUROMEDICS PHARMA Type 5 - New Formulation or New Manufacturer Approval
08/25/2021 TIBSOVO
NDA #211192
SUPPL-8 IVOSIDENIB SERVIER Efficacy Approval
08/25/2021 ONSURA
ANDA #213977
ORIG-1 ETHINYL ESTRADIOL; NORELGESTROMIN TEVA PHARMS USA Approval
08/25/2021 ACETAMINOPHEN
ANDA #215486
ORIG-1 ACETAMINOPHEN MARKSANS PHARMA Approval
08/25/2021 SKYTROFA
BLA #761177
ORIG-1 LONAPEGSOMATROPIN-TCGD ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S Approval
08/26/2021 LATISSE
NDA #022369
SUPPL-14 BIMATOPROST ALLERGAN Labeling Approval
08/26/2021 DIAZEPAM
ANDA #072370
SUPPL-8 DIAZEPAM WATSON LABS INC Labeling Approval
08/26/2021 DIAZEPAM
ANDA #072370
SUPPL-9 DIAZEPAM WATSON LABS INC Labeling Approval
08/26/2021 FLUOXETINE
ANDA #075662
SUPPL-1 FLUOXETINE HYDROCHLORIDE WATSON LABS Labeling Approval
08/26/2021 OLANZAPINE
ANDA #078109
SUPPL-5 OLANZAPINE PAR PHARM Labeling Approval
08/26/2021 OLANZAPINE
ANDA #078109
SUPPL-7 OLANZAPINE PAR PHARM Labeling Approval
08/26/2021 OLANZAPINE
ANDA #078109
SUPPL-8 OLANZAPINE PAR PHARM Labeling Approval
08/26/2021 OLOPATADINE HYDROCHLORIDE
ANDA #200810
SUPPL-1 OLOPATADINE HYDROCHLORIDE WOCKHARDT LTD Labeling Approval
08/26/2021 OXYCODONE AND ACETAMINOPHEN
ANDA #201448
ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE NOSTRUM LABS INC Approval
08/26/2021 IRBESARTAN
ANDA #203020
SUPPL-2 IRBESARTAN UNICHEM Labeling Approval
08/26/2021 OLOPATADINE HYDROCHLORIDE
ANDA #208637
SUPPL-1 OLOPATADINE HYDROCHLORIDE WATSON LABS INC Labeling Approval
08/26/2021 EPIDIOLEX
NDA #210365
SUPPL-11 CANNABIDIOL GW RES LTD Manufacturing (CMC) Approval
08/26/2021 VANCOMYCIN
NDA #213895
ORIG-1 VANCOMYCIN XELLIA PHARMS APS Type 5 - New Formulation or New Manufacturer Approval
08/26/2021 TOPIRAMATE
ANDA #215414
ORIG-1 TOPIRAMATE ASCENT PHARMS INC Approval
08/27/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075872
SUPPL-25 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
08/27/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075872
SUPPL-27 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
08/27/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076015
SUPPL-16 FLUOXETINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
08/27/2021 FLUOXETINE HYDROCHLORIDE
ANDA #076015
SUPPL-20 FLUOXETINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
08/27/2021 MYDRIACYL
ANDA #084305
SUPPL-38 TROPICAMIDE SANDOZ INC Labeling Approval
08/27/2021 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #088295
SUPPL-24 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/27/2021 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066
SUPPL-12 BUPRENORPHINE HYDROCHLORIDE MYLAN Labeling Approval
08/27/2021 BRIVIACT
NDA #205836
SUPPL-9 BRIVARACETAM UCB INC Efficacy Approval
08/27/2021 BRIVIACT
NDA #205837
SUPPL-7 BRIVARACETAM UCB INC Efficacy Approval
08/27/2021 BRIVIACT
NDA #205838
SUPPL-6 BRIVARACETAM UCB INC Efficacy Approval
08/27/2021 PENICILLAMINE
ANDA #209921
SUPPL-6 PENICILLAMINE ANI PHARMS Labeling Approval
08/27/2021 PAROXETINE HYDROCHLORIDE
ANDA #212645
ORIG-1 PAROXETINE HYDROCHLORIDE CADILA PHARMS LTD Approval
08/27/2021 LOREEV XR
NDA #214826
ORIG-1 LORAZEPAM ALMATICA Type 3 - New Dosage Form Approval
08/30/2021 SUTENT
NDA #021938
SUPPL-39 SUNITINIB MALATE CPPI CV Efficacy Approval
08/30/2021 METRONIDAZOLE
ANDA #070772
SUPPL-44 METRONIDAZOLE AMICI Labeling Approval
08/30/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075506
SUPPL-24 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
08/30/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075514
SUPPL-15 FLUOXETINE HYDROCHLORIDE WOCKHARDT BIO AG Labeling Approval
08/30/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075920
SUPPL-17 FLUOXETINE HYDROCHLORIDE SPECGX LLC Labeling Approval
08/30/2021 IRBESARTAN
ANDA #077466
SUPPL-10 IRBESARTAN SANDOZ Labeling Approval
08/30/2021 RIVASTIGMINE TARTRATE
ANDA #090879
SUPPL-1 RIVASTIGMINE TARTRATE ORCHID HLTHCARE Labeling Approval
08/30/2021 RIVASTIGMINE TARTRATE
ANDA #090879
SUPPL-2 RIVASTIGMINE TARTRATE ORCHID HLTHCARE Labeling Approval
08/30/2021 RABEPRAZOLE SODIUM
ANDA #205761
SUPPL-6 RABEPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/30/2021 INVEGA HAFYERA
NDA #207946
SUPPL-10 PALIPERIDONE PALMITATE JANSSEN PHARMS Efficacy Approval
08/30/2021 INVEGA TRINZA
NDA #207946
SUPPL-10 PALIPERIDONE PALMITATE JANSSEN PHARMS Efficacy Approval
08/30/2021 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #208336
ORIG-1 LINAGLIPTIN; METFORMIN HYDROCHLORIDE SUNSHINE Approval
08/30/2021 PANTOPRAZOLE SODIUM
ANDA #209524
ORIG-1 PANTOPRAZOLE SODIUM ACIC PHARMS Approval
08/30/2021 OSELTAMIVIR PHOSPHATE
ANDA #212858
ORIG-1 OSELTAMIVIR PHOSPHATE APTAPHARMA INC Approval
08/30/2021 TRIENTINE HYDROCHLORIDE
ANDA #212929
ORIG-1 TRIENTINE HYDROCHLORIDE ACCORD HLTHCARE Approval
08/31/2021 REVLIMID
NDA #021880
SUPPL-64 LENALIDOMIDE CELGENE Labeling Approval
08/31/2021 FLUOXETINE HYDROCHLORIDE
ANDA #075525
SUPPL-4 FLUOXETINE HYDROCHLORIDE AKORN Labeling Approval
08/31/2021 MICROGESTIN 1.5/30
ANDA #075548
SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MAYNE PHARMA Labeling Approval
08/31/2021 MICROGESTIN FE 1.5/30
ANDA #075548
SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MAYNE PHARMA Labeling Approval
08/31/2021 MICROGESTIN 1/20
ANDA #075647
SUPPL-27 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MAYNE PHARMA Labeling Approval
08/31/2021 MICROGESTIN FE 1/20
ANDA #075647
SUPPL-27 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MAYNE PHARMA Labeling Approval
08/31/2021 TERBINAFINE HYDROCHLORIDE
ANDA #076377
SUPPL-5 TERBINAFINE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
08/31/2021 TERBINAFINE HYDROCHLORIDE
ANDA #076377
SUPPL-6 TERBINAFINE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
08/31/2021 RISPERIDONE
ANDA #091384
SUPPL-12 RISPERIDONE AMNEAL PHARMS Labeling Approval
08/31/2021 KEYTRUDA
BLA #125514
SUPPL-117 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/31/2021 KEYTRUDA
BLA #125514
SUPPL-118 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/31/2021 SIMVASTATIN
ANDA #200895
SUPPL-8 SIMVASTATIN HETERO LABS LTD III Labeling Approval
08/31/2021 LINAGLIPTIN
ANDA #208335
ORIG-1 LINAGLIPTIN SUNSHINE Approval
08/31/2021 MUPIROCIN
ANDA #213076
ORIG-1 MUPIROCIN CALCIUM ENCUBE Approval
08/31/2021 BRUKINSA
NDA #213217
SUPPL-4 ZANUBRUTINIB BEIGENE Efficacy Approval

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