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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 2020

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

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

This report was produced on July 21, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/01/2020 XALATAN
NDA #020597
SUPPL-52 LATANOPROST UPJOHN Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062911
SUPPL-43 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062911
SUPPL-47 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062911
SUPPL-55 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062912
SUPPL-52 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062912
SUPPL-74 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062931
SUPPL-27 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062931
SUPPL-29 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062931
SUPPL-31 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062931
SUPPL-39 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062933
SUPPL-33 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062933
SUPPL-35 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062933
SUPPL-38 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062933
SUPPL-46 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #063076
SUPPL-27 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #063076
SUPPL-30 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #063076
SUPPL-39 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
09/01/2020 FENOFIBRATE
ANDA #090715
SUPPL-13 FENOFIBRATE VALEANT PHARMS NORTH Labeling Approval
09/01/2020 COLESEVELAM HYDROCHLORIDE
ANDA #202178
ORIG-1 COLESEVELAM HYDROCHLORIDE WATSON LABS INC Approval
09/01/2020 BARHEMSYS
NDA #209510
SUPPL-2 AMISULPRIDE ACACIA Manufacturing (CMC) Approval
09/01/2020 OMEPRAZOLE
ANDA #210070
SUPPL-1 OMEPRAZOLE APOTEX Manufacturing (CMC) Approval
09/01/2020 ERLEADA
NDA #210951
SUPPL-3 APALUTAMIDE JANSSEN BIOTECH Labeling Approval
09/01/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211079
SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Labeling Approval
09/01/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211079
SUPPL-6 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Labeling Approval
09/01/2020 APREMILAST
ANDA #211700
ORIG-1 APREMILAST PHARMASCIENCE INC Tentative Approval
09/01/2020 FENTANYL CITRATE
ANDA #212086
ORIG-1 FENTANYL CITRATE FRESENIUS KABI USA Approval
09/01/2020 ITRACONAZOLE
ANDA #212239
ORIG-1 ITRACONAZOLE ANNORA PHARMA Approval
09/01/2020 PIQRAY
NDA #212526
SUPPL-1 ALPELISIB NOVARTIS Labeling Approval
09/01/2020 MIDODRINE HYDROCHLORIDE
ANDA #213055
ORIG-1 MIDODRINE HYDROCHLORIDE ZYDUS LIFESCIENCES Approval
09/01/2020 CISATRACURIUM BESYLATE
ANDA #213527
ORIG-1 CISATRACURIUM BESYLATE ZYDUS PHARMS Approval
09/01/2020 QDOLO
NDA #214044
ORIG-1 TRAMADOL HYDROCHLORIDE ATHENA Type 3 - New Dosage Form Approval
09/01/2020 ONUREG
NDA #214120
ORIG-1 AZACITIDINE BRISTOL Type 3 - New Dosage Form Approval
09/02/2020 CORLOPAM
NDA #019922
SUPPL-19 FENOLDOPAM MESYLATE HOSPIRA Labeling Approval
09/02/2020 RIFAMPIN
ANDA #065390
SUPPL-17 RIFAMPIN CHARTWELL MOLECULAR Labeling Approval
09/02/2020 COLESEVELAM HYDROCHLORIDE
ANDA #200830
ORIG-1 COLESEVELAM HYDROCHLORIDE WATSON LABS INC Approval
09/02/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #200837
SUPPL-5 VANCOMYCIN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
09/02/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #200837
SUPPL-8 VANCOMYCIN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
09/02/2020 NITYR
NDA #209449
SUPPL-5 NITISINONE CYCLE Efficacy Approval
09/02/2020 NUZYRA
NDA #209816
SUPPL-8 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
09/02/2020 NUZYRA
NDA #209817
SUPPL-7 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
09/02/2020 PREDNISONE
ANDA #210785
ORIG-1 PREDNISONE STRIDES PHARMA Approval
09/02/2020 ICATIBANT ACETATE
ANDA #211501
ORIG-1 ICATIBANT ACETATE SLAYBACK PHARMA LLC Approval
09/02/2020 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #213269
ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE TARO Approval
09/03/2020 GLUCAGEN
NDA #020918
SUPPL-53 GLUCAGON HYDROCHLORIDE NOVO NORDISK Labeling Approval
09/03/2020 TRULICITY
BLA #125469
SUPPL-36 DULAGLUTIDE ELI LILLY AND CO Approval
09/03/2020 FAMCICLOVIR
ANDA #202438
SUPPL-1 FAMCICLOVIR HETERO LABS LTD V Labeling Approval
09/03/2020 FAMCICLOVIR
ANDA #202438
SUPPL-3 FAMCICLOVIR HETERO LABS LTD V Labeling Approval
09/03/2020 TRAVOPROST
ANDA #203431
SUPPL-10 TRAVOPROST APOTEX Labeling Approval
09/03/2020 MILRINONE LACTATE IN DEXTROSE 5%
ANDA #209666
ORIG-1 MILRINONE LACTATE EUGIA PHARMA Approval
09/03/2020 ARIPIPRAZOLE
ANDA #210260
ORIG-1 ARIPIPRAZOLE CADILA PHARMS LTD Tentative Approval
09/03/2020 VANCOMYCIN HYDROCHLORIDE
NDA #211962
SUPPL-3 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Labeling Approval
09/03/2020 DETECTNET
NDA #213227
ORIG-1 COPPER CU-64 DOTATATE RADIOMEDIX Type 1 - New Molecular Entity Approval
09/04/2020 VFEND
NDA #021266
SUPPL-48 VORICONAZOLE PF PRISM CV Labeling Approval
09/04/2020 VFEND
NDA #021267
SUPPL-58 VORICONAZOLE PF PRISM CV Labeling Approval
09/04/2020 VFEND
NDA #021630
SUPPL-37 VORICONAZOLE PF PRISM CV Labeling Approval
09/04/2020 LOVAZA
NDA #021654
SUPPL-44 OMEGA-3-ACID ETHYL ESTERS WOODWARD Labeling Approval
09/04/2020 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #077847
SUPPL-5 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE HIKMA Labeling Approval
09/04/2020 MONTELUKAST SODIUM
ANDA #091414
SUPPL-14 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
09/04/2020 MONTELUKAST SODIUM
ANDA #091414
SUPPL-16 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
09/04/2020 MONTELUKAST SODIUM
ANDA #200889
SUPPL-12 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
09/04/2020 MONTELUKAST SODIUM
ANDA #200889
SUPPL-13 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
09/04/2020 DUTASTERIDE
ANDA #200899
SUPPL-2 DUTASTERIDE CHARTWELL Labeling Approval
09/04/2020 DUTASTERIDE
ANDA #202204
SUPPL-1 DUTASTERIDE HIKMA Labeling Approval
09/04/2020 DOCETAXEL
ANDA #203170
SUPPL-8 DOCETAXEL HENGRUI PHARMA Labeling Approval
09/04/2020 DOCETAXEL
ANDA #203170
SUPPL-9 DOCETAXEL HENGRUI PHARMA Labeling Approval
09/04/2020 ALFUZOSIN HYDROCHLORIDE
ANDA #203192
SUPPL-7 ALFUZOSIN HYDROCHLORIDE UNICHEM Labeling Approval
09/04/2020 RIZATRIPTAN BENZOATE
ANDA #203478
SUPPL-1 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Labeling Approval
09/04/2020 RIZATRIPTAN BENZOATE
ANDA #203478
SUPPL-2 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Labeling Approval
09/04/2020 ACETYLCYSTEINE
ANDA #203624
SUPPL-4 ACETYLCYSTEINE RISING Labeling Approval
09/04/2020 OXALIPLATIN
ANDA #203869
SUPPL-6 OXALIPLATIN HENGRUI PHARMA Labeling Approval
09/04/2020 MONTELUKAST SODIUM
ANDA #205107
ORIG-1 MONTELUKAST SODIUM AMNEAL PHARMS Approval
09/04/2020 NILUTAMIDE
ANDA #207631
SUPPL-1 NILUTAMIDE ANI PHARMS Labeling Approval
09/04/2020 DOXEPIN HYDROCHLORIDE
ANDA #210268
ORIG-1 DOXEPIN HYDROCHLORIDE CHARTWELL RX Approval
09/04/2020 GAVRETO
NDA #213721
ORIG-1 PRALSETINIB RIGEL PHARMS Type 1 - New Molecular Entity Approval
09/04/2020 GAVRETO
NDA #213721
SUPPL-1 PRALSETINIB RIGEL PHARMS Type 1 - New Molecular Entity Approval
09/08/2020 DIFLUCAN
NDA #019949
SUPPL-69 FLUCONAZOLE PFIZER Labeling Approval
09/08/2020 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950
SUPPL-68 FLUCONAZOLE PFIZER Labeling Approval
09/08/2020 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950
SUPPL-68 FLUCONAZOLE PFIZER Labeling Approval
09/08/2020 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950
SUPPL-68 FLUCONAZOLE PFIZER Labeling Approval
09/08/2020 DIFLUCAN
NDA #020090
SUPPL-50 FLUCONAZOLE PFIZER Labeling Approval
09/08/2020 DOXYCYCLINE HYCLATE
ANDA #062269
SUPPL-29 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
09/08/2020 DOXYCYCLINE HYCLATE
ANDA #062269
SUPPL-31 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
09/08/2020 DOXYCYCLINE HYCLATE
ANDA #062269
SUPPL-38 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
09/08/2020 DOXYCYCLINE HYCLATE
ANDA #062269
SUPPL-41 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
09/08/2020 DOXYCYCLINE HYCLATE
ANDA #062269
SUPPL-43 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090158
SUPPL-5 GABAPENTIN MYLAN Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090158
SUPPL-6 GABAPENTIN MYLAN Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090158
SUPPL-8 GABAPENTIN MYLAN Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090158
SUPPL-9 GABAPENTIN MYLAN Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090158
SUPPL-10 GABAPENTIN MYLAN Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090705
SUPPL-17 GABAPENTIN INVAGEN PHARMS Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090705
SUPPL-18 GABAPENTIN INVAGEN PHARMS Labeling Approval
09/08/2020 GABAPENTIN
ANDA #090705
SUPPL-27 GABAPENTIN INVAGEN PHARMS Labeling Approval
09/08/2020 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #091431
SUPPL-4 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE APOTEX Labeling Approval
09/08/2020 PIOGLITAZONE HYDROCHLORIDE
ANDA #200044
SUPPL-3 PIOGLITAZONE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
09/08/2020 PIOGLITAZONE HYDROCHLORIDE
ANDA #200044
SUPPL-6 PIOGLITAZONE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
09/08/2020 LINEZOLID
ANDA #200068
SUPPL-2 LINEZOLID HIKMA Labeling Approval
09/08/2020 LINEZOLID
ANDA #200068
SUPPL-3 LINEZOLID HIKMA Labeling Approval
09/08/2020 LINEZOLID
ANDA #200068
SUPPL-6 LINEZOLID HIKMA Labeling Approval
09/08/2020 BIMATOPROST
ANDA #202505
ORIG-1 BIMATOPROST MICRO LABS Approval
09/08/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #213106
ORIG-1 FOSAPREPITANT DIMEGLUMINE QILU PHARM HAINAN Approval
09/08/2020 EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #213345
ORIG-1 EMPAGLIFLOZIN;LINAGLIPTIN ZYDUS PHARMS USA INC Tentative Approval
09/09/2020 DEPO-PROVERA
NDA #020246
SUPPL-43 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
09/09/2020 DEPO-PROVERA
NDA #020246
SUPPL-57 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
09/09/2020 NIASPAN
NDA #020381
SUPPL-54 NIACIN ABBVIE Labeling Approval
09/09/2020 NIASPAN TITRATION STARTER PACK
NDA #020381
SUPPL-54 NIACIN ABBVIE Labeling Approval
09/09/2020 NASONEX
NDA #020762
SUPPL-55 MOMETASONE FUROATE ORGANON LLC Labeling Approval
09/09/2020 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796
SUPPL-23 CEFTRIAXONE SODIUM B BRAUN Labeling Approval
09/09/2020 LOPERAMIDE HYDROCHLORIDE
ANDA #074091
SUPPL-36 LOPERAMIDE HYDROCHLORIDE OHM LABS Labeling Approval
09/09/2020 FAMOTIDINE PRESERVATIVE FREE
ANDA #075622
SUPPL-13 FAMOTIDINE SAGENT Manufacturing (CMC) Approval
09/09/2020 FAMOTIDINE PRESERVATIVE FREE
ANDA #075622
SUPPL-14 FAMOTIDINE SAGENT Labeling Approval
09/09/2020 FAMOTIDINE
ANDA #075651
SUPPL-15 FAMOTIDINE SAGENT Labeling Approval
09/09/2020 RILUZOLE
ANDA #091417
SUPPL-3 RILUZOLE SUN PHARM INDS LTD Labeling Approval
09/09/2020 RILUZOLE
ANDA #091417
SUPPL-11 RILUZOLE SUN PHARM INDS LTD Labeling Approval
09/09/2020 LITHIUM CARBONATE
ANDA #091544
SUPPL-4 LITHIUM CARBONATE GLENMARK PHARMS INC Labeling Approval
09/09/2020 LITHIUM CARBONATE
ANDA #091544
SUPPL-6 LITHIUM CARBONATE GLENMARK PHARMS INC Labeling Approval
09/09/2020 LITHIUM CARBONATE
ANDA #091544
SUPPL-7 LITHIUM CARBONATE GLENMARK PHARMS INC Labeling Approval
09/09/2020 LITHIUM CARBONATE
ANDA #091544
SUPPL-8 LITHIUM CARBONATE GLENMARK PHARMS INC Labeling Approval
09/09/2020 LITHIUM CARBONATE
ANDA #091544
SUPPL-9 LITHIUM CARBONATE GLENMARK PHARMS INC Labeling Approval
09/09/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #204375
SUPPL-2 ZIPRASIDONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/09/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #204375
SUPPL-8 ZIPRASIDONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/09/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #204375
SUPPL-14 ZIPRASIDONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/09/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205272
SUPPL-1 DEXMEDETOMIDINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
09/09/2020 DAPTOMYCIN
ANDA #206005
SUPPL-17 DAPTOMYCIN XELLIA PHARMS APS Labeling Approval
09/09/2020 DAPTOMYCIN
ANDA #206005
SUPPL-19 DAPTOMYCIN XELLIA PHARMS APS Labeling Approval
09/09/2020 SAPROPTERIN DIHYDROCHLORIDE
ANDA #207200
SUPPL-2 SAPROPTERIN DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/09/2020 SAPROPTERIN DIHYDROCHLORIDE
ANDA #207207
SUPPL-1 SAPROPTERIN DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/09/2020 SAPROPTERIN DIHYDROCHLORIDE
ANDA #207207
SUPPL-2 SAPROPTERIN DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/09/2020 TRELEGY ELLIPTA
NDA #209482
SUPPL-10 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Efficacy Approval
09/09/2020 TRELEGY ELLIPTA
NDA #209482
SUPPL-11 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Labeling Approval
09/09/2020 SAPROPTERIN DIHYDROCHLORIDE
ANDA #210027
SUPPL-1 SAPROPTERIN DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/09/2020 SAPROPTERIN DIHYDROCHLORIDE
ANDA #210027
SUPPL-2 SAPROPTERIN DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
09/09/2020 POTASSIUM CHLORIDE 10MEQ
ANDA #211087
ORIG-1 POTASSIUM CHLORIDE FRESENIUS KABI USA Approval
09/09/2020 POTASSIUM CHLORIDE 20MEQ
ANDA #211087
ORIG-1 POTASSIUM CHLORIDE FRESENIUS KABI USA Approval
09/09/2020 POTASSIUM CHLORIDE 40MEQ
ANDA #211087
ORIG-1 POTASSIUM CHLORIDE FRESENIUS KABI USA Approval
09/09/2020 AMMONIA N 13
ANDA #211740
ORIG-1 AMMONIA N-13 UNIV WISCONSIN Approval
09/09/2020 CYANOCOBALAMIN
ANDA #212458
ORIG-1 CYANOCOBALAMIN PADAGIS ISRAEL Approval
09/09/2020 ALOSETRON HYDROCHLORIDE
ANDA #213614
ORIG-1 ALOSETRON HYDROCHLORIDE MANKIND PHARMA Approval
09/09/2020 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #213813
ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE GRANULES Approval
09/10/2020 DIGOXIN
ANDA #040282
SUPPL-23 DIGOXIN RISING Labeling Approval
09/10/2020 VALACYCLOVIR HYDROCHLORIDE
ANDA #078656
SUPPL-3 VALACYCLOVIR HYDROCHLORIDE HIKMA Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-5 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-7 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-9 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-10 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-11 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #091261
SUPPL-14 LEVETIRACETAM APOTEX INC Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-1 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-2 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-3 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-4 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-5 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 LEVETIRACETAM
ANDA #202958
SUPPL-6 LEVETIRACETAM APOTEX Labeling Approval
09/10/2020 DECITABINE
ANDA #203131
SUPPL-8 DECITABINE DR REDDYS Labeling Approval
09/10/2020 DECITABINE
ANDA #203131
SUPPL-9 DECITABINE DR REDDYS Labeling Approval
09/10/2020 DALFAMPRIDINE
ANDA #206836
SUPPL-1 DALFAMPRIDINE ACTAVIS LABS FL INC Labeling Approval
09/10/2020 SORAFENIB TOSYLATE
ANDA #207012
ORIG-1 SORAFENIB TOSYLATE MYLAN Approval
09/10/2020 NINLARO
NDA #208462
SUPPL-7 IXAZOMIB CITRATE TAKEDA PHARMS USA Labeling Approval
09/10/2020 NINLARO
NDA #208462
SUPPL-8 IXAZOMIB CITRATE TAKEDA PHARMS USA Labeling Approval
09/10/2020 DOCETAXEL
ANDA #210072
SUPPL-5 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/10/2020 DOCETAXEL
ANDA #210848
SUPPL-4 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/10/2020 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #212299
ORIG-1 DOXORUBICIN HYDROCHLORIDE ZYDUS LIFESCIENCES Approval
09/10/2020 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
ANDA #212346
ORIG-1 DEXTROSE; POTASSIUM CHLORIDE FRESENIUS KABI USA Approval
09/10/2020 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%
ANDA #212346
ORIG-1 DEXTROSE; POTASSIUM CHLORIDE FRESENIUS KABI USA Approval
09/10/2020 ZAFIRLUKAST
ANDA #212475
ORIG-1 ZAFIRLUKAST ANNORA PHARMA Approval
09/10/2020 LORATADINE
ANDA #214280
ORIG-1 LORATADINE RUBICON Approval
09/11/2020 INFED
NDA #017441
SUPPL-178 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
09/11/2020 PREVACID
NDA #020406
SUPPL-90 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
09/11/2020 VENOFER
NDA #021135
SUPPL-36 FERRIC OXYHYDROXIDE AM REGENT Labeling Approval
09/11/2020 PREVACID
NDA #021428
SUPPL-37 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
09/11/2020 FERAHEME
NDA #022180
SUPPL-24 FERUMOXYTOL COVIS Labeling Approval
09/11/2020 DEXILANT
NDA #022287
SUPPL-31 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065180
SUPPL-9 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065180
SUPPL-10 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065204
SUPPL-26 CEFTRIAXONE SODIUM SANDOZ INC Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065342
SUPPL-14 CEFTRIAXONE SODIUM HIKMA FARMACEUTICA Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065342
SUPPL-15 CEFTRIAXONE SODIUM HIKMA FARMACEUTICA Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065391
SUPPL-10 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
09/11/2020 CEFTRIAXONE
ANDA #065391
SUPPL-11 CEFTRIAXONE SODIUM WOCKHARDT Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #076795
SUPPL-11 LITHIUM CARBONATE APOTEX INC Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #076795
SUPPL-12 LITHIUM CARBONATE APOTEX INC Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #076795
SUPPL-14 LITHIUM CARBONATE APOTEX INC Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #079139
SUPPL-8 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #079139
SUPPL-9 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #079159
SUPPL-2 LITHIUM CARBONATE ALEMBIC LTD Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #079159
SUPPL-5 LITHIUM CARBONATE ALEMBIC LTD Labeling Approval
09/11/2020 LITHIUM CARBONATE
ANDA #079159
SUPPL-8 LITHIUM CARBONATE ALEMBIC LTD Labeling Approval
09/11/2020 INJECTAFER
NDA #203565
SUPPL-13 FERRIC CARBOXYMALTOSE AM REGENT Labeling Approval
09/11/2020 OXYCODONE HYDROCHLORIDE
ANDA #204979
SUPPL-2 OXYCODONE HYDROCHLORIDE ANI PHARMS Labeling Approval
09/11/2020 OXYCODONE HYDROCHLORIDE
ANDA #204979
SUPPL-7 OXYCODONE HYDROCHLORIDE ANI PHARMS Labeling Approval
09/11/2020 OXYCODONE HYDROCHLORIDE
ANDA #204979
SUPPL-8 OXYCODONE HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
09/11/2020 ILOPERIDONE
ANDA #207231
SUPPL-2 ILOPERIDONE INVENTIA Labeling Approval
09/11/2020 MONOFERRIC
NDA #208171
SUPPL-1 FERRIC DERISOMALTOSE PHARMACOSMOS AS Labeling Approval
09/11/2020 ICOSAPENT ETHYL
ANDA #209525
ORIG-1 ICOSAPENT ETHYL TEVA PHARMS USA Approval
09/11/2020 APIXABAN
ANDA #209898
ORIG-1 APIXABAN INDOCO Approval
09/11/2020 TIMOLOL MALEATE
ANDA #212291
ORIG-1 TIMOLOL MALEATE EPIC PHARMA LLC Approval
09/11/2020 CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE
ANDA #212367
ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE PADAGIS ISRAEL Approval
09/11/2020 CETIRIZINE HYDROCHLORIDE
ANDA #213557
ORIG-1 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
09/13/2020 BOTOX
BLA #103000
SUPPL-5317 OnabotulinumtoxinA ALLERGAN Approval
09/13/2020 BOTOX COSMETIC
BLA #103000
SUPPL-5317 OnabotulinumtoxinA ALLERGAN Approval
09/14/2020 LENVIMA
NDA #206947
SUPPL-17 LENVATINIB MESYLATE EISAI INC Labeling Approval
09/14/2020 BUPROPION HYDROCHLORIDE
ANDA #207459
SUPPL-1 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
09/14/2020 BUPROPION HYDROCHLORIDE
ANDA #207459
SUPPL-5 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
09/14/2020 DEXTROSE 5% AND SODIUM CHLORIDE 0.9%
ANDA #211211
ORIG-1 DEXTROSE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/14/2020 CHLORZOXAZONE
ANDA #212053
ORIG-1 CHLORZOXAZONE APTAPHARMA INC Approval
09/14/2020 ACYCLOVIR
ANDA #212173
ORIG-1 ACYCLOVIR YILING Approval
09/15/2020 ADCIRCA
NDA #022332
SUPPL-11 TADALAFIL ELI LILLY CO Labeling Approval
09/15/2020 BRILINTA
NDA #022433
SUPPL-30 TICAGRELOR ASTRAZENECA Labeling Approval
09/15/2020 FAMOTIDINE
ANDA #075709
SUPPL-10 FAMOTIDINE FRESENIUS KABI USA Labeling Approval
09/15/2020 FAMOTIDINE PRESERVATIVE FREE
ANDA #075813
SUPPL-11 FAMOTIDINE FRESENIUS KABI USA Labeling Approval
09/15/2020 BUTORPHANOL TARTRATE
ANDA #078247
SUPPL-5 BUTORPHANOL TARTRATE HIKMA FARMACEUTICA Labeling Approval
09/15/2020 BUTORPHANOL TARTRATE
ANDA #078400
SUPPL-5 BUTORPHANOL TARTRATE HIKMA FARMACEUTICA Labeling Approval
09/15/2020 FAMOTIDINE
ANDA #078641
SUPPL-12 FAMOTIDINE MYLAN LABS LTD Labeling Approval
09/15/2020 FAMOTIDINE PRESERVATIVE FREE
ANDA #078642
SUPPL-8 FAMOTIDINE MYLAN LABS LTD Labeling Approval
09/15/2020 FLUVASTATIN SODIUM
ANDA #090595
SUPPL-3 FLUVASTATIN SODIUM MYLAN PHARMS INC Labeling Approval
09/15/2020 GLIMEPIRIDE
ANDA #091220
SUPPL-15 GLIMEPIRIDE MICRO LABS Labeling Approval
09/15/2020 OLANZAPINE
ANDA #200221
SUPPL-7 OLANZAPINE JUBILANT GENERICS Labeling Approval
09/15/2020 OLANZAPINE
ANDA #200221
SUPPL-8 OLANZAPINE JUBILANT GENERICS Labeling Approval
09/15/2020 OLANZAPINE
ANDA #200221
SUPPL-9 OLANZAPINE JUBILANT GENERICS Labeling Approval
09/15/2020 OLANZAPINE
ANDA #200221
SUPPL-16 OLANZAPINE JUBILANT GENERICS Labeling Approval
09/15/2020 DOXERCALCIFEROL
ANDA #205360
ORIG-1 DOXERCALCIFEROL AVET Approval
09/15/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208266
ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE ENDO OPERATIONS Approval
09/15/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #208988
SUPPL-1 ZIPRASIDONE HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
09/15/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #208988
SUPPL-2 ZIPRASIDONE HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
09/15/2020 DEXTROSE 5% AND SODIUM CHLORIDE 0.225%
ANDA #211221
ORIG-1 DEXTROSE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/15/2020 DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
ANDA #211276
ORIG-1 DEXTROSE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/15/2020 COLCHICINE
ANDA #211519
SUPPL-2 COLCHICINE ZYDUS PHARMS Labeling Approval
09/15/2020 LISINOPRIL
ANDA #212041
ORIG-1 LISINOPRIL SCIEGEN PHARMS INC Approval
09/16/2020 NOXAFIL
NDA #022003
SUPPL-26 POSACONAZOLE SCHERING Labeling Approval
09/16/2020 NOXAFIL
NDA #205053
SUPPL-10 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
09/16/2020 PROPOFOL
ANDA #205576
ORIG-1 PROPOFOL INNOPHARMA Approval
09/16/2020 DECITABINE
NDA #205582
SUPPL-15 DECITABINE SUN PHARM Labeling Approval
09/16/2020 NOXAFIL
NDA #205596
SUPPL-10 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
09/16/2020 ENVARSUS XR
NDA #206406
SUPPL-8 TACROLIMUS VELOXIS PHARMS INC Labeling Approval
09/16/2020 GABAPENTIN
ANDA #206943
SUPPL-1 GABAPENTIN ACI Labeling Approval
09/16/2020 GABAPENTIN
ANDA #206943
SUPPL-4 GABAPENTIN ACI Labeling Approval
09/16/2020 FLECAINIDE ACETATE
ANDA #210683
ORIG-1 FLECAINIDE ACETATE BEXIMCO PHARMS USA Approval
09/17/2020 LISINOPRIL
ANDA #203508
SUPPL-6 LISINOPRIL INVAGEN PHARMS Labeling Approval
09/17/2020 LISINOPRIL
ANDA #203508
SUPPL-15 LISINOPRIL INVAGEN PHARMS Labeling Approval
09/17/2020 BIVALIRUDIN
ANDA #204876
SUPPL-1 BIVALIRUDIN APOTEX Labeling Approval
09/17/2020 BIVALIRUDIN
ANDA #204876
SUPPL-2 BIVALIRUDIN APOTEX Labeling Approval
09/17/2020 BUDESONIDE
ANDA #208851
ORIG-1 BUDESONIDE MYLAN Approval
09/17/2020 DESMOPRESSIN ACETATE
ANDA #210223
ORIG-1 DESMOPRESSIN ACETATE UBI Approval
09/17/2020 YONSA
NDA #210308
SUPPL-1 ABIRATERONE ACETATE SUN PHARM Labeling Approval
09/17/2020 POTASSIUM CHLORIDE
ANDA #210395
ORIG-1 POTASSIUM CHLORIDE ZYDUS PHARMS Approval
09/17/2020 ERYTHROMYCIN LACTOBIONATE
ANDA #211086
ORIG-1 ERYTHROMYCIN LACTOBIONATE EXELA PHARMA Approval
09/17/2020 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
ANDA #212347
ORIG-1 POTASSIUM CHLORIDE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/17/2020 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
ANDA #212347
ORIG-1 POTASSIUM CHLORIDE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/17/2020 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
ANDA #212347
ORIG-1 POTASSIUM CHLORIDE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
09/18/2020 SEROQUEL
NDA #020639
SUPPL-70 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
09/18/2020 INVIRASE
NDA #021785
SUPPL-25 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
09/18/2020 SEROQUEL XR
NDA #022047
SUPPL-41 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
09/18/2020 SEROQUEL XR
NDA #022047
SUPPL-44 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
09/18/2020 CEFOBID
NDA #050551
SUPPL-46 CEFOPERAZONE SODIUM PFIZER Labeling Approval
09/18/2020 LEVETIRACETAM
ANDA #091338
SUPPL-12 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
09/18/2020 LEVETIRACETAM
ANDA #091338
SUPPL-13 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
09/18/2020 LEVETIRACETAM
ANDA #091338
SUPPL-15 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
09/18/2020 ILARIS
BLA #125319
SUPPL-100 CANAKINUMAB NOVARTIS PHARMS Approval
09/18/2020 YERVOY
BLA #125377
SUPPL-112 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
09/18/2020 OPDIVO
BLA #125554
SUPPL-84 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
09/18/2020 OPDIVO
BLA #125554
SUPPL-85 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
09/18/2020 VINORELBINE TARTRATE
ANDA #200148
SUPPL-6 VINORELBINE TARTRATE RISING Labeling Approval
09/18/2020 CINACALCET HYDROCHLORIDE
ANDA #208368
ORIG-1 CINACALCET HYDROCHLORIDE DR REDDYS Approval
09/18/2020 ARMONAIR DIGIHALER
NDA #208798
SUPPL-7 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
09/18/2020 ARMONAIR RESPICLICK
NDA #208798
SUPPL-7 FLUTICASONE PROPIONATE TEVA PHARM Labeling Approval
09/18/2020 MEFENAMIC ACID
ANDA #209209
ORIG-1 MEFENAMIC ACID CHARTWELL RX Approval
09/18/2020 LORATADINE
ANDA #212795
ORIG-1 LORATADINE TENSHI Approval
09/18/2020 POLIVY
BLA #761121
SUPPL-3 POLATUZUMAB VEDOTIN-PIIQ GENENTECH Approval
09/21/2020 DONEPEZIL HYDROCHLORIDE
ANDA #200292
SUPPL-8 DONEPEZIL HYDROCHLORIDE PRINSTON INC Labeling Approval
09/21/2020 RIZATRIPTAN BENZOATE
ANDA #200482
SUPPL-1 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Labeling Approval
09/21/2020 RIZATRIPTAN BENZOATE
ANDA #200482
SUPPL-2 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Labeling Approval
09/21/2020 RIZATRIPTAN BENZOATE
ANDA #201967
SUPPL-3 RIZATRIPTAN BENZOATE GLENMARK PHARMS LTD Labeling Approval
09/21/2020 RIZATRIPTAN BENZOATE
ANDA #201993
SUPPL-3 RIZATRIPTAN BENZOATE MYLAN PHARMS INC Labeling Approval
09/21/2020 RIZATRIPTAN BENZOATE
ANDA #201993
SUPPL-4 RIZATRIPTAN BENZOATE MYLAN PHARMS INC Labeling Approval
09/21/2020 DONEPEZIL HYDROCHLORIDE
ANDA #202114
SUPPL-2 DONEPEZIL HYDROCHLORIDE RISING Labeling Approval
09/21/2020 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #203647
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE STRIDES PHARMA Approval
09/21/2020 AZACITIDINE
ANDA #207234
SUPPL-2 AZACITIDINE NATCO PHARMA LTD Labeling Approval
09/21/2020 AZACITIDINE
ANDA #207234
SUPPL-3 AZACITIDINE NATCO PHARMA LTD Labeling Approval
09/21/2020 PALBOCICLIB
ANDA #213098
ORIG-1 PALBOCICLIB ZYDUS WORLDWIDE DMCC Tentative Approval
09/21/2020 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #213105
ORIG-1 CETIRIZINE HYDROCHLORIDE CATALENT Approval
09/21/2020 LIDOCAINE AND PRILOCAINE
ANDA #213253
ORIG-1 LIDOCAINE; PRILOCAINE RHODES PHARMS Approval
09/21/2020 SUMATRIPTAN
ANDA #213465
ORIG-1 SUMATRIPTAN PADAGIS ISRAEL Approval
09/21/2020 SUMATRIPTAN
ANDA #213650
ORIG-1 SUMATRIPTAN PERRIGO UK FINCO Approval
09/21/2020 PILOCARPINE HYDROCHLORIDE
ANDA #214193
ORIG-1 PILOCARPINE HYDROCHLORIDE AMNEAL Approval
09/22/2020 ERAXIS
NDA #021632
SUPPL-27 ANIDULAFUNGIN VICURON HOLDINGS Efficacy Approval
09/22/2020 ERAXIS
NDA #021632
SUPPL-29 ANIDULAFUNGIN VICURON HOLDINGS Labeling Approval
09/22/2020 AZACITIDINE
ANDA #201537
SUPPL-14 AZACITIDINE DR REDDYS Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202274
SUPPL-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202274
SUPPL-3 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202275
SUPPL-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202275
SUPPL-3 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202275
SUPPL-4 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202464
SUPPL-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #202464
SUPPL-3 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Labeling Approval
09/22/2020 LINZESS
NDA #202811
SUPPL-16 LINACLOTIDE ABBVIE Efficacy Approval
09/22/2020 NAFTIFINE HYDROCHLORIDE
ANDA #210038
ORIG-1 NAFTIFINE HYDROCHLORIDE XIROMED Approval
09/22/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #213158
ORIG-1 ESOMEPRAZOLE MAGNESIUM CISEN Approval
09/23/2020 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931
SUPPL-55 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
09/23/2020 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931
SUPPL-55 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
09/23/2020 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931
SUPPL-55 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
09/23/2020 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
NDA #020849
SUPPL-25 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
09/23/2020 TESTOSTERONE ENANTHATE
ANDA #040647
SUPPL-3 TESTOSTERONE ENANTHATE RISING Labeling Approval
09/23/2020 CEFTRIAXONE
ANDA #065125
SUPPL-28 CEFTRIAXONE SODIUM LUPIN Labeling Approval
09/23/2020 CEFTRIAXONE
ANDA #065125
SUPPL-29 CEFTRIAXONE SODIUM LUPIN Labeling Approval
09/23/2020 ISOFLURANE
ANDA #075225
SUPPL-6 ISOFLURANE HALOCARBON PRODS Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-5 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-7 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-10 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-13 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-15 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/23/2020 TRAMADOL HYDROCHLORIDE
ANDA #203494
SUPPL-16 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
09/23/2020 DOCETAXEL
ANDA #207563
SUPPL-5 DOCETAXEL NOVAST LABS Labeling Approval
09/23/2020 LUMIFY
NDA #208144
SUPPL-11 BRIMONIDINE TARTRATE BAUSCH AND LOMB INC Labeling Approval
09/23/2020 DOCETAXEL
ANDA #208859
SUPPL-4 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/23/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #212133
ORIG-1 HYDROMORPHONE HYDROCHLORIDE ASCENT PHARMS INC Approval
09/24/2020 ARTHROTEC
NDA #020607
SUPPL-36 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
09/24/2020 IMPLANON
NDA #021529
SUPPL-19 ETONOGESTREL ORGANON Labeling Approval
09/24/2020 IMPLANON
NDA #021529
SUPPL-20 ETONOGESTREL ORGANON Labeling Approval
09/24/2020 NEXPLANON
NDA #021529
SUPPL-19 ETONOGESTREL ORGANON Labeling Approval
09/24/2020 NEXPLANON
NDA #021529
SUPPL-20 ETONOGESTREL ORGANON Labeling Approval
09/24/2020 REYATAZ
NDA #021567
SUPPL-44 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
09/24/2020 REVLIMID
NDA #021880
SUPPL-54 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
09/24/2020 BENLYSTA
BLA #125370
SUPPL-71 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
09/24/2020 STIVARGA
NDA #203085
SUPPL-12 REGORAFENIB BAYER HLTHCARE Labeling Approval
09/24/2020 KALYDECO
NDA #203188
SUPPL-33 IVACAFTOR VERTEX PHARMS Efficacy Approval
09/24/2020 REYATAZ
NDA #206352
SUPPL-8 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
09/24/2020 KALYDECO
NDA #207925
SUPPL-11 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
09/24/2020 ALAWAY
ANDA #208158
ORIG-1 KETOTIFEN FUMARATE BAUSCH AND LOMB INC Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210305
ORIG-1 DIMETHYL FUMARATE CIPLA Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210402
ORIG-1 DIMETHYL FUMARATE AMNEAL Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210440
ORIG-1 DIMETHYL FUMARATE ALKEM LABS LTD Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210460
ORIG-1 DIMETHYL FUMARATE MSN Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210499
ORIG-1 DIMETHYL FUMARATE ACCORD HLTHCARE Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210500
ORIG-1 DIMETHYL FUMARATE HETERO LABS LTD III Approval
09/24/2020 DIMETHYL FUMARATE
ANDA #210538
ORIG-1 DIMETHYL FUMARATE ZYDUS PHARMS Approval
09/24/2020 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #213663
ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM GRANULES Approval
09/24/2020 CYANOCOBALAMIN
ANDA #214390
ORIG-1 CYANOCOBALAMIN GLAND PHARMA LTD Approval
09/25/2020 ZOCOR
NDA #019766
SUPPL-101 SIMVASTATIN ORGANON Labeling Approval
09/25/2020 PRAVACHOL
NDA #019898
SUPPL-69 PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB Labeling Approval
09/25/2020 LIPITOR
NDA #020702
SUPPL-78 ATORVASTATIN CALCIUM UPJOHN Labeling Approval
09/25/2020 LESCOL XL
NDA #021192
SUPPL-31 FLUVASTATIN SODIUM SANDOZ Labeling Approval
09/25/2020 XYREM
NDA #021196
SUPPL-32 SODIUM OXYBATE JAZZ PHARMS Efficacy Approval
09/25/2020 ALTOPREV
NDA #021316
SUPPL-36 LOVASTATIN COVIS Labeling Approval
09/25/2020 CRESTOR
NDA #021366
SUPPL-42 ROSUVASTATIN CALCIUM IPR Labeling Approval
09/25/2020 CADUET
NDA #021540
SUPPL-48 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
09/25/2020 VYTORIN
NDA #021687
SUPPL-63 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
09/25/2020 LIVALO
NDA #022363
SUPPL-18 PITAVASTATIN CALCIUM KOWA CO Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075300
SUPPL-10 LOVASTATIN CHARTWELL RX Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075451
SUPPL-25 LOVASTATIN AUROBINDO PHARMA USA Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075551
SUPPL-28 LOVASTATIN TEVA Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075551
SUPPL-29 LOVASTATIN TEVA Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075636
SUPPL-32 LOVASTATIN EPIC PHARMA LLC Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075828
SUPPL-39 LOVASTATIN ACTAVIS ELIZABETH Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075935
SUPPL-8 LOVASTATIN AUROBINDO PHARMA USA Labeling Approval
09/25/2020 FAMOTIDINE
ANDA #075942
SUPPL-12 FAMOTIDINE APOTEX INC Labeling Approval
09/25/2020 LOVASTATIN
ANDA #075991
SUPPL-21 LOVASTATIN CARLSBAD Labeling Approval
09/25/2020 FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
ANDA #076322
SUPPL-11 FAMOTIDINE EPIC PHARMA LLC Labeling Approval
09/25/2020 FAMOTIDINE PRESERVATIVE FREE
ANDA #076324
SUPPL-11 FAMOTIDINE EPIC PHARMA LLC Labeling Approval
09/25/2020 MIRTAZAPINE
ANDA #076541
SUPPL-25 MIRTAZAPINE SUN PHARM INDS INC Labeling Approval
09/25/2020 MIRTAZAPINE
ANDA #076541
SUPPL-26 MIRTAZAPINE SUN PHARM INDS INC Labeling Approval
09/25/2020 LOVASTATIN
ANDA #077748
SUPPL-6 LOVASTATIN COREPHARMA Labeling Approval
09/25/2020 LOVASTATIN
ANDA #078296
SUPPL-26 LOVASTATIN LUPIN Labeling Approval
09/25/2020 FLUVASTATIN SODIUM
ANDA #078407
SUPPL-5 FLUVASTATIN SODIUM TEVA PHARMS Labeling Approval
09/25/2020 FLUVASTATIN SODIUM
ANDA #090595
SUPPL-7 FLUVASTATIN SODIUM MYLAN PHARMS INC Labeling Approval
09/25/2020 CAMPATH
BLA #103948
SUPPL-5177 ALEMTUZUMAB GENZYME Approval
09/25/2020 CAMPATH
BLA #103948
SUPPL-5179 ALEMTUZUMAB GENZYME Approval
09/25/2020 LEMTRADA
BLA #103948
SUPPL-5177 ALEMTUZUMAB GENZYME Approval
09/25/2020 LEMTRADA
BLA #103948
SUPPL-5179 ALEMTUZUMAB GENZYME Approval
09/25/2020 NUCALA
BLA #125526
SUPPL-17 MEPOLIZUMAB GLAXOSMITHKLINE LLC Approval
09/25/2020 OPDIVO
BLA #125554
SUPPL-86 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
09/25/2020 LIPTRUZET
NDA #200153
SUPPL-12 ATORVASTATIN CALCIUM; EZETIMIBE ORGANON Labeling Approval
09/25/2020 XELJANZ
NDA #203214
SUPPL-26 TOFACITINIB CITRATE PF PRISM CV Efficacy Approval
09/25/2020 FLOLIPID
NDA #206679
SUPPL-3 SIMVASTATIN SALERNO PHARMS Labeling Approval
09/25/2020 ZYPITAMAG
NDA #208379
SUPPL-4 PITAVASTATIN MAGNESIUM MEDICURE Labeling Approval
09/25/2020 GALAFOLD
NDA #208623
SUPPL-3 MIGALASTAT HYDROCHLORIDE AMICUS THERAP US Labeling Approval
09/25/2020 EZALLOR SPRINKLE
NDA #208647
SUPPL-4 ROSUVASTATIN CALCIUM SUN PHARM Labeling Approval
09/25/2020 FETROJA
NDA #209445
SUPPL-2 CEFIDEROCOL SULFATE TOSYLATE SHIONOGI INC Efficacy Approval
09/25/2020 NIKITA
NDA #209875
SUPPL-2 PITAVASTATIN SODIUM LUPIN LTD Labeling Approval
09/25/2020 ICATIBANT ACETATE
ANDA #210118
SUPPL-2 ICATIBANT ACETATE TEVA PHARMS USA Labeling Approval
09/25/2020 ICATIBANT ACETATE
ANDA #211021
SUPPL-3 ICATIBANT ACETATE JIANGSU HANSOH PHARM Labeling Approval
09/25/2020 XELJANZ
NDA #213082
ORIG-1 TOFACITINIB CITRATE PFIZER Type 3 - New Dosage Form Approval
09/25/2020 NUCALA
BLA #761122
SUPPL-5 MEPOLIZUMAB GLAXOSMITHKLINE Approval
09/27/2020 COMBIVENT RESPIMAT
NDA #021747
SUPPL-20 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
09/27/2020 KADCYLA
BLA #125427
SUPPL-108 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
09/28/2020 TEKTURNA HCT
NDA #022107
SUPPL-34 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE NODEN PHARMA Labeling Approval
09/28/2020 NOREPINEPHRINE BITARTRATE
ANDA #040455
SUPPL-22 NOREPINEPHRINE BITARTRATE MEITHEAL Labeling Approval
09/28/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075049
SUPPL-35 FLUOXETINE HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
09/28/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075049
SUPPL-36 FLUOXETINE HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
09/28/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075049
SUPPL-39 FLUOXETINE HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
09/28/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075049
SUPPL-40 FLUOXETINE HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
09/28/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075049
SUPPL-42 FLUOXETINE HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
09/28/2020 THIAMINE HYDROCHLORIDE
ANDA #080575
SUPPL-19 THIAMINE HYDROCHLORIDE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-48 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-49 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-51 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-54 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-56 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-57 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 PHENYTOIN SODIUM
ANDA #084307
SUPPL-60 PHENYTOIN SODIUM HIKMA Labeling Approval
09/28/2020 DOCETAXEL
ANDA #210327
SUPPL-1 DOCETAXEL SHILPA Labeling Approval
09/28/2020 DOCETAXEL
ANDA #210327
SUPPL-2 DOCETAXEL SHILPA Labeling Approval
09/28/2020 DOCETAXEL
ANDA #210327
SUPPL-3 DOCETAXEL SHILPA Labeling Approval
09/28/2020 BUPROPION HYDROCHLORIDE
ANDA #211347
SUPPL-1 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Labeling Approval
09/28/2020 ESTRADIOL
ANDA #211396
ORIG-1 ESTRADIOL AMNEAL Approval
09/29/2020 LUMIGAN
NDA #022184
SUPPL-8 BIMATOPROST ABBVIE Labeling Approval
09/29/2020 LATISSE
NDA #022369
SUPPL-12 BIMATOPROST ABBVIE Labeling Approval
09/29/2020 INDOCYANINE GREEN
ANDA #040811
SUPPL-6 INDOCYANINE GREEN RENEW PHARMS Labeling Approval
09/29/2020 ALMOTRIPTAN MALATE
ANDA #078027
SUPPL-2 ALMOTRIPTAN MALATE TEVA PHARMS USA Labeling Approval
09/29/2020 HEPARIN SODIUM
ANDA #091682
SUPPL-13 HEPARIN SODIUM SANDOZ Labeling Approval
09/29/2020 SIMPONI ARIA
BLA #125433
SUPPL-30 GOLIMUMAB JANSSEN BIOTECH Approval
09/29/2020 SIMPONI ARIA
BLA #125433
SUPPL-31 GOLIMUMAB JANSSEN BIOTECH Approval
09/29/2020 UNITUXIN
BLA #125516
SUPPL-25 DINUTUXIMAB UNITED THERAP Approval
09/29/2020 HEPARIN SODIUM
ANDA #201002
SUPPL-9 HEPARIN SODIUM SANDOZ Labeling Approval
09/29/2020 LAPATINIB DITOSYLATE
ANDA #203007
ORIG-1 LAPATINIB DITOSYLATE NATCO PHARMA LTD Approval
09/29/2020 ALBUTEROL SULFATE
ANDA #203760
SUPPL-2 ALBUTEROL SULFATE PADAGIS US Manufacturing (CMC) Approval
09/29/2020 GABAPENTIN
ANDA #204989
SUPPL-4 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #204989
SUPPL-6 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #204989
SUPPL-7 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #204989
SUPPL-9 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #204989
SUPPL-19 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #205101
SUPPL-4 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #205101
SUPPL-6 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #205101
SUPPL-7 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #205101
SUPPL-8 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 GABAPENTIN
ANDA #205101
SUPPL-18 GABAPENTIN SCIEGEN PHARMS INC Labeling Approval
09/29/2020 PROAIR DIGIHALER
NDA #205636
SUPPL-20 ALBUTEROL SULFATE TEVA BRANDED PHARM Labeling Approval
09/29/2020 PROAIR RESPICLICK
NDA #205636
SUPPL-20 ALBUTEROL SULFATE TEVA BRANDED PHARM Labeling Approval
09/29/2020 DOLUTEGRAVIR
ANDA #209565
ORIG-1 DOLUTEGRAVIR HETERO LABS UNIT III Tentative Approval
09/29/2020 HEPARIN SODIUM
ANDA #211004
SUPPL-3 HEPARIN SODIUM NANJING KING-FRIEND Labeling Approval
09/29/2020 HEPARIN SODIUM
ANDA #211005
SUPPL-3 HEPARIN SODIUM NANJING KING-FRIEND Labeling Approval
09/29/2020 ALKINDI SPRINKLE
NDA #213876
ORIG-1 HYDROCORTISONE ETON Type 3 - New Dosage Form Approval
09/29/2020 ATROPINE SULFATE
NDA #214652
ORIG-1 ATROPINE SULFATE ACCORD HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
09/30/2020 PATADAY TWICE DAILY RELIEF
NDA #020688
SUPPL-33 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Labeling Approval
09/30/2020 KEPPRA
NDA #021035
SUPPL-104 LEVETIRACETAM UCB INC Labeling Approval
09/30/2020 KEPPRA
NDA #021505
SUPPL-44 LEVETIRACETAM UCB INC Labeling Approval
09/30/2020 PATADAY ONCE DAILY RELIEF
NDA #021545
SUPPL-23 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Labeling Approval
09/30/2020 KEPPRA
NDA #021872
SUPPL-29 LEVETIRACETAM UCB INC Labeling Approval
09/30/2020 KEPPRA XR
NDA #022285
SUPPL-29 LEVETIRACETAM UCB INC Labeling Approval
09/30/2020 PHOSLYRA
NDA #022581
SUPPL-10 CALCIUM ACETATE FRESENIUS MEDCL Labeling Approval
09/30/2020 TIMOLOL MALEATE
ANDA #074465
SUPPL-6 TIMOLOL MALEATE EPIC PHARMA LLC Labeling Approval
09/30/2020 TIMOLOL MALEATE
ANDA #074466
SUPPL-6 TIMOLOL MALEATE SAPTALIS PHARMS Labeling Approval
09/30/2020 LOSARTAN POTASSIUM
ANDA #077424
SUPPL-14 LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
09/30/2020 LOSARTAN POTASSIUM
ANDA #077459
SUPPL-12 LOSARTAN POTASSIUM HIKMA Labeling Approval
09/30/2020 LOSARTAN POTASSIUM
ANDA #078232
SUPPL-30 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
09/30/2020 MONTELUKAST SODIUM
ANDA #090655
SUPPL-6 MONTELUKAST SODIUM HIKMA Labeling Approval
09/30/2020 MONTELUKAST SODIUM
ANDA #091128
SUPPL-6 MONTELUKAST SODIUM HIKMA Labeling Approval
09/30/2020 AVASTIN
BLA #125085
SUPPL-334 BEVACIZUMAB GENENTECH Approval
09/30/2020 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #203997
ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE BIONPHARMA Approval
09/30/2020 ELETRIPTAN HYDROBROMIDE
ANDA #205152
SUPPL-1 ELETRIPTAN HYDROBROMIDE MYLAN Labeling Approval
09/30/2020 LABETALOL HYDROCHLORIDE
ANDA #212990
ORIG-1 LABETALOL HYDROCHLORIDE EPIC PHARMA LLC Approval
09/30/2020 TECENTRIQ
BLA #761034
SUPPL-29 ATEZOLIZUMAB GENENTECH INC Approval
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