Drugs@FDA: FDA Approved Drug Products

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All Approvals
April 2018

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 April 26, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/2018 LINCOCIN
NDA #050317		 SUPPL-184 LINCOMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
04/02/2018 ULTRAVIST 150
NDA #020220		 SUPPL-45 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 ULTRAVIST 240
NDA #020220		 SUPPL-45 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 ULTRAVIST 300
NDA #020220		 SUPPL-45 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220		 SUPPL-45 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 ULTRAVIST 370
NDA #020220		 SUPPL-45 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 ULTRAVIST (PHARMACY BULK)
NDA #021425		 SUPPL-28 IOPROMIDE BAYER HLTHCARE Labeling Approval
04/02/2018 XYZAL
NDA #022064		 SUPPL-36 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI-AVENTIS US Labeling Approval
04/02/2018 XYZAL
NDA #022157		 SUPPL-18 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI-AVENTIS US Labeling Approval
04/02/2018 BYDUREON
NDA #022200		 SUPPL-26 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
04/02/2018 BYDUREON PEN
NDA #022200		 SUPPL-26 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
04/02/2018 AMLODIPINE BESYLATE
ANDA #076719		 SUPPL-11 AMLODIPINE BESYLATE APOTEX Labeling Approval
04/02/2018 AMLODIPINE BESYLATE
ANDA #077262		 SUPPL-6 AMLODIPINE BESYLATE WEST-WARD PHARMS INT Labeling Approval
04/02/2018 AMLODIPINE BESYLATE
ANDA #078414		 SUPPL-13 AMLODIPINE BESYLATE VINTAGE Labeling Approval
04/02/2018 AMLODIPINE BESYLATE
ANDA #202553		 SUPPL-1 AMLODIPINE BESYLATE ACCORD HLTHCARE Labeling Approval
04/02/2018 AMLODIPINE BESYLATE
ANDA #202553		 SUPPL-2 AMLODIPINE BESYLATE ACCORD HLTHCARE Labeling Approval
04/02/2018 STRIVERDI RESPIMAT
NDA #203108		 SUPPL-6 OLODATEROL HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
04/03/2018 FLAGYL
NDA #012623		 SUPPL-67 METRONIDAZOLE GD SEARLE LLC Labeling Approval
04/03/2018 METRONIDAZOLE IN PLASTIC CONTAINER
NDA #018890		 SUPPL-52 METRONIDAZOLE HOSPIRA Labeling Approval
04/03/2018 FLAGYL
NDA #020334		 SUPPL-10 METRONIDAZOLE GD SEARLE LLC Labeling Approval
04/03/2018 FLAGYL ER
NDA #020868		 SUPPL-12 METRONIDAZOLE GD SEARLE LLC Labeling Approval
04/03/2018 PRILOSEC OTC
NDA #021229		 SUPPL-31 OMEPRAZOLE MAGNESIUM ASTRAZENECA PHARMS Labeling Approval
04/03/2018 EMEND
NDA #022023		 SUPPL-17 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Efficacy Approval
04/03/2018 BESIVANCE
NDA #022308		 SUPPL-13 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Labeling Approval
04/03/2018 AMLODIPINE BESYLATE
ANDA #076418		 SUPPL-20 AMLODIPINE BESYLATE MYLAN PHARMS INC Labeling Approval
04/03/2018 AMLODIPINE BESYLATE
ANDA #077974		 SUPPL-4 AMLODIPINE BESYLATE SUN PHARM INDS LTD Labeling Approval
04/03/2018 AMLODIPINE BESYLATE
ANDA #077974		 SUPPL-5 AMLODIPINE BESYLATE SUN PHARM INDS LTD Labeling Approval
04/03/2018 RITUXAN
BLA #103705		 SUPPL-5453 RITUXIMAB GENENTECH Approval
04/03/2018 AMLODIPINE BESYLATE
ANDA #201380		 SUPPL-7 AMLODIPINE BESYLATE MACLEODS PHARMS LTD Labeling Approval
04/04/2018 TAMIFLU
NDA #021087		 SUPPL-69 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
04/04/2018 TAMIFLU
NDA #021246		 SUPPL-52 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
04/04/2018 ACITRETIN
ANDA #091455		 SUPPL-12 ACITRETIN BARR LABS INC Labeling Approval
04/04/2018 ACITRETIN
ANDA #202897		 SUPPL-12 ACITRETIN TEVA PHARMS USA Labeling Approval
04/04/2018 ROCURONIUM BROMIDE
ANDA #205656		 ORIG-1 ROCURONIUM BROMIDE GLAND CHEMS PVT Approval
04/04/2018 TESTOSTERONE CYPIONATE
ANDA #207742		 SUPPL-1 TESTOSTERONE CYPIONATE LUITPOLD PHARMS INC Manufacturing (CMC) Approval
04/05/2018 FEMARA
NDA #020726		 SUPPL-35 LETROZOLE NOVARTIS PHARMS Labeling Approval
04/05/2018 NALLPEN IN PLASTIC CONTAINER
NDA #050655		 SUPPL-26 NAFCILLIN SODIUM BAXTER HLTHCARE Labeling Approval
04/05/2018 AMLODIPINE BESYLATE
ANDA #078477		 SUPPL-19 AMLODIPINE BESYLATE AMNEAL PHARMS NY Labeling Approval
04/05/2018 CICLOPIROX
ANDA #209975		 ORIG-1 CICLOPIROX TELIGENT PHARMA INC Approval
04/06/2018 OFIRMEV
NDA #022450		 SUPPL-11 ACETAMINOPHEN MALLINCKRODT IP Labeling Approval
04/06/2018 EXPAREL
NDA #022496		 SUPPL-9 BUPIVACAINE PACIRA PHARMS INC Efficacy Approval
04/06/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040419		 SUPPL-21 ACETAMINOPHEN; CODEINE PHOSPHATE SPECGX LLC Labeling Approval
04/06/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040419		 SUPPL-23 ACETAMINOPHEN; CODEINE PHOSPHATE SPECGX LLC Labeling Approval
04/06/2018 IBANDRONATE SODIUM
ANDA #202671		 SUPPL-2 IBANDRONATE SODIUM MYLAN LABS LTD Manufacturing (CMC) Approval
04/06/2018 IBANDRONATE SODIUM
ANDA #202671		 SUPPL-4 IBANDRONATE SODIUM MYLAN LABS LTD Labeling Approval
04/06/2018 PALIPERIDONE
ANDA #205618		 ORIG-1 PALIPERIDONE SUN PHARMA GLOBAL Approval
04/06/2018 ACYCLOVIR
ANDA #209000		 ORIG-1 ACYCLOVIR ALEMBIC PHARMS LTD Approval
04/06/2018 RUBRACA
NDA #209115		 SUPPL-3 RUCAPARIB CAMSYLATE CLOVIS ONCOLOGY INC Efficacy Approval
04/06/2018 CLOBAZAM
ANDA #209718		 ORIG-1 CLOBAZAM AMNEAL PHARMS CO Tentative Approval
04/09/2018 PFIZERPEN
ANDA #060657		 SUPPL-28 PENICILLIN G POTASSIUM PFIZER Labeling Approval
04/09/2018 CEFPROZIL
ANDA #065208		 SUPPL-7 CEFPROZIL TEVA Labeling Approval
04/09/2018 CEFPROZIL
ANDA #065261		 SUPPL-15 CEFPROZIL LUPIN Labeling Approval
04/09/2018 CEFPROZIL
ANDA #065267		 SUPPL-7 CEFPROZIL ORCHID HLTHCARE Labeling Approval
04/09/2018 CEFPROZIL
ANDA #065276		 SUPPL-9 CEFPROZIL LUPIN Labeling Approval
04/09/2018 CEFPROZIL
ANDA #065284		 SUPPL-12 CEFPROZIL ORCHID HLTHCARE Labeling Approval
04/09/2018 CLOZAPINE
ANDA #090308		 ORIG-2 CLOZAPINE BARR LABS INC Approval
04/09/2018 VALSARTAN
ANDA #205347		 ORIG-1 VALSARTAN SQUARE PHARMS LTD Approval
04/09/2018 LIDOCAINE
ANDA #206297		 SUPPL-7 LIDOCAINE AMNEAL PHARMS Labeling Approval
04/09/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN PHARMS INC Approval
04/09/2018 AZITHROMYCIN
ANDA #207531		 ORIG-1 AZITHROMYCIN EPIC PHARMA LLC Approval
04/09/2018 POLYETHYLENE GLYCOL 3350
ANDA #209017		 ORIG-1 POLYETHYLENE GLYCOL 3350 AUROBINDO PHARMA LTD Approval
04/09/2018 MYLOTARG
BLA #761060		 SUPPL-1 GEMTUZUMAB OZOGAMICIN WYETH PHARMS INC Approval
04/10/2018 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-62 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE MERCK SHARP DOHME Labeling Approval
04/10/2018 AFINITOR
NDA #022334		 SUPPL-40 EVEROLIMUS NOVARTIS Efficacy Approval
04/10/2018 BLINCYTO
BLA #125557		 SUPPL-14 BLINATUMOMAB AMGEN Approval
04/10/2018 AFINITOR DISPERZ
NDA #203985		 SUPPL-13 EVEROLIMUS NOVARTIS PHARM Efficacy Approval
04/10/2018 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
ANDA #205078		 ORIG-1 METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE SUN PHARMA GLOBAL Tentative Approval
04/10/2018 LAMIVUDINE AND ZIDOVUDINE
ANDA #206375		 ORIG-1 LAMIVUDINE; ZIDOVUDINE SHANGHAI DESANO Approval
04/10/2018 DOFETILIDE
ANDA #208625		 ORIG-1 DOFETILIDE APICORE US Approval
04/10/2018 DUPIXENT
BLA #761055		 SUPPL-3 DUPILUMAB REGENERON PHARMACEUTICALS Approval
04/11/2018 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-35 METRONIDAZOLE B BRAUN Labeling Approval
04/11/2018 SEMPREX-D
NDA #019806		 SUPPL-13 ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE AUXILIUM PHARMS LLC Labeling Approval
04/11/2018 IBUPROFEN
ANDA #079174		 SUPPL-10 IBUPROFEN GRANULES INDIA Manufacturing (CMC) Approval
04/11/2018 IBUPROFEN
ANDA #079174		 SUPPL-14 IBUPROFEN GRANULES INDIA Labeling Approval
04/11/2018 DOCETAXEL
NDA #203551		 SUPPL-5 DOCETAXEL ACTAVIS LLC Labeling Approval
04/11/2018 DAPTOMYCIN
ANDA #206077		 ORIG-1 DAPTOMYCIN FRESENIUS KABI USA Approval
04/11/2018 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #207455		 ORIG-1 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE PRINSTON INC Approval
04/11/2018 DOPAMINE HYDROCHLORIDE
ANDA #207707		 ORIG-1 DOPAMINE HYDROCHLORIDE HIKMA INTL PHARMS Approval
04/11/2018 LORATADINE
ANDA #208477		 ORIG-1 LORATADINE AUROBINDO PHARMA LTD Approval
04/11/2018 CYPROHEPTADINE HYDROCHLORIDE
ANDA #209172		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE STRIDES PHARMA Approval
04/11/2018 FLAC
ANDA #210736		 ORIG-1 FLUOCINOLONE ACETONIDE PATRIN PHARMA INC Approval
04/12/2018 ADVIL
NDA #201803		 SUPPL-11 IBUPROFEN SODIUM PFIZER CONS HLTHCARE Labeling Approval
04/12/2018 SYNDROS
NDA #205525		 SUPPL-5 DRONABINOL INSYS DEV CO INC Labeling Approval
04/12/2018 EVEROLIMUS
ANDA #206133		 ORIG-1 EVEROLIMUS WEST-WARD PHARMS INT Approval
04/12/2018 NETSPOT
NDA #208547		 SUPPL-11 GALLIUM DOTATATE GA-68 AAA USA INC Labeling Approval
04/12/2018 PRAXBIND
BLA #761025		 SUPPL-2 IDARUCIZUMAB BOEHRINGER INGELHEIM Approval
04/13/2018 ANTIVERT
NDA #010721		 SUPPL-61 MECLIZINE HYDROCHLORIDE CASPER PHARMA LLC Efficacy Approval
04/13/2018 PREVACID
NDA #020406		 SUPPL-84 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
04/13/2018 DEFINITY
NDA #021064		 SUPPL-21 PERFLUTREN LANTHEUS MEDCL Manufacturing (CMC) Approval
04/13/2018 PREVACID
NDA #021428		 SUPPL-32 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
04/13/2018 NULOJIX
BLA #125288		 SUPPL-75 BELATACEPT BRISTOL MYERS SQUIBB Approval
04/13/2018 VARUBI
NDA #206500		 SUPPL-3 ROLAPITANT HYDROCHLORIDE TESARO INC Labeling Approval
04/13/2018 VIBERZI
NDA #206940		 SUPPL-3 ELUXADOLINE ALLERGAN HOLDINGS Labeling Approval
04/13/2018 VARUBI
NDA #208399		 SUPPL-2 ROLAPITANT HYDROCHLORIDE TESARO INC Labeling Approval
04/13/2018 TESTOSTERONE
ANDA #208560		 ORIG-1 TESTOSTERONE LUPIN ATLANTIS Tentative Approval
04/13/2018 PRAVASTATIN SODIUM
ANDA #209869		 ORIG-1 PRAVASTATIN SODIUM APPCO PHARMA LLC Approval
04/13/2018 KEVZARA
BLA #761037		 SUPPL-1 SARILUMAB SANOFI SYNTHELABO Approval
04/16/2018 TAZORAC
NDA #020600		 SUPPL-10 TAZAROTENE ALLERGAN Labeling Approval
04/16/2018 TYGACIL
NDA #021821		 SUPPL-45 TIGECYCLINE PF PRISM CV Labeling Approval
04/16/2018 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-79 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
04/16/2018 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-38 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090108		 SUPPL-5 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090108		 SUPPL-6 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090108		 SUPPL-9 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090108		 SUPPL-10 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090109		 SUPPL-7 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090109		 SUPPL-8 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090109		 SUPPL-11 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #090109		 SUPPL-12 CLINDAMYCIN PHOSPHATE SAGENT PHARMS Labeling Approval
04/16/2018 YERVOY
BLA #125377		 SUPPL-94 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
04/16/2018 OPDIVO
BLA #125554		 SUPPL-58 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
04/16/2018 ADENOSINE
ANDA #205568		 ORIG-1 ADENOSINE FRESENIUS KABI USA Approval
04/16/2018 LORATADINE
ANDA #208314		 ORIG-1 LORATADINE AUROBINDO PHARMA LTD Approval
04/16/2018 ERTAPENEM SODIUM
ANDA #208790		 ORIG-1 ERTAPENEM SODIUM ACS DOBFAR SPA Approval
04/16/2018 LORATADINE
ANDA #210088		 ORIG-1 LORATADINE SUN PHARMA GLOBAL Approval
04/16/2018 TACROLIMUS
ANDA #210393		 ORIG-1 TACROLIMUS GLENMARK PHARMS LTD Approval
04/17/2018 CARNITOR
NDA #018948		 SUPPL-28 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
04/17/2018 OMNIPAQUE 140
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 180
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 210
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 240
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 300
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 350
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 OMNIPAQUE 70
NDA #018956		 SUPPL-101 IOHEXOL GE HEALTHCARE Labeling Approval
04/17/2018 CARNITOR
NDA #019257		 SUPPL-14 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
04/17/2018 CARNITOR SF
NDA #019257		 SUPPL-14 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
04/17/2018 CARNITOR
NDA #020182		 SUPPL-15 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
04/17/2018 ALIMTA
NDA #021462		 SUPPL-52 PEMETREXED DISODIUM LILLY Labeling Approval
04/17/2018 EVOCLIN
NDA #050801		 SUPPL-18 CLINDAMYCIN PHOSPHATE MYLAN PHARMS INC Labeling Approval
04/17/2018 IRBESARTAN
ANDA #204740		 ORIG-1 IRBESARTAN AMNEAL PHARMS Approval
04/17/2018 MORPHINE SULFATE
ANDA #205509		 ORIG-1 MORPHINE SULFATE ANI PHARMS INC Approval
04/17/2018 DICLOFENAC SODIUM
ANDA #206411		 ORIG-1 DICLOFENAC SODIUM ZYDUS PHARMS USA INC Approval
04/17/2018 TRANYLCYPROMINE SULFATE
ANDA #206856		 ORIG-1 TRANYLCYPROMINE SULFATE KINEDEXE UK Approval
04/17/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #207806		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE PRINSTON INC Approval
04/17/2018 MIGLUSTAT
ANDA #208342		 ORIG-1 MIGLUSTAT AMERIGEN PHARMS LTD Approval
04/17/2018 DOXAZOSIN MESYLATE
ANDA #209013		 ORIG-1 DOXAZOSIN MESYLATE APPCO PHARMA LLC Approval
04/17/2018 IBUPROFEN
ANDA #209179		 ORIG-1 IBUPROFEN AUROBINDO PHARMA LTD Approval
04/17/2018 TAVALISSE
NDA #209299		 ORIG-1 FOSTAMATINIB RIGEL PHARMS INC Type 1 - New Molecular Entity Approval
04/17/2018 METHOCARBAMOL
ANDA #209331		 ORIG-1 METHOCARBAMOL FRESENIUS KABI USA Approval
04/17/2018 CLOBETASOL PROPIONATE
ANDA #209701		 ORIG-1 CLOBETASOL PROPIONATE CHEMO RESEARCH SL Approval
04/17/2018 SILODOSIN
ANDA #209745		 ORIG-1 SILODOSIN AMNEAL PHARMS CO Tentative Approval
04/17/2018 CLOBETASOL PROPIONATE
ANDA #209974		 ORIG-1 CLOBETASOL PROPIONATE TELIGENT PHARMA INC Approval
04/17/2018 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #210375		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
04/17/2018 CLOBETASOL PROPIONATE
ANDA #210446		 ORIG-1 CLOBETASOL PROPIONATE APOTEX INC Approval
04/17/2018 CAPECITABINE
ANDA #210604		 ORIG-1 CAPECITABINE EUGIA PHARMA Approval
04/17/2018 SODIUM NITROPRUSSIDE
ANDA #210763		 ORIG-1 SODIUM NITROPRUSSIDE MYLAN LABS LTD Approval
04/17/2018 CRYSVITA
BLA #761068		 ORIG-1 BUROSUMAB-TWZA ULTRAGENYX PHARM INC Approval
04/18/2018 LUPRON DEPOT
NDA #020708		 SUPPL-35 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
04/18/2018 GLUCAGEN
NDA #020918		 SUPPL-49 GLUCAGON HYDROCHLORIDE RECOMBINANT NOVO NORDISK Labeling Approval
04/18/2018 GLUCAGON
NDA #020928		 SUPPL-55 GLUCAGON RECOMBINANT LILLY Labeling Approval
04/18/2018 ADVIL PM
NDA #021394		 SUPPL-25 DIPHENHYDRAMINE CITRATE; IBUPROFEN PFIZER Labeling Approval
04/18/2018 REYATAZ
NDA #021567		 SUPPL-42 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
04/18/2018 ASACOL HD
NDA #021830		 SUPPL-12 MESALAMINE APIL Labeling Approval
04/18/2018 CLARITIN
NDA #021952		 SUPPL-14 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
04/18/2018 TYSABRI
BLA #125104		 SUPPL-960 NATALIZUMAB BIOGEN IDEC Approval
04/18/2018 TYSABRI
BLA #125104		 SUPPL-963 NATALIZUMAB BIOGEN IDEC Approval
04/18/2018 TREPROSTINIL
ANDA #203649		 SUPPL-1 TREPROSTINIL SANDOZ INC Manufacturing (CMC) Approval
04/18/2018 REYATAZ
NDA #206352		 SUPPL-7 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
04/18/2018 EVOTAZ
NDA #206353		 SUPPL-5 ATAZANAVIR SULFATE; COBICISTAT BRISTOL-MYERS SQUIBB Labeling Approval
04/18/2018 ARIPIPRAZOLE
ANDA #207240		 ORIG-1 ARIPIPRAZOLE SCIEGEN PHARMS INC Approval
04/18/2018 LIDOCAINE HYDROCHLORIDE
ANDA #208017		 ORIG-1 LIDOCAINE HYDROCHLORIDE SPECTRA MDCL DEVICES Approval
04/18/2018 TAGRISSO
NDA #208065		 SUPPL-8 OSIMERTINIB MESYLATE ASTRAZENECA PHARMS Efficacy Approval
04/18/2018 TAGRISSO
NDA #208065		 SUPPL-9 OSIMERTINIB MESYLATE ASTRAZENECA PHARMS Labeling Approval
04/18/2018 CLOBETASOL PROPIONATE
ANDA #210190		 ORIG-1 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Approval
04/18/2018 ECONAZOLE NITRATE
ANDA #210364		 ORIG-1 ECONAZOLE NITRATE MYLAN PHARMS INC Approval
04/19/2018 HIBISTAT
NDA #018300		 SUPPL-19 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Labeling Approval
04/19/2018 LEVULAN
NDA #020965		 SUPPL-16 AMINOLEVULINIC ACID HYDROCHLORIDE DUSA Labeling Approval
04/19/2018 CLARINEX-D 12 HOUR
NDA #021313		 SUPPL-10 DESLORATADINE; PSEUDOEPHEDRINE SULFATE MERCK SHARP DOHME Labeling Approval
04/19/2018 CLARINEX D 24 HOUR
NDA #021605		 SUPPL-13 DESLORATADINE; PSEUDOEPHEDRINE SULFATE MERCK SHARP DOHME Labeling Approval
04/19/2018 UNASYN
NDA #050608		 SUPPL-46 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
04/19/2018 LAMIVUDINE
ANDA #090457		 ORIG-1 LAMIVUDINE STRIDES PHARMA Approval
04/19/2018 ACITRETIN
ANDA #091455		 SUPPL-10 ACITRETIN BARR LABS INC Labeling Approval
04/19/2018 TALTZ
BLA #125521		 SUPPL-2 IXEKIZUMAB ELI LILLY AND CO Approval
04/19/2018 ACITRETIN
ANDA #202552		 SUPPL-4 ACITRETIN IMPAX LABS INC Labeling Approval
04/19/2018 ACITRETIN
ANDA #202897		 SUPPL-10 ACITRETIN TEVA PHARMS USA Labeling Approval
04/19/2018 ACITRETIN
ANDA #204633		 SUPPL-4 ACITRETIN SIGMAPHARM LABS LLC Labeling Approval
04/19/2018 SOOLANTRA
NDA #206255		 SUPPL-4 IVERMECTIN GALDERMA LABS LP Labeling Approval
04/19/2018 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #207442		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE SOMERSET THERAPS LLC Approval
04/19/2018 AKYNZEO
NDA #210493		 ORIG-1 FOSNETUPITANT;PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Type 1 - New Molecular Entity Approval
04/20/2018 FENOFIBRATE
ANDA #076509		 SUPPL-26 FENOFIBRATE IMPAX LABS Labeling Approval
04/20/2018 AMLODIPINE BESYLATE
ANDA #077073		 SUPPL-15 AMLODIPINE BESYLATE CIPLA LTD Labeling Approval
04/20/2018 AMLODIPINE BESYLATE
ANDA #077073		 SUPPL-16 AMLODIPINE BESYLATE CIPLA LTD Labeling Approval
04/20/2018 AMLODIPINE BESYLATE
ANDA #077955		 SUPPL-14 AMLODIPINE BESYLATE INVAGEN PHARMS Labeling Approval
04/20/2018 TAFINLAR
NDA #202806		 SUPPL-9 DABRAFENIB MESYLATE NOVARTIS PHARMS CORP Labeling Approval
04/20/2018 BLEOMYCIN SULFATE
ANDA #205030		 ORIG-1 BLEOMYCIN SULFATE HONG KONG Approval
04/20/2018 PALONOSETRON HYDROCHLORIDE
ANDA #205870		 ORIG-1 PALONOSETRON HYDROCHLORIDE SAGENT PHARMS Tentative Approval
04/20/2018 FERRIPROX
NDA #208030		 SUPPL-2 DEFERIPRONE APOPHARMA INC Efficacy Approval
04/20/2018 MICAFUNGIN
ANDA #208366		 ORIG-1 MICAFUNGIN APOTEX INC Tentative Approval
04/20/2018 TETRABENAZINE
ANDA #210544		 ORIG-1 TETRABENAZINE LUPIN LTD Approval
04/23/2018 DECADRON
NDA #011664		 SUPPL-65 DEXAMETHASONE MERCK Labeling Approval
04/23/2018 ABSORICA
NDA #021951		 SUPPL-12 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
04/23/2018 SAMSCA
NDA #022275		 SUPPL-16 TOLVAPTAN OTSUKA AMERICA PHARM Labeling Approval
04/23/2018 E.E.S.
NDA #050207		 SUPPL-74 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
04/23/2018 ERYPED
NDA #050207		 SUPPL-74 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
04/23/2018 ERYC
NDA #050536		 SUPPL-26 ERYTHROMYCIN MAYNE PHARMA Labeling Approval
04/23/2018 ERYTHROCIN
NDA #050609		 SUPPL-39 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
04/23/2018 PCE
NDA #050611		 SUPPL-36 ERYTHROMYCIN ARBOR PHARMS LLC Labeling Approval
04/23/2018 CLONAZEPAM
ANDA #074979		 SUPPL-25 CLONAZEPAM SANDOZ Manufacturing (CMC) Approval
04/23/2018 ETOPOSIDE
ANDA #075635		 SUPPL-13 ETOPOSIDE MYLAN Labeling Approval
04/23/2018 AMNESTEEM
ANDA #075945		 SUPPL-36 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
04/23/2018 CLARAVIS
ANDA #076135		 SUPPL-42 ISOTRETINOIN TEVA PHARMS USA REMS Approval
04/23/2018 CLARAVIS
ANDA #076356		 SUPPL-39 ISOTRETINOIN TEVA PHARMS USA REMS Approval
04/23/2018 MYORISAN
ANDA #076485		 SUPPL-19 ISOTRETINOIN DOUGLAS PHARMS REMS Approval
04/23/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077009		 SUPPL-11 ONDANSETRON HYDROCHLORIDE TARO Labeling Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #077516		 SUPPL-4 AMLODIPINE BESYLATE VIVIMED GLOBAL Labeling Approval
04/23/2018 GABAPENTIN
ANDA #078787		 SUPPL-16 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
04/23/2018 GABAPENTIN
ANDA #078787		 SUPPL-17 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
04/23/2018 GABAPENTIN
ANDA #078787		 SUPPL-20 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
04/23/2018 GABAPENTIN
ANDA #078787		 SUPPL-22 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
04/23/2018 GABAPENTIN
ANDA #078787		 SUPPL-25 GABAPENTIN AUROBINDO PHARMA LTD Manufacturing (CMC) Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #090752		 SUPPL-3 AMLODIPINE BESYLATE CHINA RESOURCES Labeling Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #090752		 SUPPL-4 AMLODIPINE BESYLATE CHINA RESOURCES Labeling Approval
04/23/2018 ZENATANE
ANDA #202099		 SUPPL-12 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
04/23/2018 JYNARQUE
NDA #204441		 ORIG-1 TOLVAPTAN OTSUKA PHARM CO LTD Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #206367		 SUPPL-3 AMLODIPINE BESYLATE INVAGEN PHARMS Labeling Approval
04/23/2018 METHYLPREDNISOLONE
ANDA #206751		 ORIG-1 METHYLPREDNISOLONE ZYDUS PHARMS USA INC Approval
04/23/2018 ISOTRETINOIN
ANDA #207792		 SUPPL-3 ISOTRETINOIN AMNEAL PHARMS NY REMS Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #207821		 SUPPL-1 AMLODIPINE BESYLATE POLYGEN PHARMS Labeling Approval
04/23/2018 AMLODIPINE BESYLATE
ANDA #207821		 SUPPL-2 AMLODIPINE BESYLATE POLYGEN PHARMS Labeling Approval
04/23/2018 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #208369		 SUPPL-1 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
04/23/2018 CINACALCET HYDROCHLORIDE
ANDA #208971		 ORIG-1 CINACALCET HYDROCHLORIDE ZYDUS PHARMS USA INC Approval
04/23/2018 FLUOCINONIDE
ANDA #209118		 ORIG-1 FLUOCINONIDE GLASSHOUSE PHARMS Approval
04/23/2018 FLUOCINONIDE
ANDA #209283		 ORIG-1 FLUOCINONIDE MACLEODS PHARMS LTD Approval
04/23/2018 VIGABATRIN
ANDA #209824		 ORIG-1 VIGABATRIN TEVA PHARMS USA Approval
04/23/2018 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935		 SUPPL-1 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS PHARMS CORP Labeling Approval
04/24/2018 MIRALAX
NDA #022015		 SUPPL-29 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
04/24/2018 AFREZZA
NDA #022472		 SUPPL-17 INSULIN RECOMBINANT HUMAN MANNKIND REMS Approval
04/24/2018 TRELEGY ELLIPTA
NDA #209482		 SUPPL-1 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Efficacy Approval
04/25/2018 COLESTID
NDA #017563		 SUPPL-24 COLESTIPOL HYDROCHLORIDE PHARMACIA UPJOHN Labeling Approval
04/25/2018 FLAVORED COLESTID
NDA #017563		 SUPPL-24 COLESTIPOL HYDROCHLORIDE PHARMACIA UPJOHN Labeling Approval
04/25/2018 LOPID
NDA #018422		 SUPPL-58 GEMFIBROZIL PFIZER PHARMS Labeling Approval
04/25/2018 OLUX
NDA #021142		 SUPPL-22 CLOBETASOL PROPIONATE MYLAN PHARMS INC Labeling Approval
04/25/2018 AEROSPAN HFA
NDA #021247		 SUPPL-17 FLUNISOLIDE MYLAN SPECIALITY LP Labeling Approval
04/25/2018 VELPHORO
NDA #205109		 SUPPL-6 SUCROFERRIC OXYHYDROXIDE VIFOR FRESENIUS Labeling 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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