U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
September 2019

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

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

This report was produced on April 26, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/03/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-19 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
09/03/2019 LOSARTAN POTASSIUM
ANDA #091129		 SUPPL-8 LOSARTAN POTASSIUM WATSON LABS Labeling Approval
09/03/2019 LOSARTAN POTASSIUM
ANDA #200290		 SUPPL-3 LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
09/03/2019 LOSARTAN POTASSIUM
ANDA #200290		 SUPPL-4 LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
09/03/2019 VALSARTAN
ANDA #201677		 SUPPL-3 VALSARTAN LUPIN LTD Labeling Approval
09/03/2019 VALSARTAN
ANDA #201677		 SUPPL-4 VALSARTAN LUPIN LTD Labeling Approval
09/03/2019 VALSARTAN
ANDA #205347		 SUPPL-1 VALSARTAN SQUARE PHARMS Labeling Approval
09/03/2019 LATANOPROST
ANDA #206519		 ORIG-1 LATANOPROST EUGIA PHARMA Approval
09/03/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #211009		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ASCENT PHARMS INC Approval
09/04/2019 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916		 SUPPL-63 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-52 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-52 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-52 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-34 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-34 HEPARIN SODIUM HOSPIRA Labeling Approval
09/04/2019 GLYCOPYRROLATE
ANDA #089335		 SUPPL-23 GLYCOPYRROLATE AM REGENT Labeling Approval
09/04/2019 VALSARTAN
ANDA #202696		 SUPPL-13 VALSARTAN MACLEODS PHARMS LTD Labeling Approval
09/04/2019 UPTRAVI
NDA #207947		 SUPPL-7 SELEXIPAG ACTELION Labeling Approval
09/04/2019 LURASIDONE HYDROCHLORIDE
ANDA #208058		 ORIG-1 LURASIDONE HYDROCHLORIDE AVET LIFESCIENCES Approval
09/05/2019 SULFAMETHOXAZOLE AND TRIMETHOPRIM
NDA #018598		 SUPPL-52 SULFAMETHOXAZOLE; TRIMETHOPRIM FOSUN PHARMA Labeling Approval
09/05/2019 SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
NDA #018598		 SUPPL-52 SULFAMETHOXAZOLE; TRIMETHOPRIM FOSUN PHARMA Labeling Approval
09/05/2019 PARAGARD T 380A
NDA #018680		 SUPPL-69 COPPER COOPERSURGICAL Labeling Approval
09/05/2019 PARAGARD T 380A
NDA #018680		 SUPPL-70 COPPER COOPERSURGICAL Labeling Approval
09/05/2019 REMERON
NDA #020415		 SUPPL-35 MIRTAZAPINE ORGANON Labeling Approval
09/05/2019 REMERON SOLTAB
NDA #021208		 SUPPL-25 MIRTAZAPINE ORGANON USA ORGANON Labeling Approval
09/05/2019 METHYLPREDNISOLONE
ANDA #040183		 SUPPL-18 METHYLPREDNISOLONE VINTAGE PHARMS Labeling Approval
09/05/2019 CLINDA-DERM
ANDA #063329		 SUPPL-6 CLINDAMYCIN PHOSPHATE PADAGIS US Labeling Approval
09/05/2019 ANASTROZOLE
ANDA #078921		 SUPPL-8 ANASTROZOLE ZYDUS PHARMS USA INC Labeling Approval
09/05/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 SUPPL-6 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
09/05/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 SUPPL-7 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
09/05/2019 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #079198		 SUPPL-7 OCTREOTIDE ACETATE MYLAN INSTITUTIONAL Labeling Approval
09/05/2019 METFORMIN HYDROCHLORIDE
ANDA #091664		 SUPPL-2 METFORMIN HYDROCHLORIDE LUPIN LTD Labeling Approval
09/05/2019 METFORMIN HYDROCHLORIDE
ANDA #091664		 SUPPL-6 METFORMIN HYDROCHLORIDE LUPIN LTD Labeling Approval
09/05/2019 DONEPEZIL HYDROCHLORIDE
ANDA #202410		 SUPPL-1 DONEPEZIL HYDROCHLORIDE HISUN PHARM HANGZHOU Labeling Approval
09/05/2019 DONEPEZIL HYDROCHLORIDE
ANDA #202656		 SUPPL-2 DONEPEZIL HYDROCHLORIDE RISING Labeling Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #204015		 ORIG-1 FOSAPREPITANT DIMEGLUMINE MYLAN LABS LTD Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #205020		 ORIG-1 FOSAPREPITANT DIMEGLUMINE APOTEX Approval
09/05/2019 BUSULFAN
ANDA #205184		 SUPPL-1 BUSULFAN MYLAN LABS LTD Labeling Approval
09/05/2019 CASPOFUNGIN ACETATE
ANDA #207092		 SUPPL-1 CASPOFUNGIN ACETATE GLAND Labeling Approval
09/05/2019 CASPOFUNGIN ACETATE
ANDA #207092		 SUPPL-3 CASPOFUNGIN ACETATE GLAND Labeling Approval
09/05/2019 DOXYCYCLINE HYCLATE
ANDA #207289		 SUPPL-1 DOXYCYCLINE HYCLATE AMNEAL PHARMS Labeling Approval
09/05/2019 DOXYCYCLINE HYCLATE
ANDA #207289		 SUPPL-3 DOXYCYCLINE HYCLATE AMNEAL PHARMS Labeling Approval
09/05/2019 DOXYCYCLINE HYCLATE
ANDA #207289		 SUPPL-6 DOXYCYCLINE HYCLATE AMNEAL PHARMS Labeling Approval
09/05/2019 DOXYCYCLINE HYCLATE
ANDA #207774		 SUPPL-1 DOXYCYCLINE HYCLATE ZYDUS LIFESCIENCES Labeling Approval
09/05/2019 DOCETAXEL
ANDA #208859		 SUPPL-2 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #209965		 ORIG-1 FOSAPREPITANT DIMEGLUMINE MSN Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
NDA #210064		 ORIG-1 FOSAPREPITANT DIMEGLUMINE TEVA PHARMS USA Type 5 - New Formulation or New Manufacturer Approval
09/05/2019 DOCETAXEL
ANDA #210072		 SUPPL-3 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #210689		 ORIG-1 FOSAPREPITANT DIMEGLUMINE LUPIN LTD Approval
09/05/2019 DOCETAXEL
ANDA #210848		 SUPPL-2 DOCETAXEL MYLAN LABS LTD Labeling Approval
09/05/2019 DOXYCYCLINE HYCLATE
ANDA #211012		 SUPPL-1 DOXYCYCLINE HYCLATE AJANTA PHARMA LTD Labeling Approval
09/05/2019 BUPROPION HYDROCHLORIDE
ANDA #211200		 ORIG-1 BUPROPION HYDROCHLORIDE ZHEJIANG JUTAI PHARM Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #211624		 ORIG-1 FOSAPREPITANT DIMEGLUMINE ARTHUR GRP Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #211860		 ORIG-1 FOSAPREPITANT DIMEGLUMINE BAXTER HLTHCARE CORP Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #212309		 ORIG-1 FOSAPREPITANT DIMEGLUMINE BE PHARMS Approval
09/05/2019 ASPARLAS
BLA #761102		 SUPPL-2 CALASPARGASE PEGOL-MKNL SERVIER PHARMA LLC Approval
09/06/2019 PULMICORT RESPULES
NDA #020929		 SUPPL-52 BUDESONIDE ASTRAZENECA Labeling Approval
09/06/2019 VIVITROL
NDA #021897		 SUPPL-45 NALTREXONE ALKERMES Labeling Approval
09/06/2019 PULMICORT FLEXHALER
NDA #021949		 SUPPL-13 BUDESONIDE ASTRAZENECA Labeling Approval
09/06/2019 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113		 SUPPL-8 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
09/06/2019 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113		 SUPPL-8 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
09/06/2019 KEFLEX
NDA #050405		 SUPPL-110 CEPHALEXIN PRAGMA Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071427		 SUPPL-30 TEMAZEPAM CHARTWELL RX Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071427		 SUPPL-31 TEMAZEPAM CHARTWELL RX Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071428		 SUPPL-30 TEMAZEPAM CHARTWELL RX Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071428		 SUPPL-31 TEMAZEPAM CHARTWELL RX Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #074248		 SUPPL-24 CLOBETASOL PROPIONATE TARO Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #074249		 SUPPL-28 CLOBETASOL PROPIONATE TARO Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #075279		 SUPPL-13 CLOBETASOL PROPIONATE TARO Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #075391		 SUPPL-12 CLOBETASOL PROPIONATE FOUGERA PHARMS Labeling Approval
09/06/2019 MESNA
ANDA #075764		 SUPPL-28 MESNA TEVA PHARMS USA Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #076977		 SUPPL-11 CLOBETASOL PROPIONATE ENCUBE Labeling Approval
09/06/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078020		 SUPPL-13 HYDROCHLOROTHIAZIDE; VALSARTAN MYLAN PHARMS INC Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #090898		 SUPPL-4 CLOBETASOL PROPIONATE PADAGIS US Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #090898		 SUPPL-6 CLOBETASOL PROPIONATE PADAGIS US Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #090974		 SUPPL-5 CLOBETASOL PROPIONATE PADAGIS ISRAEL Labeling Approval
09/06/2019 CIMZIA
BLA #125160		 SUPPL-293 CERTOLIZUMAB PEGOL UCB INC Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #200302		 SUPPL-2 CLOBETASOL PROPIONATE TARO Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #201402		 SUPPL-2 CLOBETASOL PROPIONATE PADAGIS ISRAEL Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #201402		 SUPPL-13 CLOBETASOL PROPIONATE PADAGIS ISRAEL Labeling Approval
09/06/2019 AUBAGIO
NDA #202992		 SUPPL-8 TERIFLUNOMIDE SANOFI AVENTIS US Labeling Approval
09/06/2019 MEROPENEM
ANDA #204139		 SUPPL-1 MEROPENEM ACS DOBFAR SPA Labeling Approval
09/06/2019 OFEV
NDA #205832		 SUPPL-12 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Efficacy Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #206378		 SUPPL-3 CLOBETASOL PROPIONATE ZYDUS PHARMS Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #206805		 SUPPL-1 CLOBETASOL PROPIONATE NOVAST LABS Labeling Approval
09/06/2019 MESNA
ANDA #206992		 SUPPL-1 MESNA GLAND Labeling Approval
09/06/2019 MESNA
ANDA #206992		 SUPPL-3 MESNA GLAND Labeling Approval
09/06/2019 DOCETAXEL
ANDA #207563		 SUPPL-2 DOCETAXEL NOVAST LABS Labeling Approval
09/06/2019 DOCETAXEL
ANDA #207563		 SUPPL-4 DOCETAXEL NOVAST LABS Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #208125		 SUPPL-1 CLOBETASOL PROPIONATE LUPIN LTD Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #208667		 SUPPL-1 CLOBETASOL PROPIONATE PAI HOLDINGS PHARM Labeling Approval
09/06/2019 COLCHICINE
ANDA #209876		 ORIG-1 COLCHICINE DR REDDYS Approval
09/06/2019 FENOFIBRATE
ANDA #210670		 ORIG-1 FENOFIBRATE DR REDDYS Approval
09/06/2019 NICOTINE POLACRILEX
ANDA #210712		 ORIG-1 NICOTINE POLACRILEX P AND L Approval
09/06/2019 ACYCLOVIR
ANDA #210774		 ORIG-1 ACYCLOVIR APOTEX Approval
09/06/2019 ETHACRYNIC ACID
ANDA #211719		 ORIG-1 ETHACRYNIC ACID LUPIN LTD Approval
09/06/2019 ALBUTEROL SULFATE
ANDA #212197		 ORIG-1 ALBUTEROL SULFATE QUAGEN Approval
09/06/2019 CLOBAZAM
ANDA #212714		 ORIG-1 CLOBAZAM ALKEM LABS LTD Approval
09/09/2019 PRAVASTATIN SODIUM
ANDA #077491		 SUPPL-5 PRAVASTATIN SODIUM APNAR PHARMA LP Labeling Approval
09/09/2019 RALOXIFENE HYDROCHLORIDE
ANDA #078193		 SUPPL-5 RALOXIFENE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
09/09/2019 RALOXIFENE HYDROCHLORIDE
ANDA #078193		 SUPPL-8 RALOXIFENE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
09/09/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #078225		 SUPPL-14 TAMSULOSIN HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
09/09/2019 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078267		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AMNEAL PHARMS Labeling Approval
09/09/2019 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-7 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
09/09/2019 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-9 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
09/09/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #090931		 SUPPL-10 TAMSULOSIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
09/09/2019 TRAMADOL HYDROCHLORIDE
ANDA #201384		 SUPPL-10 TRAMADOL HYDROCHLORIDE SUN PHARM Labeling Approval
09/09/2019 AZACITIDINE
ANDA #201537		 SUPPL-8 AZACITIDINE DR REDDYS Labeling Approval
09/09/2019 GLUCAGON
NDA #201849		 SUPPL-5 GLUCAGON HYDROCHLORIDE FRESENIUS KABI USA Efficacy Approval
09/09/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #202433		 SUPPL-12 TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/09/2019 TELMISARTAN AND AMLODIPINE
ANDA #202516		 SUPPL-4 AMLODIPINE BESYLATE; TELMISARTAN MYLAN Labeling Approval
09/09/2019 TELMISARTAN AND AMLODIPINE
ANDA #202516		 SUPPL-6 AMLODIPINE BESYLATE; TELMISARTAN MYLAN Labeling Approval
09/09/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #203863		 SUPPL-2 ACETAMINOPHEN; HYDROCODONE BITARTRATE EPIC PHARMA LLC Labeling Approval
09/09/2019 PROCHLORPERAZINE EDISYLATE
ANDA #204147		 SUPPL-21 PROCHLORPERAZINE EDISYLATE AVET LIFESCIENCES Manufacturing (CMC) Approval
09/09/2019 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #205397		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE PADAGIS ISRAEL Approval
09/09/2019 SIVEXTRO
NDA #205435		 SUPPL-11 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
09/09/2019 SIVEXTRO
NDA #205436		 SUPPL-6 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
09/09/2019 MIBELAS 24 FE
ANDA #206287		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN Labeling Approval
09/09/2019 MIBELAS 24 FE
ANDA #206287		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN Labeling Approval
09/09/2019 MIBELAS 24 FE
ANDA #206287		 SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN Manufacturing (CMC) Approval
09/09/2019 CELECOXIB
ANDA #206827		 SUPPL-6 CELECOXIB AUROBINDO PHARMA Labeling Approval
09/09/2019 IBRANCE
NDA #207103		 SUPPL-11 PALBOCICLIB PFIZER Efficacy Approval
09/09/2019 IBRANCE
NDA #207103		 SUPPL-12 PALBOCICLIB PFIZER Labeling Approval
09/09/2019 VERZENIO
NDA #208716		 SUPPL-3 ABEMACICLIB ELI LILLY AND CO Labeling Approval
09/09/2019 KISQALI
NDA #209092		 SUPPL-4 RIBOCICLIB SUCCINATE NOVARTIS Labeling Approval
09/09/2019 CARFILZOMIB
ANDA #209422		 ORIG-1 CARFILZOMIB DR REDDYS Approval
09/09/2019 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935		 SUPPL-7 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS Labeling Approval
09/09/2019 CLOBETASOL PROPIONATE
ANDA #211450		 ORIG-1 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Approval
09/10/2019 ALTABAX
NDA #022055		 SUPPL-7 RETAPAMULIN ALMIRALL Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-17 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-18 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-14 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-16 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-11 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/10/2019 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-13 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
09/10/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201662		 SUPPL-19 HYDROCHLOROTHIAZIDE; VALSARTAN ALEMBIC Labeling Approval
09/10/2019 ACZONE
NDA #207154		 SUPPL-4 DAPSONE ALMIRALL Efficacy Approval
09/10/2019 APIXABAN
ANDA #209944		 ORIG-1 APIXABAN SUNSHINE LAKE Tentative Approval
09/10/2019 VORTIOXETINE
ANDA #210953		 ORIG-1 VORTIOXETINE AMNEAL PHARMS CO Tentative Approval
09/10/2019 GVOKE HYPOPEN
NDA #212097		 ORIG-1 GLUCAGON XERIS Type 3 - New Dosage Form Approval
09/10/2019 GVOKE KIT
NDA #212097		 ORIG-1 GLUCAGON XERIS Type 3 - New Dosage Form Approval
09/10/2019 GVOKE PFS
NDA #212097		 ORIG-1 GLUCAGON XERIS Type 3 - New Dosage Form Approval
09/10/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #212418		 ORIG-1 ACETAMINOPHEN; CODEINE PHOSPHATE ELITE LABS INC Approval
09/11/2019 PAXIL CR
NDA #020936		 SUPPL-47 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-22 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-24 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-16 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-22 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-25 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-20 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-22 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-18 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-20 MYCOPHENOLATE MOFETIL MYLAN Labeling Approval
09/11/2019 AMANTADINE HYDROCHLORIDE
ANDA #071293		 SUPPL-38 AMANTADINE HYDROCHLORIDE SANDOZ Labeling Approval
09/11/2019 AMANTADINE HYDROCHLORIDE
ANDA #071293		 SUPPL-40 AMANTADINE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
09/11/2019 INDOMETHACIN
ANDA #073314		 SUPPL-22 INDOMETHACIN COSETTE Labeling Approval
09/11/2019 INDOMETHACIN
ANDA #073314		 SUPPL-23 INDOMETHACIN COSETTE Labeling Approval
09/11/2019 OXAPROZIN
ANDA #075855		 SUPPL-8 OXAPROZIN DR REDDYS LABS LTD Labeling Approval
09/11/2019 OXAPROZIN
ANDA #075855		 SUPPL-9 OXAPROZIN DR REDDYS LABS LTD Labeling Approval
09/11/2019 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-16 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
09/11/2019 FAMOTIDINE
ANDA #206531		 SUPPL-1 FAMOTIDINE AUROBINDO PHARMA Labeling Approval
09/11/2019 FAMOTIDINE
ANDA #206531		 SUPPL-7 FAMOTIDINE AUROBINDO PHARMA Labeling Approval
09/11/2019 BACLOFEN
ANDA #210048		 ORIG-1 BACLOFEN MAIA PHARMS INC Approval
09/11/2019 DOLUTEGAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE FUMARATE
NDA #210865		 ORIG-1 DOLUTEGAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE FUMARATE MYLAN LABS LTD Type 4 - New Combination Tentative Approval
09/11/2019 DAPAGLIFLOZIN
ANDA #211482		 ORIG-1 DAPAGLIFLOZIN AJANTA PHARMA LTD Tentative Approval
09/12/2019 SABRIL
NDA #020427		 SUPPL-22 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
09/12/2019 DITROPAN XL
NDA #020897		 SUPPL-37 OXYBUTYNIN CHLORIDE JANSSEN PHARMS Labeling Approval
09/12/2019 SABRIL
NDA #022006		 SUPPL-24 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
09/12/2019 NUCALA
BLA #125526		 SUPPL-12 MEPOLIZUMAB GLAXOSMITHKLINE LLC Approval
09/12/2019 CLOPIDOGREL BISULFATE
ANDA #203751		 SUPPL-2 CLOPIDOGREL BISULFATE AMNEAL PHARMS Labeling Approval
09/12/2019 CLOPIDOGREL BISULFATE
ANDA #203751		 SUPPL-3 CLOPIDOGREL BISULFATE AMNEAL PHARMS Labeling Approval
09/12/2019 CLOPIDOGREL BISULFATE
ANDA #203751		 SUPPL-4 CLOPIDOGREL BISULFATE AMNEAL PHARMS Labeling Approval
09/12/2019 CLOPIDOGREL BISULFATE
ANDA #203751		 SUPPL-5 CLOPIDOGREL BISULFATE AMNEAL PHARMS Labeling Approval
09/12/2019 VIGABATRIN
ANDA #208218		 SUPPL-7 VIGABATRIN PAR PHARM INC REMS Approval
09/12/2019 VIGABATRIN
ANDA #209822		 SUPPL-4 VIGABATRIN TEVA PHARMS USA REMS Approval
09/12/2019 VIGABATRIN
ANDA #209824		 SUPPL-5 VIGABATRIN TEVA PHARMS USA REMS Approval
09/12/2019 VIGABATRIN
ANDA #210155		 SUPPL-4 VIGABATRIN AMNEAL PHARMS REMS Approval
09/12/2019 VIGADRONE
ANDA #210196		 SUPPL-3 VIGABATRIN AUCTA REMS Approval
09/12/2019 VIGABATRIN
ANDA #211481		 SUPPL-2 VIGABATRIN DR REDDYS REMS Approval
09/12/2019 IBSRELA
NDA #211801		 ORIG-1 TENAPANOR HYDROCHLORIDE ARDELYX INC Type 1 - New Molecular Entity Approval
09/12/2019 CHLORZOXAZONE
ANDA #212254		 ORIG-1 CHLORZOXAZONE NOVITIUM PHARMA Approval
09/12/2019 NUCALA
BLA #761122		 SUPPL-2 MEPOLIZUMAB GLAXOSMITHKLINE Approval
09/12/2019 NUCALA
BLA #761122		 SUPPL-3 MEPOLIZUMAB GLAXOSMITHKLINE Approval
09/13/2019 MYDAYIS
NDA #022063		 SUPPL-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Efficacy Approval
09/13/2019 ANASTROZOLE
ANDA #091051		 SUPPL-7 ANASTROZOLE MYLAN Labeling Approval
09/13/2019 VALSARTAN
ANDA #091367		 SUPPL-5 VALSARTAN ALEMBIC Labeling Approval
09/13/2019 VALSARTAN
ANDA #091367		 SUPPL-11 VALSARTAN ALEMBIC Labeling Approval
09/13/2019 BENLYSTA
BLA #125370		 SUPPL-67 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
09/13/2019 TEFLARO
NDA #200327		 SUPPL-22 CEFTAROLINE FOSAMIL ABBVIE Efficacy Approval
09/13/2019 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-8 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
09/13/2019 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-10 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
09/13/2019 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-12 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
09/13/2019 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-15 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
09/13/2019 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-19 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
09/13/2019 TRANEXAMIC ACID
ANDA #202436		 SUPPL-3 TRANEXAMIC ACID ACIC PHARMS Labeling Approval
09/13/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #205564		 SUPPL-5 LEVOCETIRIZINE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/13/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #205564		 SUPPL-10 LEVOCETIRIZINE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/13/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #205564		 SUPPL-13 LEVOCETIRIZINE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/13/2019 COLESEVELAM HYDROCHLORIDE
ANDA #208670		 ORIG-1 COLESEVELAM HYDROCHLORIDE BIONPHARMA Approval
09/13/2019 IVERMECTIN
ANDA #210019		 ORIG-1 IVERMECTIN TEVA PHARMS USA Approval
09/13/2019 ZULRESSO
NDA #211371		 SUPPL-2 BREXANOLONE SAGE THERAP Labeling Approval
09/13/2019 MELPHALAN HYDROCHLORIDE
ANDA #211463		 ORIG-1 MELPHALAN HYDROCHLORIDE ARTHUR GRP Approval
09/13/2019 DOLUTEGRAVIR SODIUM
ANDA #212179		 ORIG-1 DOLUTEGRAVIR SODIUM MICRO LABS LTD Tentative Approval
09/13/2019 DOXEPIN HYDROCHLORIDE
ANDA #212624		 ORIG-1 DOXEPIN HYDROCHLORIDE AJANTA PHARMA LTD Approval
09/13/2019 NADOLOL
ANDA #212856		 ORIG-1 NADOLOL RK PHARMA Approval
09/13/2019 BENLYSTA
BLA #761043		 SUPPL-5 BELIMUMAB GLAXOSMITHKLINE LLC Approval
09/13/2019 CYLTEZO
BLA #761058		 SUPPL-3 ADALIMUMAB-ADBM BOEHRINGER INGELHEIM Approval
09/15/2019 MESNA
ANDA #075811		 SUPPL-14 MESNA FRESENIUS KABI USA Labeling Approval
09/16/2019 CLEOCIN
NDA #050767		 SUPPL-16 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-2 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-3 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-5 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296		 SUPPL-6 PANTOPRAZOLE SODIUM SANDOZ Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-12 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-14 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-15 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-17 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090970		 SUPPL-18 PANTOPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
09/16/2019 EZETIMIBE AND SIMVASTATIN
ANDA #202968		 SUPPL-2 EZETIMIBE; SIMVASTATIN WATSON LABS INC Labeling Approval
09/16/2019 EZETIMIBE AND SIMVASTATIN
ANDA #202968		 SUPPL-3 EZETIMIBE; SIMVASTATIN WATSON LABS INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #205119		 SUPPL-2 PANTOPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #205119		 SUPPL-3 PANTOPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #205119		 SUPPL-4 PANTOPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #205119		 SUPPL-5 PANTOPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #205119		 SUPPL-7 PANTOPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
09/16/2019 TRIENTINE HYDROCHLORIDE
ANDA #209415		 ORIG-1 TRIENTINE HYDROCHLORIDE CHARTWELL RX Approval
09/16/2019 COLCHICINE
ANDA #209470		 ORIG-1 COLCHICINE MYLAN Approval
09/16/2019 ONPATTRO
NDA #210922		 SUPPL-4 PATISIRAN SODIUM ALNYLAM PHARMS INC Labeling Approval
09/16/2019 DECITABINE
ANDA #210984		 ORIG-1 DECITABINE NOVAST LABS Approval
09/16/2019 ALOSETRON HYDROCHLORIDE
ANDA #211621		 ORIG-1 ALOSETRON HYDROCHLORIDE EYWA PHARMA Approval
09/17/2019 THALITONE
NDA #019574		 SUPPL-17 CHLORTHALIDONE CASPER PHARMA LLC Labeling Approval
09/17/2019 TACROLIMUS
ANDA #065461		 SUPPL-32 TACROLIMUS SANDOZ Labeling Approval
09/17/2019 KEYTRUDA
BLA #125514		 SUPPL-65 PEMBROLIZUMAB MERCK SHARP DOHME Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675		 SUPPL-1 PANTOPRAZOLE SODIUM EUGIA PHARMA Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675		 SUPPL-5 PANTOPRAZOLE SODIUM EUGIA PHARMA Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675		 SUPPL-6 PANTOPRAZOLE SODIUM EUGIA PHARMA Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675		 SUPPL-8 PANTOPRAZOLE SODIUM EUGIA PHARMA Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675		 SUPPL-11 PANTOPRAZOLE SODIUM EUGIA PHARMA Labeling Approval
09/17/2019 OLMESARTAN MEDOXOMIL
ANDA #206372		 ORIG-1 OLMESARTAN MEDOXOMIL MICRO LABS Approval
09/17/2019 LENVIMA
NDA #206947		 SUPPL-11 LENVATINIB MESYLATE EISAI INC Efficacy Approval
09/17/2019 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
ANDA #208847		 ORIG-1 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL UMEDICA Approval
09/17/2019 ERLEADA
NDA #210951		 SUPPL-1 APALUTAMIDE JANSSEN BIOTECH Efficacy Approval
09/18/2019 ZANTAC 75
NDA #020520		 SUPPL-38 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/18/2019 ZANTAC 150
NDA #021698		 SUPPL-31 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
09/18/2019 BIAXIN
NDA #050662		 SUPPL-61 CLARITHROMYCIN ABBVIE Labeling Approval
09/18/2019 BIAXIN
NDA #050698		 SUPPL-41 CLARITHROMYCIN ABBVIE Labeling Approval
09/18/2019 BIAXIN XL
NDA #050775		 SUPPL-29 CLARITHROMYCIN ABBVIE Labeling Approval
09/18/2019 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077179		 SUPPL-26 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE TEVA PHARMS Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #090403		 SUPPL-3 INDOMETHACIN ZYDUS LIFESCIENCES Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #090403		 SUPPL-5 INDOMETHACIN ZYDUS LIFESCIENCES Labeling Approval
09/18/2019 EPINEPHRINE (AUTOINJECTOR)
ANDA #090589		 SUPPL-4 EPINEPHRINE TEVA PHARMS USA Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #091549		 SUPPL-3 INDOMETHACIN AMNEAL PHARMS Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #091549		 SUPPL-5 INDOMETHACIN AMNEAL PHARMS Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #091549		 SUPPL-7 INDOMETHACIN AMNEAL PHARMS Labeling Approval
09/18/2019 OPDIVO
BLA #125554		 SUPPL-75 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
09/18/2019 INDOMETHACIN
ANDA #202711		 SUPPL-1 INDOMETHACIN ZYDUS PHARMS Labeling Approval
09/18/2019 CELECOXIB
ANDA #204519		 SUPPL-5 CELECOXIB ALEMBIC Labeling Approval
09/18/2019 CELECOXIB
ANDA #204519		 SUPPL-7 CELECOXIB ALEMBIC Labeling Approval
09/18/2019 OZOBAX
NDA #208193		 ORIG-1 BACLOFEN METACEL PHARMS LLC Type 3 - New Dosage Form Approval
09/18/2019 OZOBAX DS
NDA #208193		 ORIG-1 BACLOFEN METACEL PHARMS LLC Type 3 - New Dosage Form Approval
09/18/2019 DAPTOMYCIN
NDA #209949		 SUPPL-3 DAPTOMYCIN XELLIA PHARMS APS Labeling Approval
09/19/2019 SOMAVERT
BLA #021106		 SUPPL-64 PEGVISOMANT PHARMACIA Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-12 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-13 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-14 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-15 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-16 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 ZOLPIDEM TARTRATE
ANDA #078413		 SUPPL-19 ZOLPIDEM TARTRATE AUROBINDO PHARMA Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750		 SUPPL-9 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750		 SUPPL-10 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750		 SUPPL-11 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750		 SUPPL-14 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200913		 SUPPL-5 CHOLINE FENOFIBRATE MYLAN PHARMS INC Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200913		 SUPPL-6 CHOLINE FENOFIBRATE MYLAN PHARMS INC Labeling Approval
09/19/2019 HEPARIN SODIUM
NDA #201370		 SUPPL-13 HEPARIN SODIUM PFIZER Labeling Approval
09/19/2019 HEPARIN SODIUM
NDA #201370		 SUPPL-14 HEPARIN SODIUM PFIZER Labeling Approval
09/19/2019 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-13 HEPARIN SODIUM PFIZER Labeling Approval
09/19/2019 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-14 HEPARIN SODIUM PFIZER Labeling Approval
09/19/2019 SOVALDI
NDA #204671		 SUPPL-16 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
09/19/2019 HARVONI
NDA #205834		 SUPPL-31 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
09/19/2019 FENOFIBRATE (MICRONIZED)
ANDA #207564		 SUPPL-1 FENOFIBRATE NOVAST LABS Labeling Approval
09/19/2019 EPCLUSA
NDA #208341		 SUPPL-13 SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #208705		 SUPPL-7 CHOLINE FENOFIBRATE ALEMBIC Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #208705		 SUPPL-9 CHOLINE FENOFIBRATE ALEMBIC Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #208705		 SUPPL-11 CHOLINE FENOFIBRATE ALEMBIC Labeling Approval
09/19/2019 FENOFIBRATE
ANDA #208709		 SUPPL-2 FENOFIBRATE CIPLA Labeling Approval
09/19/2019 FENOFIBRATE
ANDA #208709		 SUPPL-3 FENOFIBRATE CIPLA Labeling Approval
09/19/2019 FENOFIBRATE
ANDA #208709		 SUPPL-5 FENOFIBRATE CIPLA Labeling Approval
09/19/2019 ATOVAQUONE
ANDA #209105		 SUPPL-3 ATOVAQUONE LUPIN LTD Labeling Approval
09/19/2019 ATOVAQUONE
ANDA #209105		 SUPPL-5 ATOVAQUONE LUPIN LTD Labeling Approval
09/19/2019 PIFELTRO
NDA #210806		 SUPPL-2 DORAVIRINE MSD MERCK CO Efficacy Approval
09/19/2019 DELSTRIGO
NDA #210807		 SUPPL-2 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MSD MERCK CO Efficacy Approval
09/19/2019 POTASSIUM PHOSPHATES
NDA #212121		 ORIG-1 POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC CMP DEV LLC Type 5 - New Formulation or New Manufacturer Approval
09/19/2019 HARVONI
NDA #212477		 SUPPL-1 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
09/19/2019 SOVALDI
NDA #212480		 SUPPL-1 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
09/20/2019 INVANZ
NDA #021337		 SUPPL-48 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
09/20/2019 JANTOVEN
ANDA #040416		 SUPPL-31 WARFARIN SODIUM UPSHER SMITH LABS Labeling Approval
09/20/2019 JANTOVEN
ANDA #040416		 SUPPL-33 WARFARIN SODIUM UPSHER SMITH LABS Labeling Approval
09/20/2019 TEMAZEPAM
ANDA #071456		 SUPPL-12 TEMAZEPAM NOVEL LABS INC Labeling Approval
09/20/2019 CLOPIDOGREL BISULFATE
ANDA #090540		 SUPPL-19 CLOPIDOGREL BISULFATE AUROBINDO PHARMA LTD Labeling Approval
09/20/2019 PREGABALIN
ANDA #091228		 ORIG-1 PREGABALIN MYLAN Approval
09/20/2019 SOLIFENACIN SUCCINATE
ANDA #091464		 SUPPL-1 SOLIFENACIN SUCCINATE TEVA PHARMS USA Labeling Approval
09/20/2019 YERVOY
BLA #125377		 SUPPL-104 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
09/20/2019 DONEPEZIL HYDROCHLORIDE
ANDA #202415		 SUPPL-4 DONEPEZIL HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
09/20/2019 ZOLMITRIPTAN
ANDA #202855		 ORIG-1 ZOLMITRIPTAN RISING Approval
09/20/2019 CLOPIDOGREL BISULFATE
ANDA #202925		 SUPPL-11 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
09/20/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-20 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
09/20/2019 ATOVAQUONE
ANDA #202960		 SUPPL-7 ATOVAQUONE AMNEAL PHARMS Labeling Approval
09/20/2019 ATOVAQUONE
ANDA #202960		 SUPPL-9 ATOVAQUONE AMNEAL PHARMS Labeling Approval
09/20/2019 DONEPEZIL HYDROCHLORIDE
ANDA #203162		 SUPPL-1 DONEPEZIL HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
09/20/2019 DONEPEZIL HYDROCHLORIDE
ANDA #203713		 SUPPL-3 DONEPEZIL HYDROCHLORIDE DEXCEL Labeling Approval
09/20/2019 VALSARTAN
ANDA #204011		 SUPPL-1 VALSARTAN AMNEAL PHARMS Labeling Approval
09/20/2019 VALSARTAN
ANDA #204011		 SUPPL-2 VALSARTAN AMNEAL PHARMS Labeling Approval
09/20/2019 ATOVAQUONE
ANDA #209750		 SUPPL-3 ATOVAQUONE APOTEX Labeling Approval
09/20/2019 ATOVAQUONE
ANDA #209750		 SUPPL-4 ATOVAQUONE APOTEX Labeling Approval
09/20/2019 CEQUA
NDA #210913		 SUPPL-2 CYCLOSPORINE SUN PHARM Labeling Approval
09/20/2019 RYBELSUS
NDA #213051		 ORIG-1 SEMAGLUTIDE NOVO Type 3 - New Dosage Form Approval
09/23/2019 DELSYM
NDA #018658		 SUPPL-31 DEXTROMETHORPHAN POLISTIREX RB HLTH Manufacturing (CMC) Approval
09/23/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #040163		 SUPPL-3 MEPERIDINE HYDROCHLORIDE SPECGX LLC Labeling Approval
09/23/2019 VINCRISTINE SULFATE PFS
ANDA #071484		 SUPPL-44 VINCRISTINE SULFATE HOSPIRA Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #076520		 SUPPL-12 FENOFIBRATE MYLAN Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #076520		 SUPPL-15 FENOFIBRATE MYLAN Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #076520		 SUPPL-16 FENOFIBRATE MYLAN Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #076520		 SUPPL-17 FENOFIBRATE MYLAN Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #076520		 SUPPL-18 FENOFIBRATE MYLAN Labeling Approval
09/23/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #081002		 SUPPL-9 MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
09/23/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #090856		 SUPPL-10 FENOFIBRATE LUPIN LTD Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #090856		 SUPPL-12 FENOFIBRATE LUPIN LTD Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #090856		 SUPPL-13 FENOFIBRATE LUPIN LTD Labeling Approval
09/23/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-25 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #091602		 SUPPL-1 BIVALIRUDIN MEITHEAL Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #091602		 SUPPL-5 BIVALIRUDIN MEITHEAL Labeling Approval
09/23/2019 FENOFIBRIC ACID
ANDA #200264		 SUPPL-2 CHOLINE FENOFIBRATE IMPAX LABS INC Labeling Approval
09/23/2019 FENOFIBRIC ACID
ANDA #200264		 SUPPL-3 CHOLINE FENOFIBRATE IMPAX LABS INC Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #202471		 SUPPL-3 BIVALIRUDIN MYLAN INSTITUTIONAL Labeling Approval
09/23/2019 METAXALONE
ANDA #203399		 SUPPL-6 METAXALONE AMNEAL PHARMS Labeling Approval
09/23/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #204645		 SUPPL-9 TAMSULOSIN HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
09/23/2019 PALIPERIDONE
ANDA #204707		 ORIG-1 PALIPERIDONE AMNEAL PHARMS Approval
09/23/2019 METAXALONE
ANDA #204770		 SUPPL-4 METAXALONE LANNETT CO INC Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #205118		 SUPPL-3 FENOFIBRATE AUROBINDO PHARMA Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #205118		 SUPPL-5 FENOFIBRATE AUROBINDO PHARMA Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #205118		 SUPPL-8 FENOFIBRATE AUROBINDO PHARMA Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #205962		 SUPPL-1 BIVALIRUDIN EUGIA PHARMA Labeling Approval
09/23/2019 VALGANCICLOVIR HYDROCHLORIDE
ANDA #206876		 SUPPL-1 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS Labeling Approval
09/23/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SPECGX LLC Labeling Approval
09/23/2019 OXYBUTYNIN CHLORIDE
ANDA #207138		 SUPPL-5 OXYBUTYNIN CHLORIDE ACCORD HLTHCARE Labeling Approval
09/23/2019 TAMSULOSIN HYDROCHLORIDE
ANDA #207405		 SUPPL-3 TAMSULOSIN HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
09/23/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207510		 SUPPL-2 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WES PHARMA INC Labeling Approval
09/23/2019 NARCAN
NDA #208411		 SUPPL-2 NALOXONE HYDROCHLORIDE EMERGENT Manufacturing (CMC) Approval
09/23/2019 TESTOSTERONE
ANDA #209390		 ORIG-1 TESTOSTERONE TWI PHARMS Approval
09/23/2019 FENOFIBRATE
ANDA #209951		 SUPPL-1 FENOFIBRATE AMNEAL Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #209951		 SUPPL-2 FENOFIBRATE AMNEAL Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #209951		 SUPPL-3 FENOFIBRATE AMNEAL Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #210606		 SUPPL-1 FENOFIBRATE GRAVITI PHARMS Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #210606		 SUPPL-2 FENOFIBRATE GRAVITI PHARMS Labeling Approval
09/23/2019 SOLIFENACIN SUCCINATE
ANDA #210688		 SUPPL-1 SOLIFENACIN SUCCINATE MSN Labeling Approval
09/23/2019 LEVOCETIRIZINE HYDROCHLORIDE
ANDA #210914		 SUPPL-1 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Labeling Approval
09/24/2019 MANNITOL 10% IN PLASTIC CONTAINER
NDA #020006		 SUPPL-28 MANNITOL B BRAUN Efficacy Approval
09/24/2019 MANNITOL 15% IN PLASTIC CONTAINER
NDA #020006		 SUPPL-28 MANNITOL B BRAUN Efficacy Approval
09/24/2019 MANNITOL 20% IN PLASTIC CONTAINER
NDA #020006		 SUPPL-28 MANNITOL B BRAUN Efficacy Approval
09/24/2019 MANNITOL 5% IN PLASTIC CONTAINER
NDA #020006		 SUPPL-28 MANNITOL B BRAUN Efficacy Approval
09/24/2019 SOMAVERT
BLA #021106		 SUPPL-45 PEGVISOMANT PHARMACIA Approval
09/24/2019 ZEGERID
NDA #021636		 SUPPL-20 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
09/24/2019 ZEGERID
NDA #021849		 SUPPL-15 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
09/24/2019 VERAPAMIL HYDROCHLORIDE
ANDA #074587		 SUPPL-39 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
09/24/2019 VERAPAMIL HYDROCHLORIDE
ANDA #074587		 SUPPL-40 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
09/24/2019 VERAPAMIL HYDROCHLORIDE
ANDA #090529		 SUPPL-11 VERAPAMIL HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
09/24/2019 VERAPAMIL HYDROCHLORIDE
ANDA #090529		 SUPPL-13 VERAPAMIL HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
09/24/2019 SIMPONI
BLA #125289		 SUPPL-146 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
09/24/2019 SIMPONI ARIA
BLA #125433		 SUPPL-28 GOLIMUMAB JANSSEN BIOTECH Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-6 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-7 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-8 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-10 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-11 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 LAMIVUDINE
ANDA #202032		 SUPPL-13 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/24/2019 DONEPEZIL HYDROCHLORIDE
ANDA #203104		 SUPPL-5 DONEPEZIL HYDROCHLORIDE TWI PHARMS Labeling Approval
09/24/2019 CLOBETASOL PROPIONATE
ANDA #205249		 ORIG-1 CLOBETASOL PROPIONATE ZYDUS LIFESCIENCES Approval
09/24/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #206375		 SUPPL-1 LAMIVUDINE; ZIDOVUDINE ANDA REPOSITORY Labeling Approval
09/24/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #206375		 SUPPL-2 LAMIVUDINE; ZIDOVUDINE ANDA REPOSITORY Labeling Approval
09/24/2019 TREPROSTINIL
ANDA #209382		 ORIG-1 TREPROSTINIL PAR STERILE PRODUCTS Approval
09/24/2019 TALZENNA
NDA #211651		 SUPPL-2 TALAZOPARIB TOSYLATE PFIZER Efficacy Approval
09/25/2019 LAMICTAL
NDA #020241		 SUPPL-60 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
09/25/2019 FRAGMIN
NDA #020287		 SUPPL-60 DALTEPARIN SODIUM PFIZER Labeling Approval
09/25/2019 LAMICTAL CD
NDA #020764		 SUPPL-53 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
09/25/2019 EMEND
NDA #021549		 SUPPL-31 APREPITANT MERCK Labeling Approval
09/25/2019 TASIGNA
NDA #022068		 SUPPL-31 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
09/25/2019 LAMICTAL XR
NDA #022115		 SUPPL-26 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
09/25/2019 LAMICTAL ODT
NDA #022251		 SUPPL-24 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
09/25/2019 ACARBOSE
ANDA #077532		 SUPPL-8 ACARBOSE WATSON LABS Labeling Approval
09/25/2019 DYSPORT
BLA #125274		 SUPPL-115 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
09/25/2019 VERAPAMIL HYDROCHLORIDE
ANDA #206173		 SUPPL-1 VERAPAMIL HYDROCHLORIDE CADILA PHARMS LTD Labeling Approval
09/25/2019 EMEND
NDA #207865		 SUPPL-4 APREPITANT MSD MERCK CO Labeling Approval
09/25/2019 TRIENTINE HYDROCHLORIDE
ANDA #210096		 ORIG-1 TRIENTINE HYDROCHLORIDE PAR PHARM INC Approval
09/25/2019 ENTECAVIR
ANDA #212126		 ORIG-1 ENTECAVIR BRIGHTGENE Approval
09/26/2019 LISINOPRIL
ANDA #076164		 SUPPL-19 LISINOPRIL PRINSTON INC Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464		 SUPPL-13 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464		 SUPPL-14 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464		 SUPPL-16 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078306		 SUPPL-10 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078906		 SUPPL-7 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078906		 SUPPL-9 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #090457		 SUPPL-10 LAMIVUDINE STRIDES PHARMA Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #090457		 SUPPL-12 LAMIVUDINE STRIDES PHARMA Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #090700		 SUPPL-4 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #090700		 SUPPL-6 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
09/26/2019 WARFARIN SODIUM
ANDA #090935		 SUPPL-3 WARFARIN SODIUM INVAGEN PHARMS Labeling Approval
09/26/2019 WARFARIN SODIUM
ANDA #090935		 SUPPL-5 WARFARIN SODIUM INVAGEN PHARMS Labeling Approval
09/26/2019 WARFARIN SODIUM
ANDA #090935		 SUPPL-9 WARFARIN SODIUM INVAGEN PHARMS Labeling Approval
09/26/2019 TOPOTECAN HYDROCHLORIDE
ANDA #091199		 SUPPL-3 TOPOTECAN HYDROCHLORIDE TEYRO LABS Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #203277		 SUPPL-1 LAMIVUDINE HETERO LABS LTD V Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #203277		 SUPPL-2 LAMIVUDINE HETERO LABS LTD V Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #203277		 SUPPL-3 LAMIVUDINE HETERO LABS LTD V Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #203277		 SUPPL-4 LAMIVUDINE HETERO LABS LTD V Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #203277		 SUPPL-5 LAMIVUDINE HETERO LABS LTD V Labeling Approval
09/26/2019 CYCLOPHOSPHAMIDE
NDA #203856		 SUPPL-3 CYCLOPHOSPHAMIDE HIKMA Labeling Approval
09/26/2019 OMEPRAZOLE
ANDA #204012		 ORIG-1 OMEPRAZOLE HETERO LABS LTD III Approval
09/26/2019 TREPROSTINIL
ANDA #206648		 ORIG-1 TREPROSTINIL TEVA PHARMS USA Approval
09/26/2019 EZETIMIBE AND SIMVASTATIN
ANDA #208831		 SUPPL-2 EZETIMIBE; SIMVASTATIN AMNEAL PHARMS CO Labeling Approval
09/26/2019 EZETIMIBE AND SIMVASTATIN
ANDA #209222		 SUPPL-5 EZETIMIBE; SIMVASTATIN ALKEM LABS LTD Labeling Approval
09/26/2019 OLOPATADINE HYDROCHLORIDE
ANDA #209282		 ORIG-1 OLOPATADINE HYDROCHLORIDE FDC LTD Approval
09/26/2019 MAVYRET
NDA #209394		 SUPPL-7 GLECAPREVIR; PIBRENTASVIR ABBVIE Efficacy Approval
09/26/2019 MAVYRET
NDA #209394		 SUPPL-8 GLECAPREVIR; PIBRENTASVIR ABBVIE Efficacy Approval
09/26/2019 DOXERCALCIFEROL
ANDA #210452		 ORIG-1 DOXERCALCIFEROL GLAND PHARMA LTD Approval
09/26/2019 COPIKTRA
NDA #211155		 SUPPL-1 DUVELISIB SECURA Labeling Approval
09/26/2019 SOLIFENACIN SUCCINATE
ANDA #212214		 ORIG-1 SOLIFENACIN SUCCINATE STRIDES PHARMA Approval
09/26/2019 DARZALEX
BLA #761036		 SUPPL-24 DARATUMUMAB JANSSEN BIOTECH Approval
09/27/2019 WARFARIN SODIUM
ANDA #040301		 SUPPL-34 WARFARIN SODIUM TARO Labeling Approval
09/27/2019 WARFARIN SODIUM
ANDA #040301		 SUPPL-36 WARFARIN SODIUM TARO Labeling Approval
09/27/2019 WARFARIN SODIUM
ANDA #040301		 SUPPL-38 WARFARIN SODIUM TARO Labeling Approval
09/27/2019 RIFAMATE
ANDA #061884		 SUPPL-18 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
09/27/2019 RIFAMATE
ANDA #061884		 SUPPL-19 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
09/27/2019 RIFAMATE
ANDA #061884		 SUPPL-20 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
09/27/2019 RIFAMATE
ANDA #061884		 SUPPL-22 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
09/27/2019 RIFAMATE
ANDA #061884		 SUPPL-25 ISONIAZID; RIFAMPIN SANOFI AVENTIS US Labeling Approval
09/27/2019 VERAPAMIL HYDROCHLORIDE
ANDA #071483		 SUPPL-26 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
09/27/2019 VERAPAMIL HYDROCHLORIDE
ANDA #071483		 SUPPL-27 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072103		 SUPPL-30 DESIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/27/2019 VERAPAMIL HYDROCHLORIDE
ANDA #075138		 SUPPL-17 VERAPAMIL HYDROCHLORIDE MYLAN Labeling Approval
09/27/2019 MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #081309		 SUPPL-9 MEPERIDINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
09/27/2019 RITUXAN
BLA #103705		 SUPPL-5457 RITUXIMAB GENENTECH Approval
09/27/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #203864		 SUPPL-3 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
09/27/2019 INVOKANA
NDA #204042		 SUPPL-32 CANAGLIFLOZIN JANSSEN PHARMS Efficacy Approval
09/27/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204772		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Manufacturing (CMC) Approval
09/27/2019 DALFAMPRIDINE
ANDA #206811		 SUPPL-2 DALFAMPRIDINE AUROBINDO PHARMA Labeling Approval
09/27/2019 NUPLAZID
NDA #207318		 SUPPL-9 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
09/27/2019 METAXALONE
ANDA #207466		 SUPPL-5 METAXALONE SCIEGEN PHARMS INC Labeling Approval
09/27/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208682		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE MSN Manufacturing (CMC) Approval
09/27/2019 VOSEVI
NDA #209195		 SUPPL-4 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR GILEAD SCIENCES INC Labeling Approval
09/27/2019 DAPSONE
ANDA #209506		 SUPPL-1 DAPSONE TARO Labeling Approval
09/27/2019 IDHIFA
NDA #209606		 SUPPL-2 ENASIDENIB MESYLATE BRISTOL MYERS SQUIBB Labeling Approval
09/27/2019 NUPLAZID
NDA #210793		 SUPPL-3 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
09/27/2019 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
ANDA #211491		 ORIG-1 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE SUN PHARM INDS LTD Tentative Approval
09/27/2019 EMPAGLIFLOZIN
ANDA #212358		 ORIG-1 EMPAGLIFLOZIN MSN LABS PVT LTD Tentative Approval
09/27/2019 ABIRATERONE ACETATE
ANDA #212462		 ORIG-1 ABIRATERONE ACETATE QILU Approval
09/27/2019 CRYSVITA
BLA #761068		 SUPPL-3 BUROSUMAB-TWZA KYOWA KIRIN Approval
09/27/2019 CRYSVITA
BLA #761068		 SUPPL-4 BUROSUMAB-TWZA KYOWA KIRIN Approval
09/28/2019 AUVI-Q
NDA #201739		 SUPPL-15 EPINEPHRINE KALEO INC Labeling Approval
09/30/2019 NEXIUM IV
NDA #021689		 SUPPL-34 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
09/30/2019 FIBRICOR
NDA #022418		 SUPPL-16 FENOFIBRIC ACID ATHENA Labeling Approval
09/30/2019 TEMAZEPAM
ANDA #071620		 SUPPL-37 TEMAZEPAM ACTAVIS ELIZABETH Labeling Approval
09/30/2019 TEMAZEPAM
ANDA #071620		 SUPPL-38 TEMAZEPAM ACTAVIS ELIZABETH Labeling Approval
09/30/2019 LAMIVUDINE
ANDA #077221		 SUPPL-1 LAMIVUDINE CIPLA Labeling Approval
09/30/2019 LAMIVUDINE
ANDA #077221		 SUPPL-2 LAMIVUDINE CIPLA Labeling Approval
09/30/2019 LAMIVUDINE
ANDA #077221		 SUPPL-3 LAMIVUDINE CIPLA Labeling Approval
09/30/2019 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #201615		 SUPPL-9 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE CHARTWELL RX Labeling Approval
09/30/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #204963		 SUPPL-2 DESIPRAMINE HYDROCHLORIDE NOVAST LABS Labeling Approval
09/30/2019 VILAZODONE HYDROCHLORIDE
ANDA #208212		 ORIG-1 VILAZODONE HYDROCHLORIDE TEVA PHARMS USA Approval
09/30/2019 DESFLURANE
ANDA #208234		 SUPPL-4 DESFLURANE SHANGHAI HENGRUI Labeling Approval
09/30/2019 PREGABALIN
ANDA #210891		 ORIG-1 PREGABALIN YILING Approval
09/30/2019 ZULRESSO
NDA #211371		 SUPPL-3 BREXANOLONE SAGE THERAP REMS Approval
09/30/2019 EXTENDED PHENYTOIN SODIUM
ANDA #211633		 ORIG-1 PHENYTOIN SODIUM LUPIN LTD Approval
09/30/2019 POTASSIUM CHLORIDE
ANDA #212561		 ORIG-1 POTASSIUM CHLORIDE YICHANG HUMANWELL Approval
09/30/2019 GLYCOPYRROLATE
ANDA #212612		 ORIG-1 GLYCOPYRROLATE GLAND PHARMA LTD Approval
Back to Top