Drugs@FDA: FDA Approved Drug Products

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All Approvals
September 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on October 20, 2019.

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 #205347
SUPPL-1 VALSARTAN SQUARE PHARMS LTD Labeling Approval
09/03/2019 LATANOPROST
ANDA #206519
ORIG-1 LATANOPROST AUROBINDO PHARMA LTD 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 PHARMS LTD Labeling Approval
09/04/2019 LURASIDONE HYDROCHLORIDE
ANDA #208058
ORIG-1 LURASIDONE HYDROCHLORIDE EMCURE PHARMS LTD 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 USA INC Labeling Approval
09/05/2019 REMERON SOLTAB
NDA #021208
SUPPL-25 MIRTAZAPINE ORGANON USA INC 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 PADDOCK LLC 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 MYLAN 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 INC 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 PHARMA LTD Labeling Approval
09/05/2019 CASPOFUNGIN ACETATE
ANDA #207092
SUPPL-3 CASPOFUNGIN ACETATE GLAND PHARMA LTD 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 PHARMS 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 LABS PVT LTD Approval
09/05/2019 FOSAPREPITANT DIMEGLUMINE
NDA #210064
ORIG-1 FOSAPREPITANT 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 SUNGEN PHARMA 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 PHARMS 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 PFIZER Labeling Approval
09/06/2019 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113
SUPPL-8 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071427
SUPPL-30 TEMAZEPAM SANDOZ Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071427
SUPPL-31 TEMAZEPAM SANDOZ Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071428
SUPPL-30 TEMAZEPAM SANDOZ Labeling Approval
09/06/2019 TEMAZEPAM
ANDA #071428
SUPPL-31 TEMAZEPAM SANDOZ Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #074248
SUPPL-24 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 TOLMAR 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 PADDOCK LLC Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #090898
SUPPL-6 CLOBETASOL PROPIONATE PADDOCK LLC Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #090974
SUPPL-5 CLOBETASOL PROPIONATE PERRIGO 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 PERRIGO UK FINCO Labeling Approval
09/06/2019 CLOBETASOL PROPIONATE
ANDA #201402
SUPPL-13 CLOBETASOL PROPIONATE PERRIGO UK FINCO 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 INGENUS PHARMS LLC Labeling Approval
09/06/2019 MESNA
ANDA #206992
SUPPL-1 MESNA GLAND PHARMA LTD Labeling Approval
09/06/2019 MESNA
ANDA #206992
SUPPL-3 MESNA GLAND PHARMA LTD Labeling Approval
09/06/2019 DOCETAXEL
ANDA #207563
SUPPL-2 DOCETAXEL INGENUS PHARMS LLC Labeling Approval
09/06/2019 DOCETAXEL
ANDA #207563
SUPPL-4 DOCETAXEL INGENUS PHARMS LLC 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 TELIGENT PHARMA INC Labeling Approval
09/06/2019 COLCHICINE
ANDA #209876
ORIG-1 COLCHICINE DR REDDYS Approval
09/06/2019 FENOFIBRATE
ANDA #210670
ORIG-1 FENOFIBRATE NUVO PHARM 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 INC 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 #076397
SUPPL-7 PRAVASTATIN SODIUM APNAR PHARMA LP Labeling 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 EMCURE PHARMS LTD Manufacturing (CMC) Approval
09/09/2019 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #205397
ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE PERRIGO 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 ATLANTIS Labeling Approval
09/09/2019 MIBELAS 24 FE
ANDA #206287
SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN ATLANTIS Labeling Approval
09/09/2019 MIBELAS 24 FE
ANDA #206287
SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN ATLANTIS Manufacturing (CMC) Approval
09/09/2019 CELECOXIB
ANDA #206827
SUPPL-6 CELECOXIB AUROBINDO PHARMA LTD Labeling Approval
09/09/2019 IBRANCE
NDA #207103
SUPPL-11 PALBOCICLIB PFIZER INC Efficacy Approval
09/09/2019 IBRANCE
NDA #207103
SUPPL-12 PALBOCICLIB PFIZER INC 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 PHARMS LTD 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 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 TECHNOLOGIES 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 ACP NIMBLE Labeling Approval
09/11/2019 INDOMETHACIN
ANDA #073314
SUPPL-23 INDOMETHACIN ACP NIMBLE 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 LTD Labeling Approval
09/11/2019 FAMOTIDINE
ANDA #206531
SUPPL-7 FAMOTIDINE AUROBINDO PHARMA LTD 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 LABS LTD 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 SHIRE DEV LLC Efficacy Approval
09/13/2019 ANASTROZOLE
ANDA #091051
SUPPL-7 ANASTROZOLE MYLAN Labeling Approval
09/13/2019 VALSARTAN
ANDA #091367
SUPPL-5 VALSARTAN ALEMBIC PHARMS LTD Labeling Approval
09/13/2019 VALSARTAN
ANDA #091367
SUPPL-11 VALSARTAN ALEMBIC PHARMS LTD 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 ALLERGAN SALES LLC 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 INC 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 NORATECH 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 VGYAAN 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 PHARMACIA AND UPJOHN Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296
SUPPL-2 PANTOPRAZOLE SODIUM SANDOZ INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296
SUPPL-3 PANTOPRAZOLE SODIUM SANDOZ INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296
SUPPL-5 PANTOPRAZOLE SODIUM SANDOZ INC Labeling Approval
09/16/2019 PANTOPRAZOLE SODIUM
ANDA #090296
SUPPL-6 PANTOPRAZOLE SODIUM SANDOZ INC 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 KADMON PHARMS LLC 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 INGENUS PHARMS LLC 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 AUROBINDO PHARMA LTD Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675
SUPPL-5 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675
SUPPL-6 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675
SUPPL-8 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/17/2019 PANTOPRAZOLE SODIUM
ANDA #205675
SUPPL-11 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD 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 LABS PVT LTD 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 SANOFI US Labeling Approval
09/18/2019 ZANTAC 150
NDA #021698
SUPPL-31 RANITIDINE HYDROCHLORIDE SANOFI US 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 CADILA Labeling Approval
09/18/2019 INDOMETHACIN
ANDA #090403
SUPPL-5 INDOMETHACIN CADILA 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 PHARMS LTD Labeling Approval
09/18/2019 CELECOXIB
ANDA #204519
SUPPL-7 CELECOXIB ALEMBIC PHARMS LTD Labeling Approval
09/18/2019 OZOBAX
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
NDA #021106
SUPPL-64 PEGVISOMANT PHARMACIA AND UPJOHN Labeling 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 LUPIN LTD Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750
SUPPL-10 CHOLINE FENOFIBRATE LUPIN LTD Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750
SUPPL-11 CHOLINE FENOFIBRATE LUPIN LTD Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #200750
SUPPL-14 CHOLINE FENOFIBRATE LUPIN LTD 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 PHARMS LTD Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #208705
SUPPL-9 CHOLINE FENOFIBRATE ALEMBIC PHARMS LTD Labeling Approval
09/19/2019 FENOFIBRIC ACID
ANDA #208705
SUPPL-11 CHOLINE FENOFIBRATE ALEMBIC PHARMS LTD 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 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
ANDA #209610
ORIG-1 BENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATE PERRIGO UK FINCO Tentative 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 MERCK SHARP DOHME 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 MYLAN 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 PHARMA 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 INC Labeling Approval
09/20/2019 ATOVAQUONE
ANDA #209750
SUPPL-4 ATOVAQUONE APOTEX INC Labeling Approval
09/20/2019 CEQUA
NDA #210913
SUPPL-2 CYCLOSPORINE SUN PHARMA GLOBAL Labeling Approval
09/20/2019 RYBELSUS
NDA #213051
ORIG-1 SEMAGLUTIDE NOVO Type 3 - New Dosage Form 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 CIPLA Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #091602
SUPPL-5 BIVALIRUDIN CIPLA 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 LTD Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #205118
SUPPL-5 FENOFIBRATE AUROBINDO PHARMA LTD Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #205118
SUPPL-8 FENOFIBRATE AUROBINDO PHARMA LTD Labeling Approval
09/23/2019 BIVALIRUDIN
ANDA #205962
SUPPL-1 BIVALIRUDIN AUROBINDO PHARMA LTD 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 ADAPT 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 PHARMS LLC Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #209951
SUPPL-2 FENOFIBRATE AMNEAL PHARMS LLC Labeling Approval
09/23/2019 FENOFIBRATE
ANDA #209951
SUPPL-3 FENOFIBRATE AMNEAL PHARMS LLC 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 LABS PVT LTD 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 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 MYLAN Labeling Approval
09/24/2019 VERAPAMIL HYDROCHLORIDE
ANDA #074587
SUPPL-40 VERAPAMIL HYDROCHLORIDE MYLAN 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 PHARMS 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 INC Efficacy Approval
09/25/2019 LAMICTAL
NDA #020241
SUPPL-60 LAMOTRIGINE GLAXOSMITHKLINE LLC 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 LISINOPRIL
ANDA #076180
SUPPL-18 LISINOPRIL PRINSTON INC Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464
SUPPL-13 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464
SUPPL-14 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/26/2019 LAMIVUDINE
ANDA #077464
SUPPL-16 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078306
SUPPL-10 VERAPAMIL HYDROCHLORIDE MYLAN Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078906
SUPPL-7 VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #078906
SUPPL-9 VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS 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 GENERICS Labeling Approval
09/26/2019 VERAPAMIL HYDROCHLORIDE
ANDA #090700
SUPPL-6 VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS 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 CIPLA 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 WEST-WARD PHARMS INT 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 INC Efficacy Approval
09/26/2019 MAVYRET
NDA #209394
SUPPL-8 GLECAPREVIR; PIBRENTASVIR ABBVIE INC Efficacy Approval
09/26/2019 DOXERCALCIFEROL
ANDA #210452
ORIG-1 DOXERCALCIFEROL GLAND PHARMA LTD Approval
09/26/2019 COPIKTRA
NDA #211155
SUPPL-1 DUVELISIB VERASTEM INC 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 MYLAN Labeling Approval
09/27/2019 VERAPAMIL HYDROCHLORIDE
ANDA #071483
SUPPL-27 VERAPAMIL HYDROCHLORIDE MYLAN Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072099
SUPPL-37 DESIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072100
SUPPL-35 DESIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072101
SUPPL-36 DESIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072102
SUPPL-31 DESIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072103
SUPPL-30 DESIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
09/27/2019 DESIPRAMINE HYDROCHLORIDE
ANDA #072104
SUPPL-31 DESIPRAMINE HYDROCHLORIDE SANDOZ 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 CNTY LINE PHARMS Manufacturing (CMC) Approval
09/27/2019 DALFAMPRIDINE
ANDA #206811
SUPPL-2 DALFAMPRIDINE AUROBINDO PHARMA LTD 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 LABS PVT LTD 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 CELGENE CORP 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 DAPAGLIFLOZIN
ANDA #211523
ORIG-1 DAPAGLIFLOZIN AIZANT 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 PHARM CO LTD Approval
09/27/2019 CRYSVITA
BLA #761068
SUPPL-3 BUROSUMAB-TWZA ULTRAGENYX PHARM INC Approval
09/27/2019 CRYSVITA
BLA #761068
SUPPL-4 BUROSUMAB-TWZA ULTRAGENYX PHARM INC 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 PHARMS 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 TOLMAR 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 HAINAN Approval
09/30/2019 PREGABALIN
ANDA #211177
ORIG-1 PREGABALIN ALKEM LABS LTD 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
09/30/2019 PIRFENIDONE
ANDA #212709
ORIG-1 PIRFENIDONE APOTEX INC Tentative Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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