Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 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 September 19, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/01/2020 PRADAXA
NDA #022512
SUPPL-39 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
07/01/2020 RIFAMPIN
ANDA #065421
SUPPL-8 RIFAMPIN MYLAN LABS LTD Labeling Approval
07/01/2020 RIFAMPIN
ANDA #065421
SUPPL-9 RIFAMPIN MYLAN LABS LTD Labeling Approval
07/01/2020 RIFAMPIN
ANDA #065421
SUPPL-14 RIFAMPIN MYLAN LABS LTD Labeling Approval
07/01/2020 BUMETANIDE
ANDA #074332
SUPPL-15 BUMETANIDE HOSPIRA Labeling Approval
07/01/2020 SUMATRIPTAN SUCCINATE
ANDA #076847
SUPPL-5 SUMATRIPTAN SUCCINATE DR REDDYS LABS INC Labeling Approval
07/01/2020 SUMATRIPTAN SUCCINATE
ANDA #076847
SUPPL-6 SUMATRIPTAN SUCCINATE DR REDDYS LABS INC Labeling Approval
07/01/2020 NATPARA
BLA #125511
SUPPL-20 PARATHYROID HORMONE NPS PHARMS INC Approval
07/01/2020 RIFAMPIN
ANDA #205039
SUPPL-1 RIFAMPIN HIKMA PHARMS Labeling Approval
07/01/2020 RIFAMPIN
ANDA #205039
SUPPL-2 RIFAMPIN HIKMA PHARMS Labeling Approval
07/01/2020 RIFAMPIN
ANDA #205039
SUPPL-3 RIFAMPIN HIKMA PHARMS Labeling Approval
07/01/2020 RIFAMPIN
ANDA #205039
SUPPL-4 RIFAMPIN HIKMA PHARMS Labeling Approval
07/01/2020 ATORVASTATIN CALCIUM
ANDA #205519
SUPPL-21 ATORVASTATIN CALCIUM SCIEGEN PHARMS INC Labeling Approval
07/01/2020 TADALAFIL
ANDA #211298
ORIG-1 TADALAFIL UMEDICA LABS PVT LTD Tentative Approval
07/01/2020 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #213046
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE TARO PHARM INDS LTD Approval
07/01/2020 DOXEPIN HYDROCHLORIDE
ANDA #213063
ORIG-1 DOXEPIN HYDROCHLORIDE TARO PHARM INDS LTD Approval
07/01/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #213199
ORIG-1 FOSAPREPITANT DIMEGLUMINE SUNGEN PHARMA Tentative Approval
07/01/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #213237
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE ACCORD HLTHCARE Approval
07/01/2020 LEVORPHANOL TARTRATE
ANDA #213479
ORIG-1 LEVORPHANOL TARTRATE NOVITIUM PHARMA Approval
07/01/2020 TRIAMCINOLONE ACETONIDE
ANDA #213559
ORIG-1 TRIAMCINOLONE ACETONIDE QUAGEN Approval
07/01/2020 FUROSEMIDE
ANDA #213902
ORIG-1 FUROSEMIDE GLAND PHARMA LTD Approval
07/02/2020 HEPARIN SODIUM
NDA #017029
SUPPL-156 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
07/02/2020 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029
SUPPL-156 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
07/02/2020 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029
SUPPL-156 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
07/02/2020 HEPARIN SODIUM
NDA #017651
SUPPL-66 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
07/02/2020 OMNIPAQUE 12
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 140
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 180
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 210
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 240
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 300
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 350
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 70
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 OMNIPAQUE 9
NDA #018956
SUPPL-105 IOHEXOL GE HEALTHCARE Labeling Approval
07/02/2020 VISIPAQUE 270
NDA #020351
SUPPL-50 IODIXANOL GE HEALTHCARE Labeling Approval
07/02/2020 VISIPAQUE 320
NDA #020351
SUPPL-50 IODIXANOL GE HEALTHCARE Labeling Approval
07/02/2020 SUMAVEL DOSEPRO
NDA #022239
SUPPL-7 SUMATRIPTAN SUCCINATE ENDO VENTURES LTD Labeling Approval
07/02/2020 METHOCARBAMOL
ANDA #040489
SUPPL-15 METHOCARBAMOL OXFORD PHARMS Labeling Approval
07/02/2020 OLOPATADINE HYDROCHLORIDE
ANDA #078350
SUPPL-7 OLOPATADINE HYDROCHLORIDE APOTEX Labeling Approval
07/02/2020 OFLOXACIN
ANDA #078559
SUPPL-12 OFLOXACIN FDC LTD Labeling Approval
07/02/2020 METHOCARBAMOL
ANDA #203550
SUPPL-1 METHOCARBAMOL DBL PHARMS Labeling Approval
07/02/2020 METHOCARBAMOL
ANDA #203550
SUPPL-2 METHOCARBAMOL DBL PHARMS Labeling Approval
07/02/2020 ZOLPIDEM TARTRATE
ANDA #204229
SUPPL-1 ZOLPIDEM TARTRATE PAR PHARM INC Labeling Approval
07/02/2020 ZOLPIDEM TARTRATE
ANDA #204229
SUPPL-2 ZOLPIDEM TARTRATE PAR PHARM INC Labeling Approval
07/02/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #208008
ORIG-1 FINGOLIMOD HYDROCHLORIDE TEVA PHARMS USA Approval
07/02/2020 TRALEMENT
NDA #209376
ORIG-1 CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE AM REGENT Type 4 - New Combination Approval
07/02/2020 APIXABAN
ANDA #210142
ORIG-1 APIXABAN TEVA PHARMS USA INC Tentative Approval
07/02/2020 DEFERASIROX
ANDA #210555
ORIG-2 DEFERASIROX ALKEM LABS LTD Approval
07/02/2020 ERLOTINIB HYDROCHLORIDE
ANDA #211083
ORIG-1 ERLOTINIB HYDROCHLORIDE ACCORD HLTHCARE Approval
07/02/2020 BENDAMUSTINE HYDROCHLORIDE
NDA #212209
ORIG-1 BENDAMUSTINE HYDROCHLORIDE SLAYBACK PHARMA LLC Type 5 - New Formulation or New Manufacturer Tentative Approval
07/02/2020 BYFAVO
NDA #212295
ORIG-1 REMIMAZOLAM BESYLATE ACACIA Type 1 - New Molecular Entity and Type 4 - New Combination Approval
07/02/2020 RUKOBIA
NDA #212950
ORIG-1 FOSTEMSAVIR TROMETHAMINE VIIV HLTHCARE Type 1 - New Molecular Entity Approval
07/06/2020 NORTREL 7/7/7
ANDA #075478
SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE BARR Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502
SUPPL-18 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE FOUGERA PHARMS Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502
SUPPL-19 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE FOUGERA PHARMS Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673
SUPPL-15 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE TARO Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673
SUPPL-18 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE TARO Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673
SUPPL-21 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE TARO Labeling Approval
07/06/2020 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #076002
SUPPL-21 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE ACTAVIS MID ATLANTIC Labeling Approval
07/06/2020 BENAZEPRIL HYDROCHLORIDE
ANDA #076118
SUPPL-24 BENAZEPRIL HYDROCHLORIDE PRINSTON INC Labeling Approval
07/06/2020 CYCLAFEM 7/7/7
ANDA #076338
SUPPL-10 ETHINYL ESTRADIOL; NORETHINDRONE VINTAGE PHARMS LLC Labeling Approval
07/06/2020 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076486
SUPPL-16 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE NOSTRUM LABS INC Labeling Approval
07/06/2020 ARANELLE
ANDA #076783
SUPPL-11 ETHINYL ESTRADIOL; NORETHINDRONE BARR Labeling Approval
07/06/2020 ARANELLE
ANDA #076783
SUPPL-11 NORETHINDRONE; ETHINYL ESTRADIOL BARR Labeling Approval
07/06/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-24 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/06/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-25 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
07/06/2020 DIVALPROEX SODIUM
ANDA #078979
SUPPL-23 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
07/06/2020 DASETTA 7/7/7
ANDA #090946
SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE NOVAST LABS LTD Labeling Approval
07/06/2020 ALYACEN 1/35
ANDA #091634
SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK GENERICS Labeling Approval
07/06/2020 ALYACEN 1/35
ANDA #091634
SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK GENERICS Labeling Approval
07/06/2020 ALYACEN 7/7/7
ANDA #091636
SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK GENERICS Labeling Approval
07/06/2020 ALYACEN 7/7/7
ANDA #091636
SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK GENERICS Labeling Approval
07/06/2020 ALYACEN 777
ANDA #091636
SUPPL-4 NORETHINDRONE; ETHINYL ESTRADIOL GLENMARK GENERICS Labeling Approval
07/06/2020 ALYACEN 777
ANDA #091636
SUPPL-5 NORETHINDRONE; ETHINYL ESTRADIOL GLENMARK GENERICS Labeling Approval
07/06/2020 CYRAMZA
BLA #125477
SUPPL-37 RAMUCIRUMAB ELI LILLY AND CO Approval
07/06/2020 RIFAMPIN
ANDA #206736
SUPPL-1 RIFAMPIN WATSON PHARMS TEVA Labeling Approval
07/06/2020 RIFAMPIN
ANDA #206736
SUPPL-2 RIFAMPIN WATSON PHARMS TEVA Labeling Approval
07/06/2020 RIFAMPIN
ANDA #206736
SUPPL-3 RIFAMPIN WATSON PHARMS TEVA Labeling Approval
07/06/2020 DALFAMPRIDINE
ANDA #206858
ORIG-1 DALFAMPRIDINE MYLAN Approval
07/06/2020 DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
ANDA #207825
ORIG-1 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE MYLAN PHARMS INC Approval
07/06/2020 KISQALI
NDA #209092
SUPPL-5 RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
07/06/2020 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935
SUPPL-8 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
07/06/2020 ERYTHROMYCIN
ANDA #212015
ORIG-1 ERYTHROMYCIN TORRENT Approval
07/06/2020 VERAPAMIL HYDROCHLORIDE
ANDA #212965
ORIG-1 VERAPAMIL HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
07/06/2020 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #213324
ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE UNICHEM LABS LTD Approval
07/06/2020 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #213532
ORIG-1 LEVETIRACETAM NEXUS PHARMS Approval
07/06/2020 QWO
BLA #761146
ORIG-1 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES ENDO GLOBAL AESTHETICS LTD Approval
07/06/2020 HULIO
BLA #761154
ORIG-1 ADALIMUMAB-FKJP MYLAN PHARMS INC Approval
07/07/2020 CERVIDIL
NDA #020411
SUPPL-31 DINOPROSTONE FERRING PHARMS INC Labeling Approval
07/07/2020 VIBATIV
NDA #022110
SUPPL-16 TELAVANCIN HYDROCHLORIDE CUMBERLAND PHARMS Labeling Approval
07/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075869
SUPPL-17 HYDROCHLOROTHIAZIDE; LISINOPRIL TEVA Labeling Approval
07/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075869
SUPPL-18 HYDROCHLOROTHIAZIDE; LISINOPRIL TEVA Labeling Approval
07/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194
SUPPL-35 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
07/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194
SUPPL-37 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
07/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194
SUPPL-38 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
07/07/2020 BETAMETHASONE DIPROPIONATE
ANDA #076215
SUPPL-10 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
07/07/2020 BETAMETHASONE DIPROPIONATE
ANDA #076215
SUPPL-11 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
07/07/2020 BETAMETHASONE DIPROPIONATE
ANDA #076543
SUPPL-12 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
07/07/2020 BETAMETHASONE DIPROPIONATE
ANDA #078930
SUPPL-7 BETAMETHASONE DIPROPIONATE GLENMARK GENERICS Labeling Approval
07/07/2020 BETAMETHASONE DIPROPIONATE
ANDA #078930
SUPPL-8 BETAMETHASONE DIPROPIONATE GLENMARK GENERICS Labeling Approval
07/07/2020 PRASUGREL
ANDA #205926
ORIG-1 PRASUGREL HYDROCHLORIDE DR REDDYS LABS LTD Approval
07/07/2020 EXONDYS 51
NDA #206488
SUPPL-19 ETEPLIRSEN SAREPTA THERAPS INC Labeling Approval
07/07/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #211421
ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE SUNRISE PHARM INC Approval
07/07/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #211816
ORIG-1 CHLORPROMAZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
07/07/2020 EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212359
ORIG-1 EMPAGLIFLOZIN;LINAGLIPTIN MSN LABS PVT LTD Tentative Approval
07/07/2020 INQOVI
NDA #212576
ORIG-1 CEDAZURIDINE; DECITABINE OTSUKA Type 1 - New Molecular Entity Approval
07/08/2020 ETOMIDATE
ANDA #078289
SUPPL-7 ETOMIDATE MYLAN LABS LTD Labeling Approval
07/08/2020 IMATINIB MESYLATE
ANDA #079179
SUPPL-3 IMATINIB MESYLATE APOTEX Labeling Approval
07/08/2020 IMATINIB MESYLATE
ANDA #079179
SUPPL-4 IMATINIB MESYLATE APOTEX Labeling Approval
07/08/2020 IMATINIB MESYLATE
ANDA #079179
SUPPL-6 IMATINIB MESYLATE APOTEX Labeling Approval
07/08/2020 IMATINIB MESYLATE
ANDA #079179
SUPPL-8 IMATINIB MESYLATE APOTEX Labeling Approval
07/08/2020 IMATINIB MESYLATE
ANDA #079179
SUPPL-10 IMATINIB MESYLATE APOTEX Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #090187
SUPPL-3 LEVETIRACETAM APOTEX INC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #090187
SUPPL-4 LEVETIRACETAM APOTEX INC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #090187
SUPPL-5 LEVETIRACETAM APOTEX INC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #090187
SUPPL-6 LEVETIRACETAM APOTEX INC Labeling Approval
07/08/2020 HEPARIN SODIUM
ANDA #090808
SUPPL-25 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
07/08/2020 BOTOX
BLA #103000
SUPPL-5315 OnabotulinumtoxinA ALLERGAN Approval
07/08/2020 BOTOX COSMETIC
BLA #103000
SUPPL-5315 OnabotulinumtoxinA ALLERGAN Approval
07/08/2020 DYSPORT
BLA #125274
SUPPL-118 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
07/08/2020 LEVETIRACETAM
ANDA #201157
SUPPL-1 LEVETIRACETAM PHARM ASSOC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #201157
SUPPL-4 LEVETIRACETAM PHARM ASSOC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #201157
SUPPL-5 LEVETIRACETAM PHARM ASSOC Labeling Approval
07/08/2020 LEVETIRACETAM
ANDA #201157
SUPPL-6 LEVETIRACETAM PHARM ASSOC Labeling Approval
07/08/2020 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #204649
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE STRIDES PHARMA Approval
07/08/2020 METHOCARBAMOL
ANDA #207522
SUPPL-1 METHOCARBAMOL SOMERSET THERAPS LLC Labeling Approval
07/08/2020 METHOCARBAMOL
ANDA #207522
SUPPL-2 METHOCARBAMOL SOMERSET THERAPS LLC Labeling Approval
07/08/2020 DOXYCYCLINE
ANDA #207757
SUPPL-1 DOXYCYCLINE HYCLATE ZYDUS PHARMS Labeling Approval
07/08/2020 OLUMIANT
NDA #207924
SUPPL-2 BARICITINIB ELI LILLY AND CO Labeling Approval
07/08/2020 DIAZOXIDE
ANDA #210799
ORIG-1 DIAZOXIDE NOVITIUM PHARMA Approval
07/08/2020 UPNEEQ
NDA #212520
ORIG-1 OXYMETAZOLINE HYDROCHLORIDE RVL PHARMS Approval
07/08/2020 GLYCOPYRROLATE
ANDA #213238
ORIG-1 GLYCOPYRROLATE ACCORD HLTHCARE Approval
07/09/2020 NEXAVAR
NDA #021923
SUPPL-24 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
07/09/2020 PREGABALIN
ANDA #091025
ORIG-1 PREGABALIN ACTAVIS ELIZABETH Approval
07/09/2020 SIGNIFOR LAR KIT
NDA #203255
SUPPL-8 PASIREOTIDE PAMOATE RECORDATI RARE Labeling Approval
07/09/2020 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #206532
ORIG-1 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE AUROBINDO PHARMA LTD Approval
07/09/2020 IVERMECTIN
ANDA #210019
SUPPL-1 IVERMECTIN TEVA PHARMS USA Manufacturing (CMC) Approval
07/09/2020 BACLOFEN
ANDA #212067
ORIG-1 BACLOFEN UNICHEM LABS LTD Approval
07/09/2020 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #212678
ORIG-1 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE EDENBRIDGE PHARMS Approval
07/09/2020 PREGABALIN
ANDA #213313
ORIG-1 PREGABALIN APOTEX INC Tentative Approval
07/09/2020 FLUPHENAZINE HYDROCHLORIDE
ANDA #213647
ORIG-1 FLUPHENAZINE HYDROCHLORIDE AMNEAL Approval
07/10/2020 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699
SUPPL-33 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Labeling Approval
07/10/2020 SUTENT
NDA #021938
SUPPL-38 SUNITINIB MALATE CPPI CV Labeling Approval
07/10/2020 BUPROPION HYDROCHLORIDE
ANDA #090693
SUPPL-4 BUPROPION HYDROCHLORIDE LUPIN LTD Labeling Approval
07/10/2020 BUPROPION HYDROCHLORIDE
ANDA #090693
SUPPL-10 BUPROPION HYDROCHLORIDE LUPIN LTD Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-6 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-7 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-8 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-9 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-10 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263
SUPPL-11 LEVOCETIRIZINE DIHYDROCHLORIDE L PERRIGO CO Labeling Approval
07/10/2020 ICLUSIG
NDA #203469
SUPPL-33 PONATINIB HYDROCHLORIDE ARIAD Labeling Approval
07/10/2020 VALSARTAN
ANDA #204821
SUPPL-3 VALSARTAN PRINSTON INC Labeling Approval
07/10/2020 VALSARTAN
ANDA #204821
SUPPL-6 VALSARTAN PRINSTON INC Labeling Approval
07/10/2020 EMFLAZA
NDA #208684
SUPPL-4 DEFLAZACORT PTC THERAP Labeling Approval
07/10/2020 EMFLAZA
NDA #208685
SUPPL-4 DEFLAZACORT PTC THERAP Labeling Approval
07/10/2020 ERLEADA
NDA #210951
SUPPL-2 APALUTAMIDE JANSSEN BIOTECH Labeling Approval
07/10/2020 RINVOQ
NDA #211675
SUPPL-1 UPADACITINIB ABBVIE INC Labeling Approval
07/10/2020 ACYCLOVIR
ANDA #212252
ORIG-1 ACYCLOVIR NOVITIUM PHARMA Approval
07/10/2020 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #213917
ORIG-1 MAGNESIUM SULFATE GLAND PHARMA LTD Approval
07/11/2020 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160
SUPPL-2 LEVETIRACETAM AUROBINDO PHARMA LTD Labeling Approval
07/11/2020 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160
SUPPL-3 LEVETIRACETAM AUROBINDO PHARMA LTD Labeling Approval
07/11/2020 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160
SUPPL-4 LEVETIRACETAM AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 IBUPROFEN
ANDA #075139
SUPPL-10 IBUPROFEN LNK Labeling Approval
07/13/2020 RISPERIDONE
ANDA #078452
SUPPL-6 RISPERIDONE AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 RISPERIDONE
ANDA #078452
SUPPL-7 RISPERIDONE AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 RISPERIDONE
ANDA #078452
SUPPL-8 RISPERIDONE AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 RISPERIDONE
ANDA #078452
SUPPL-9 RISPERIDONE AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 RISPERIDONE
ANDA #078452
SUPPL-11 RISPERIDONE AUROBINDO PHARMA LTD Labeling Approval
07/13/2020 MYALEPT
BLA #125390
SUPPL-21 METRELEPTIN AEGERION Approval
07/13/2020 TOBI PODHALER
NDA #201688
SUPPL-10 TOBRAMYCIN MYLAN SPECIALITY LP Labeling Approval
07/13/2020 LITHIUM CARBONATE
ANDA #202288
SUPPL-6 LITHIUM CARBONATE MYLAN PHARMS INC Labeling Approval
07/13/2020 LITHIUM CARBONATE
ANDA #204445
SUPPL-8 LITHIUM CARBONATE ALEMBIC PHARMS LTD Labeling Approval
07/13/2020 LITHIUM CARBONATE
ANDA #204779
SUPPL-6 LITHIUM CARBONATE UNIQUE PHARM LABS Labeling Approval
07/13/2020 PATADAY ONCE DAILY RELIEF
NDA #206276
SUPPL-5 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Efficacy Approval
07/13/2020 AZACITIDINE
NDA #208216
SUPPL-5 AZACITIDINE ACTAVIS LLC Labeling Approval
07/13/2020 ELETRIPTAN HYDROBROMIDE
ANDA #209680
ORIG-1 ELETRIPTAN HYDROBROMIDE YUNG SHIN PHARM Approval
07/13/2020 ICATIBANT ACETATE
ANDA #212446
ORIG-1 ICATIBANT ACETATE CIPLA Approval
07/13/2020 TREMFYA
BLA #761061
SUPPL-7 GUSELKUMAB JANSSEN BIOTECH Approval
07/14/2020 NUTRILIPID 10%
NDA #019531
SUPPL-10 SOYBEAN OIL B BRAUN Labeling Approval
07/14/2020 NUTRILIPID 20%
NDA #019531
SUPPL-10 SOYBEAN OIL B BRAUN Labeling Approval
07/14/2020 ISENTRESS
NDA #022145
SUPPL-42 RALTEGRAVIR POTASSIUM MERCK SHARP DOHME Efficacy Approval
07/14/2020 ISENTRESS HD
NDA #022145
SUPPL-42 RALTEGRAVIR POTASSIUM MERCK SHARP DOHME Efficacy Approval
07/14/2020 ISENTRESS
NDA #203045
SUPPL-16 RALTEGRAVIR POTASSIUM MERCK SHARP DOHME Efficacy Approval
07/14/2020 GATTEX KIT
NDA #203441
SUPPL-19 TEDUGLUTIDE RECOMBINANT NPS PHARMS INC REMS Approval
07/14/2020 ISENTRESS
NDA #205786
SUPPL-8 RALTEGRAVIR POTASSIUM MERCK SHARP DOHME Efficacy Approval
07/14/2020 EPCLUSA
NDA #208341
SUPPL-15 SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC Efficacy Approval
07/14/2020 METHOCARBAMOL
ANDA #209312
SUPPL-4 METHOCARBAMOL GRANULES INDIA LTD Labeling Approval
07/14/2020 METHOCARBAMOL
ANDA #209312
SUPPL-5 METHOCARBAMOL GRANULES INDIA LTD Labeling Approval
07/14/2020 JULUCA
NDA #210192
SUPPL-7 DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE VIIV HLTHCARE Efficacy Approval
07/14/2020 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #210647
ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE ALKEM LABS LTD Approval
07/14/2020 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #213142
ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE TORRENT Approval
07/14/2020 DEFERASIROX
ANDA #213374
ORIG-1 DEFERASIROX ALKEM LABS LTD Approval
07/14/2020 AMPHETAMINE SULFATE
ANDA #213898
ORIG-1 AMPHETAMINE SULFATE MAYNE PHARMA Approval
07/14/2020 BETAMETHASONE DIPROPIONATE
ANDA #214048
ORIG-1 BETAMETHASONE DIPROPIONATE CADILA Approval
07/15/2020 SEPTRA
NDA #017376
SUPPL-65 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
07/15/2020 SEPTRA DS
NDA #017376
SUPPL-65 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
07/15/2020 ENTOCORT EC
NDA #021324
SUPPL-23 BUDESONIDE PERRIGO PHARMA INTL Labeling Approval
07/15/2020 SYNTHROID
NDA #021402
SUPPL-34 LEVOTHYROXINE SODIUM ABBVIE Labeling Approval
07/15/2020 OFLOXACIN
ANDA #076407
SUPPL-3 OFLOXACIN AKORN Labeling Approval
07/15/2020 OFLOXACIN
ANDA #076830
SUPPL-8 OFLOXACIN ALVOGEN Labeling Approval
07/15/2020 AMIODARONE HYDROCHLORIDE
ANDA #077069
SUPPL-10 AMIODARONE HYDROCHLORIDE MURTY PHARMS Labeling Approval
07/15/2020 AMIODARONE HYDROCHLORIDE
ANDA #077069
SUPPL-11 AMIODARONE HYDROCHLORIDE MURTY PHARMS Labeling Approval
07/15/2020 AMIODARONE HYDROCHLORIDE
ANDA #077069
SUPPL-12 AMIODARONE HYDROCHLORIDE MURTY PHARMS Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #088571
SUPPL-28 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #088571
SUPPL-30 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089635
SUPPL-33 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089635
SUPPL-35 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089644
SUPPL-31 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089644
SUPPL-34 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089645
SUPPL-30 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089645
SUPPL-32 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089646
SUPPL-31 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089646
SUPPL-35 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089651
SUPPL-30 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089651
SUPPL-32 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/15/2020 HEPARIN SODIUM
ANDA #090571
SUPPL-20 HEPARIN SODIUM HOSPIRA INC Labeling Approval
07/15/2020 OLOPATADINE HYDROCHLORIDE
ANDA #204392
SUPPL-2 OLOPATADINE HYDROCHLORIDE MYLAN Labeling Approval
07/15/2020 OLOPATADINE HYDROCHLORIDE
ANDA #204812
SUPPL-4 OLOPATADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/15/2020 COLESEVELAM HYDROCHLORIDE
ANDA #209946
ORIG-1 COLESEVELAM HYDROCHLORIDE ZHEJIANG JINGXIN Approval
07/15/2020 OLOPATADINE HYDROCHLORIDE
ANDA #209995
SUPPL-1 OLOPATADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/15/2020 ZEMDRI
NDA #210303
SUPPL-5 PLAZOMICIN SULFATE CIPLA USA Labeling Approval
07/15/2020 SILDENAFIL CITRATE
ANDA #211092
SUPPL-2 SILDENAFIL CITRATE AMNEAL PHARMS Labeling Approval
07/15/2020 HEPARIN SODIUM
ANDA #212061
ORIG-1 HEPARIN SODIUM NANJING KING-FRIEND Approval
07/16/2020 DIGOXIN
ANDA #040481
SUPPL-15 DIGOXIN SANDOZ INC Labeling Approval
07/16/2020 DIGOXIN
ANDA #040481
SUPPL-16 DIGOXIN SANDOZ INC Labeling Approval
07/16/2020 OXYCODONE AND ASPIRIN
ANDA #040910
ORIG-1 ASPIRIN; OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070583
SUPPL-30 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070583
SUPPL-40 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070584
SUPPL-29 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070584
SUPPL-39 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070585
SUPPL-30 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070585
SUPPL-40 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070586
SUPPL-20 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070586
SUPPL-23 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070590
SUPPL-26 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070590
SUPPL-36 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070597
SUPPL-27 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070597
SUPPL-37 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070609
SUPPL-23 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070609
SUPPL-26 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071165
SUPPL-38 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071167
SUPPL-37 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168
SUPPL-29 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168
SUPPL-31 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168
SUPPL-38 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071170
SUPPL-37 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
07/16/2020 PROPOFOL
ANDA #074848
SUPPL-6 PROPOFOL WEST-WARD PHARMS INT Labeling Approval
07/16/2020 PROPOFOL
ANDA #074848
SUPPL-7 PROPOFOL WEST-WARD PHARMS INT Labeling Approval
07/16/2020 PROPOFOL
ANDA #074848
SUPPL-9 PROPOFOL WEST-WARD PHARMS INT Labeling Approval
07/16/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674
SUPPL-19 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
07/16/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606
SUPPL-22 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
07/16/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606
SUPPL-23 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
07/16/2020 DOXORUBICIN HYDROCHLORIDE
ANDA #091495
SUPPL-5 DOXORUBICIN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
07/16/2020 SUMATRIPTAN SUCCINATE
ANDA #200263
SUPPL-2 SUMATRIPTAN SUCCINATE COREPHARMA Labeling Approval
07/16/2020 TELMISARTAN
ANDA #205901
SUPPL-1 TELMISARTAN HETERO LABS LTD V Labeling Approval
07/16/2020 TELMISARTAN
ANDA #205901
SUPPL-2 TELMISARTAN HETERO LABS LTD V Labeling Approval
07/16/2020 TELMISARTAN
ANDA #205901
SUPPL-3 TELMISARTAN HETERO LABS LTD V Labeling Approval
07/16/2020 CABOMETYX
NDA #208692
SUPPL-8 CABOZANTINIB S-MALATE EXELIXIS INC Labeling Approval
07/16/2020 POTASSIUM CHLORIDE
ANDA #210041
SUPPL-3 POTASSIUM CHLORIDE AMNEAL Labeling Approval
07/16/2020 TRANEXAMIC ACID
NDA #212020
SUPPL-3 TRANEXAMIC ACID EXELA PHARMA Labeling Approval
07/16/2020 MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #213585
ORIG-1 MILRINONE LACTATE GLAND PHARMA LTD Approval
07/17/2020 VECTICAL
NDA #022087
SUPPL-9 CALCITRIOL GALDERMA LABS LP Efficacy Approval
07/17/2020 QUTENZA
NDA #022395
SUPPL-19 CAPSAICIN AVERITAS Efficacy Approval
07/17/2020 VOTRIENT
NDA #022465
SUPPL-30 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
07/17/2020 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #204296
SUPPL-1 DROSPIRENONE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
07/17/2020 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #206953
ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MAYNE PHARMA INC Approval
07/17/2020 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #209069
ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE WES PHARMA INC Approval
07/17/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211081
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE APOLLO Approval
07/17/2020 REYVOW
NDA #211280
SUPPL-1 LASMIDITAN SUCCINATE ELI LILLY AND CO Labeling Approval
07/17/2020 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #211543
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE NESHER PHARMS Approval
07/17/2020 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #212394
ORIG-1 EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE ALEMBIC PHARMS LTD Tentative Approval
07/17/2020 CLOPIDOGREL BISULFATE
ANDA #213351
ORIG-1 CLOPIDOGREL BISULFATE POLYGEN PHARMS Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202238
SUPPL-3 GUANFACINE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202238
SUPPL-4 GUANFACINE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202238
SUPPL-5 GUANFACINE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202578
SUPPL-2 GUANFACINE HYDROCHLORIDE MYLAN Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202578
SUPPL-3 GUANFACINE HYDROCHLORIDE MYLAN Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202578
SUPPL-5 GUANFACINE HYDROCHLORIDE MYLAN Labeling Approval
07/18/2020 GUANFACINE HYDROCHLORIDE
ANDA #202578
SUPPL-6 GUANFACINE HYDROCHLORIDE MYLAN Labeling Approval
07/18/2020 TEMOZOLOMIDE
ANDA #204159
SUPPL-1 TEMOZOLOMIDE APOTEX INC Labeling Approval
07/18/2020 TERIFLUNOMIDE
ANDA #209572
SUPPL-2 TERIFLUNOMIDE ALEMBIC PHARMS LTD Labeling Approval
07/18/2020 TERIFLUNOMIDE
ANDA #209601
SUPPL-1 TERIFLUNOMIDE APOTEX Labeling Approval
07/18/2020 TERIFLUNOMIDE
ANDA #209601
SUPPL-2 TERIFLUNOMIDE APOTEX Labeling Approval
07/18/2020 CARBON DIOXIDE, USP
NDA #215007
ORIG-1 CARBON DIOIDE NEXAIR LLC Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075658
SUPPL-30 FLUOXETINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075658
SUPPL-31 FLUOXETINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075658
SUPPL-32 FLUOXETINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #075658
SUPPL-33 FLUOXETINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/20/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #076444
SUPPL-11 HYDROMORPHONE HYDROCHLORIDE BARR Labeling Approval
07/20/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #076444
SUPPL-12 HYDROMORPHONE HYDROCHLORIDE BARR Labeling Approval
07/20/2020 OFLOXACIN
ANDA #076513
SUPPL-20 OFLOXACIN APOTEX INC Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #076554
SUPPL-8 SUMATRIPTAN SUCCINATE SUN PHARM INDS LTD Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #076572
SUPPL-8 SUMATRIPTAN SUCCINATE SUN PHARM INDS LTD Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #078284
SUPPL-7 SUMATRIPTAN SUCCINATE ORCHID HLTHCARE Labeling Approval
07/20/2020 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #078966
SUPPL-9 OMEPRAZOLE; SODIUM BICARBONATE PAR PHARM Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #090314
SUPPL-6 SUMATRIPTAN SUCCINATE MYLAN ASI Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #090314
SUPPL-9 SUMATRIPTAN SUCCINATE MYLAN ASI Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #090641
SUPPL-6 SUMATRIPTAN SUCCINATE MYLAN ASI Labeling Approval
07/20/2020 SUMATRIPTAN SUCCINATE
ANDA #090641
SUPPL-8 SUMATRIPTAN SUCCINATE MYLAN ASI Labeling Approval
07/20/2020 DOCETAXEL
NDA #201195
SUPPL-15 DOCETAXEL ACCORD HLTHCARE Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #201336
SUPPL-1 FLUOXETINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #201336
SUPPL-2 FLUOXETINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #201336
SUPPL-3 FLUOXETINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #201336
SUPPL-4 FLUOXETINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
07/20/2020 FLUOXETINE HYDROCHLORIDE
ANDA #201336
SUPPL-5 FLUOXETINE HYDROCHLORIDE HERITAGE PHARMS INC Labeling Approval
07/20/2020 PRASUGREL
ANDA #205888
SUPPL-3 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/20/2020 OXACILLIN SODIUM
ANDA #206198
ORIG-1 OXACILLIN SODIUM FRESENIUS KABI USA Approval
07/20/2020 TAVABOROLE
ANDA #211297
ORIG-1 TAVABOROLE ENCUBE ETHICALS Tentative Approval
07/20/2020 WYNZORA
NDA #213422
ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MC2 Type 5 - New Formulation or New Manufacturer Approval
07/20/2020 ROPIVACAINE HYDROCHLORIDE
ANDA #214074
ORIG-1 ROPIVACAINE HYDROCHLORIDE HIKMA Approval
07/21/2020 XYREM
NDA #021196
SUPPL-33 SODIUM OXYBATE JAZZ PHARMS Labeling Approval
07/21/2020 XYREM
NDA #021196
SUPPL-34 SODIUM OXYBATE JAZZ PHARMS REMS Approval
07/21/2020 GABAPENTIN
ANDA #075350
SUPPL-60 GABAPENTIN ACTAVIS ELIZABETH Labeling Approval
07/21/2020 GABAPENTIN
ANDA #075350
SUPPL-66 GABAPENTIN ACTAVIS ELIZABETH Labeling Approval
07/21/2020 PAROXETINE HYDROCHLORIDE
ANDA #075356
SUPPL-37 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/21/2020 SIMVASTATIN
ANDA #078034
SUPPL-13 SIMVASTATIN BIOCON LIMITED Labeling Approval
07/21/2020 SIMVASTATIN
ANDA #078034
SUPPL-14 SIMVASTATIN BIOCON LIMITED Labeling Approval
07/21/2020 SUMATRIPTAN SUCCINATE
ANDA #078067
SUPPL-2 SUMATRIPTAN SUCCINATE SANDOZ INC Labeling Approval
07/21/2020 SUMATRIPTAN SUCCINATE
ANDA #078067
SUPPL-3 SUMATRIPTAN SUCCINATE SANDOZ INC Labeling Approval
07/21/2020 LEVETIRACETAM
ANDA #203059
SUPPL-10 LEVETIRACETAM SUN PHARM Labeling Approval
07/21/2020 LEVETIRACETAM
ANDA #203059
SUPPL-11 LEVETIRACETAM SUN PHARM Labeling Approval
07/21/2020 NEVIRAPINE
ANDA #203080
SUPPL-2 NEVIRAPINE MICRO LABS LTD Labeling Approval
07/21/2020 NEVIRAPINE
ANDA #203080
SUPPL-3 NEVIRAPINE MICRO LABS LTD Labeling Approval
07/21/2020 STIVARGA
NDA #203085
SUPPL-13 REGORAFENIB BAYER HLTHCARE Labeling Approval
07/21/2020 LANSOPRAZOLE
ANDA #203306
SUPPL-2 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
07/21/2020 LANSOPRAZOLE
ANDA #203306
SUPPL-3 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
07/21/2020 LANSOPRAZOLE
ANDA #203306
SUPPL-4 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
07/21/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #207183
SUPPL-2 BUPIVACAINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/21/2020 DOXORUBICIN HYDROCHLORIDE
ANDA #209825
SUPPL-3 DOXORUBICIN HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
07/21/2020 DOXORUBICIN HYDROCHLORIDE
ANDA #209825
SUPPL-5 DOXORUBICIN HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
07/21/2020 CHLORZOXAZONE
ANDA #211849
ORIG-1 CHLORZOXAZONE MAYNE PHARMA Approval
07/21/2020 XYWAV
NDA #212690
ORIG-1 CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE JAZZ Approval
07/21/2020 CEFEPIME HYDROCHLORIDE
ANDA #212721
ORIG-1 CEFEPIME HYDROCHLORIDE ASTRAL Approval
07/21/2020 AMIODARONE HYDROCHLORIDE
ANDA #213446
ORIG-1 AMIODARONE HYDROCHLORIDE UNICHEM LABS LTD Approval
07/22/2020 COPAXONE
NDA #020622
SUPPL-110 GLATIRAMER ACETATE TEVA PHARMS USA Labeling Approval
07/22/2020 DUTASTERIDE
ANDA #203118
SUPPL-2 DUTASTERIDE AMNEAL PHARMS Labeling Approval
07/22/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905
SUPPL-2 PHENYLEPHRINE HYDROCHLORIDE SANDOZ INC Labeling Approval
07/22/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905
SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE SANDOZ INC Labeling Approval
07/22/2020 APREMILAST
ANDA #211658
ORIG-1 APREMILAST SANDOZ INC Tentative Approval
07/22/2020 EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212335
ORIG-1 EMPAGLIFLOZIN;LINAGLIPTIN LUPIN LTD Tentative Approval
07/22/2020 GEFITINIB
ANDA #212827
ORIG-1 GEFITINIB NATCO PHARMA LTD Tentative Approval
07/22/2020 MEXILETINE HYDROCHLORIDE
ANDA #213500
ORIG-1 MEXILETINE HYDROCHLORIDE CROSSMEDIKA SA Approval
07/23/2020 EXJADE
NDA #021882
SUPPL-33 DEFERASIROX NOVARTIS Efficacy Approval
07/23/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070704
SUPPL-23 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/23/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070705
SUPPL-22 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/23/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #072042
SUPPL-16 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/23/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #072043
SUPPL-16 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/23/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #076608
SUPPL-5 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE ANI PHARMS INC Labeling Approval
07/23/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #077144
SUPPL-1 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE ANI PHARMS INC Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #078605
SUPPL-13 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #078723
SUPPL-13 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
07/23/2020 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #200154
SUPPL-9 CISATRACURIUM BESYLATE SANDOZ INC Labeling Approval
07/23/2020 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203345
SUPPL-1 OMEPRAZOLE; SODIUM BICARBONATE ZYDUS PHARMS Labeling Approval
07/23/2020 JADENU
NDA #206910
SUPPL-15 DEFERASIROX NOVARTIS PHARMS CORP Efficacy Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207463
SUPPL-2 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207463
SUPPL-3 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207463
SUPPL-4 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207464
SUPPL-1 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207464
SUPPL-2 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 MONTELUKAST SODIUM
ANDA #207464
SUPPL-3 MONTELUKAST SODIUM CIPLA Labeling Approval
07/23/2020 JADENU SPRINKLE
NDA #207968
SUPPL-9 DEFERASIROX NOVARTIS Efficacy Approval
07/23/2020 BREZTRI AEROSPHERE
NDA #212122
ORIG-1 BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE ASTRAZENECA AB Approval
07/23/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #212697
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE PRINSTON INC Approval
07/23/2020 IMATINIB MESYLATE
ANDA #212773
ORIG-1 IMATINIB MESYLATE EUGIA PHARMA Approval
07/24/2020 LEVETIRACETAM
ANDA #077324
SUPPL-8 LEVETIRACETAM FOSUN PHARMA Manufacturing (CMC) Approval
07/24/2020 RAMIPRIL
ANDA #078745
SUPPL-11 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
07/24/2020 LEVETIRACETAM
ANDA #091485
SUPPL-3 LEVETIRACETAM XGEN PHARMS Labeling Approval
07/24/2020 LEVETIRACETAM
ANDA #091485
SUPPL-4 LEVETIRACETAM XGEN PHARMS Labeling Approval
07/24/2020 DOXEPIN HYDROCHLORIDE
ANDA #202510
ORIG-1 DOXEPIN HYDROCHLORIDE PAR PHARM INC Approval
07/24/2020 ACETAMINOPHEN
ANDA #204052
SUPPL-2 ACETAMINOPHEN SANDOZ INC Labeling Approval
07/24/2020 XEGLYZE
NDA #206966
ORIG-1 ABAMETAPIR DR REDDYS LABS SA Type 1 - New Molecular Entity Approval
07/24/2020 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #207310
SUPPL-10 SODIUM CHLORIDE FRESENIUS KABI USA Labeling Approval
07/24/2020 ANASTROZOLE
ANDA #212434
ORIG-1 ANASTROZOLE EUGIA PHARMA Approval
07/24/2020 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #212441
ORIG-1 HEPARIN SODIUM FRESENIUS KABI USA Approval
07/24/2020 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #212441
ORIG-1 HEPARIN SODIUM FRESENIUS KABI USA Approval
07/24/2020 DOXEPIN HYDROCHLORIDE
ANDA #212997
ORIG-1 DOXEPIN HYDROCHLORIDE LANNETT CO INC Approval
07/24/2020 METYROSINE
ANDA #213734
ORIG-1 METYROSINE AMNEAL Approval
07/26/2020 CLOZAPINE
ANDA #201824
SUPPL-11 CLOZAPINE MYLAN Labeling Approval
07/27/2020 NAFCILLIN SODIUM
ANDA #062527
SUPPL-31 NAFCILLIN SODIUM SANDOZ Labeling Approval
07/27/2020 CYCLOSPORINE
ANDA #065167
SUPPL-15 CYCLOSPORINE PHARM ASSOC Labeling Approval
07/27/2020 DIAZEPAM INTENSOL
ANDA #071415
SUPPL-16 DIAZEPAM HIKMA Manufacturing (CMC) Approval
07/27/2020 VINORELBINE TARTRATE
ANDA #078011
SUPPL-4 VINORELBINE TARTRATE ACTAVIS TOTOWA Labeling Approval
07/27/2020 VINORELBINE TARTRATE
ANDA #078011
SUPPL-6 VINORELBINE TARTRATE ACTAVIS TOTOWA Labeling Approval
07/27/2020 NAFCILLIN SODIUM
ANDA #090005
SUPPL-5 NAFCILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
07/27/2020 NAFCILLIN SODIUM
ANDA #090005
SUPPL-6 NAFCILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
07/27/2020 NAFCILLIN SODIUM
ANDA #090005
SUPPL-7 NAFCILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
07/27/2020 VINORELBINE TARTRATE
ANDA #091106
SUPPL-5 VINORELBINE TARTRATE JIANGSU HANSOH PHARM Labeling Approval
07/27/2020 VINORELBINE TARTRATE
ANDA #091106
SUPPL-7 VINORELBINE TARTRATE JIANGSU HANSOH PHARM Labeling Approval
07/27/2020 DOCETAXEL
NDA #203551
SUPPL-9 DOCETAXEL ACTAVIS LLC Labeling Approval
07/27/2020 OXACILLIN SODIUM
ANDA #206199
ORIG-1 OXACILLIN SODIUM FRESENIUS KABI USA Approval
07/27/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210025
SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE PAR STERILE PRODUCTS Labeling Approval
07/27/2020 PYRAZINAMIDE
ANDA #212541
ORIG-1 PYRAZINAMIDE MACLEODS PHARMS LTD Approval
07/28/2020 ALDACTONE
NDA #012151
SUPPL-77 SPIRONOLACTONE PFIZER Labeling Approval
07/28/2020 BACTRIM
NDA #017377
SUPPL-80 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/28/2020 BACTRIM DS
NDA #017377
SUPPL-80 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/28/2020 BACTRIM
NDA #017560
SUPPL-44 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/28/2020 BACTRIM PEDIATRIC
NDA #017560
SUPPL-44 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/28/2020 ARTHROTEC
NDA #020607
SUPPL-33 DICLOFENAC SODIUM; MISOPROSTOL PFIZER Labeling Approval
07/28/2020 FASLODEX
NDA #021344
SUPPL-42 FULVESTRANT ASTRAZENECA Efficacy Approval
07/28/2020 AMPICILLIN AND SULBACTAM
ANDA #065188
SUPPL-10 AMPICILLIN SODIUM; SULBACTAM SODIUM HANFORD GC Manufacturing (CMC) Approval
07/28/2020 GABAPENTIN
ANDA #075360
SUPPL-19 GABAPENTIN GRANULES INDIA LTD Labeling Approval
07/28/2020 GABAPENTIN
ANDA #075360
SUPPL-22 GABAPENTIN GRANULES INDIA LTD Labeling Approval
07/28/2020 GABAPENTIN
ANDA #075360
SUPPL-23 GABAPENTIN GRANULES INDIA LTD Labeling Approval
07/28/2020 GABAPENTIN
ANDA #075360
SUPPL-25 GABAPENTIN GRANULES INDIA LTD Labeling Approval
07/28/2020 OFLOXACIN
ANDA #076622
SUPPL-11 OFLOXACIN BAUSCH AND LOMB Labeling Approval
07/28/2020 NAPROXEN
ANDA #078250
SUPPL-14 NAPROXEN GLENMARK GENERICS Labeling Approval
07/28/2020 NAPROXEN
ANDA #078250
SUPPL-16 NAPROXEN GLENMARK GENERICS Labeling Approval
07/28/2020 NAPROXEN
ANDA #078250
SUPPL-18 NAPROXEN GLENMARK GENERICS Labeling Approval
07/28/2020 NAPROXEN SODIUM
ANDA #078314
SUPPL-6 NAPROXEN SODIUM GLENMARK PHARMS LTD Labeling Approval
07/28/2020 NAPROXEN SODIUM
ANDA #078314
SUPPL-8 NAPROXEN SODIUM GLENMARK PHARMS LTD Labeling Approval
07/28/2020 NAPROXEN SODIUM
ANDA #078314
SUPPL-12 NAPROXEN SODIUM GLENMARK PHARMS LTD Labeling Approval
07/28/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916
SUPPL-65 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/28/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916
SUPPL-69 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-1 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-2 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-4 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-9 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-10 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 LEVETIRACETAM
ANDA #203052
SUPPL-12 LEVETIRACETAM HETERO LABS LTD III Labeling Approval
07/28/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #203129
SUPPL-2 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/28/2020 DOCETAXEL
ANDA #203877
SUPPL-1 DOCETAXEL TEVA PHARMS USA Labeling Approval
07/28/2020 DOCETAXEL
ANDA #203877
SUPPL-3 DOCETAXEL TEVA PHARMS USA Labeling Approval
07/28/2020 DICLOFENAC SODIUM
ANDA #208098
ORIG-1 DICLOFENAC SODIUM TARO Tentative Approval
07/28/2020 APIXABAN
ANDA #210180
ORIG-1 APIXABAN ACCORD HLTHCARE Approval
07/28/2020 DOXEPIN HYDROCHLORIDE
ANDA #213474
ORIG-1 DOXEPIN HYDROCHLORIDE CONTRACT PHARMACAL Approval
07/29/2020 BACTRIM
NDA #018374
SUPPL-27 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDS INC Labeling Approval
07/29/2020 WELCHOL
NDA #021176
SUPPL-48 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO Labeling Approval
07/29/2020 WELCHOL
NDA #022362
SUPPL-28 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO Labeling Approval
07/29/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084282
SUPPL-48 DEXAMETHASONE SODIUM PHOSPHATE WEST-WARD PHARMS INT Labeling Approval
07/29/2020 HYDROCHLOROTHIAZIDE
ANDA #085182
SUPPL-37 HYDROCHLOROTHIAZIDE HERITAGE PHARMS INC Labeling Approval
07/29/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702
SUPPL-39 DEXAMETHASONE SODIUM PHOSPHATE WEST-WARD PHARMS INT Labeling Approval
07/29/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702
SUPPL-41 DEXAMETHASONE SODIUM PHOSPHATE WEST-WARD PHARMS INT Labeling Approval
07/29/2020 STELARA
BLA #125261
SUPPL-150 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
07/29/2020 VERSACLOZ
NDA #203479
SUPPL-12 CLOZAPINE TASMAN PHARMA Labeling Approval
07/29/2020 HEPARIN SODIUM
ANDA #203851
SUPPL-10 HEPARIN SODIUM MYLAN LABS LTD Labeling Approval
07/29/2020 TOLCAPONE
ANDA #207729
ORIG-1 TOLCAPONE ALVOGEN Approval
07/29/2020 NERLYNX
NDA #208051
SUPPL-7 NERATINIB MALEATE PUMA BIOTECH Efficacy Approval
07/29/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #210579
ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE MISEMER Approval
07/29/2020 CLINDAMYCIN PHOSPHATE
ANDA #211872
ORIG-1 CLINDAMYCIN PHOSPHATE SOLARIS PHARMA CORP Approval
07/29/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #213473
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS Approval
07/30/2020 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916
SUPPL-71 HEPARIN SODIUM HOSPIRA Labeling Approval
07/30/2020 DEFINITY
NDA #021064
SUPPL-23 PERFLUTREN LANTHEUS MEDCL Labeling Approval
07/30/2020 ADVIL CONGESTION RELIEF
NDA #022565
SUPPL-6 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
07/30/2020 CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #074896
SUPPL-30 CAPTOPRIL; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
07/30/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075926
SUPPL-15 HYDROCHLOROTHIAZIDE; LISINOPRIL SANDOZ Labeling Approval
07/30/2020 GADAVIST
NDA #201277
SUPPL-18 GADOBUTROL BAYER HLTHCARE Labeling Approval
07/30/2020 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #210502
ORIG-1 CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE DR REDDYS LABS LTD Tentative Approval
07/30/2020 CARBIDOPA; LEODOPA
ANDA #210911
ORIG-1 CARBIDOPA;LEODOPA ZYDUS PHARMS USA INC Tentative Approval
07/30/2020 LEUCOVORIN CALCIUM
ANDA #211132
ORIG-1 LEUCOVORIN CALCIUM RICONPHARMA LLC Approval
07/30/2020 TEGSEDI
NDA #211172
SUPPL-8 INOTERSEN SODIUM AKCEA THERAPS Labeling Approval
07/30/2020 APREMILAST
ANDA #211887
ORIG-1 APREMILAST MSN PHARMACEUTICALS INC Tentative Approval
07/30/2020 CYCLOPHOSPHAMIDE
NDA #212501
ORIG-1 CYCLOPHOSPHAMIDE INGENUS PHARMS LLC Type 5 - New Formulation or New Manufacturer Approval
07/30/2020 TECENTRIQ
BLA #761034
SUPPL-28 ATEZOLIZUMAB GENENTECH INC Approval
07/31/2020 LARIN FE 1.5/30
ANDA #091453
SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Labeling Approval
07/31/2020 ERIVEDGE
NDA #203388
SUPPL-16 VISMODEGIB GENENTECH Labeling Approval
07/31/2020 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #204960
SUPPL-8 CISATRACURIUM BESYLATE JIANGSU HENGRUI MED Labeling Approval
07/31/2020 IBANDRONATE SODIUM
ANDA #205332
SUPPL-4 IBANDRONATE SODIUM AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
07/31/2020 PREZCOBIX
NDA #205395
SUPPL-16 COBICISTAT; DARUNAVIR JANSSEN PRODS Efficacy Approval
07/31/2020 OLANZAPINE
ANDA #206155
ORIG-1 OLANZAPINE INDOCO Approval
07/31/2020 EVOTAZ
NDA #206353
SUPPL-7 ATAZANAVIR SULFATE; COBICISTAT BRISTOL-MYERS SQUIBB Efficacy Approval
07/31/2020 CISATRACURIUM BESYLATE
ANDA #209334
SUPPL-4 CISATRACURIUM BESYLATE JIANGSU HENGRUI MED Labeling Approval
07/31/2020 MAYZENT
NDA #209884
SUPPL-2 SIPONIMOD FUMARIC ACID NOVARTIS Labeling Approval
07/31/2020 EPIDIOLEX
NDA #210365
SUPPL-5 CANNABIDIOL GW RES LTD Efficacy Approval
07/31/2020 EPIDIOLEX
NDA #210365
SUPPL-6 CANNABIDIOL GW RES LTD Efficacy Approval
07/31/2020 EPIDIOLEX
NDA #210365
SUPPL-7 CANNABIDIOL GW RES LTD Labeling Approval
07/31/2020 TIGECYCLINE
NDA #211158
SUPPL-3 TIGECYCLINE AMNEAL Labeling Approval
07/31/2020 SPRAVATO
NDA #211243
SUPPL-4 ESKETAMINE HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
07/31/2020 MYCOPHENOLATE MOFETIL
ANDA #212087
ORIG-1 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD Approval
07/31/2020 NAPROXEN
ANDA #212705
ORIG-1 NAPROXEN AMNEAL Approval
07/31/2020 Monjuvi (tafasitamab-cxix) for injection
BLA #761163
ORIG-1 TAFASITAMAB-CXIX MORPHOSYS US INC Approval

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