DMF#STATUSTYPESUBMIT DATEHOLDERSUBJECT
29889AII10/6/2015OPTIMUS DRUGS PRIVATE LTD(R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE)
29890AII10/6/2015OPTIMUS DRUGS PRIVATE LTD(R)-5-BROMO-3-[(1-METHYL-2-PYRROLIDINYL)METHYL]-1H-INDOLE (ELETRIPTAN INTERMEDIATE)
30039AII12/9/2015PPM SERVICES SA(S)-(-)-3-(4-AMINOPHENYL)-2-METHOXYPROPIONIC ACID
29993AII11/5/2015YALE UNIVERSITY PET CENTER[18F] FMISO
29783AII12/30/2015JOHNSON MATTHEY PHARMA SERVICES686.B
29538AII10/7/2015GE HEALTHCAREACTICHO MEDIA SYSTEM
30093AII12/30/2015ALEMBIC PHARMACEUTICALS LTDALOGLIPTIN BENZOATE
29917AII10/6/2015PROCOS SPAALVERINE CITRATE
29877AII11/6/2015AMGEN INCAMG 191 CELL LINE DEVELOPMENT
29883AII11/6/2015AMGEN INCAMG 191 DRUG PRODUCT
29873AII11/6/2015AMGEN INCAMG 191 DRUG SUBSTANCE
29743AII11/30/2015SPECTRUM PHARMACEUTICALS INCAPAZIQUONE
30060AII12/31/2015GLENMARK PHARMACEUTICALS LTDAPIXABAN
29991AII11/4/2015SMS PHARMACEUTICALS LTDARIPIPRAZOLE USP
30120AII12/14/2015ZCL CHEMICALS LTDARIPIPRAZOLE USP
29793AII10/12/2015SHANDONG XINHUA PHARMACEUTICAL CO LTDASPIRIN DC-90
29852AII12/17/2015RAKS PHARMA PVT LTDATAZANAVIR SULFATE
29971AII11/23/2015AMRI INDIA PVT LTDATENOLOL USP DRUG SUBSTANCE
29868AII10/31/2015MSN ORGANICS PRIVATE LTDATOMOXETINE HYDROCHLORIDE USP [ROUTE CODE "MY"]
29803AII9/24/2015RESONANCE LABORATORIES PVT LTDATROPINE SULFATE
29605AII7/30/2015SAURAV CHEMICALS LTDATROPINE SULFATE USP
30024AII12/15/2015HONOUR LAB LTDAVANAFIL
29918AII8/24/2015ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDAXITINIB
29484AII12/1/2015TARO PHARMACEUTICAL INDUSTRIES LTDAZELAIC ACID, MICRONIZED
29926AII10/19/2015FRED HUTCHINSON CANCER RESCTRB9E9SCFV4-SA FUSION PROTEIN
29747AII11/13/2015JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS GROUPBENZHYDROCODONE HCI
28840AII12/3/2015CEDARBURG PHARMACEUTICALSBENZTROPINE MESYLATE
30122AII12/9/2015BIZEN CHEMICAL CO LTDBIZEN EPA-70E (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE
30007AII11/4/2015BIZEN CHEMICAL CO LTDBIZEN EPA-E (ICOSAPENT ETHYL) DRUG SUBSTANCE
30025AII11/4/2015BIZEN CHEMICAL CO LTDBIZEN EPA-EC (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE
29867AII10/20/2015MSN LIFE SCIENCES PRIVATE LTDCANAGLIFLOZIN (AMORPHOUS) [ROUTE CODE "CU"]
29209AII11/19/2015TEVA PHARMACEUTICAL INDUSTRIES LTDCAPECITABINE
29492AII10/8/2015GE HEALTHCARECAPTO™ L, AFFINITY CHROMATOGRAPHY MEDIUM
29770AII9/28/2015QILU PHARMACEUTICAL CO LTDCARFILZOMIB (NON-STERILE, API)
29682AII11/12/2015SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTDCASPOFUNGIN ACETATE
30006AII12/23/2015CLEAVE BIOSCIENCESCB-5083 CAPSULES
30005AII12/23/2015CLEAVE BIOSCIENCES INCCB-5083 DRUG SUBSTANCE
29737AII10/6/2015CADILA HEALTHCARE LTDCINACALCET HYDROCHLORIDE
29866AII10/31/2015MSN ORGANICS PRIVATE LTDCINACALCET HYDROCHLORIDE [ROUTE CODE "CN"]
29738AII9/24/2015GLAND PHARMA LTDCISATRACURIUM BESYLATE [PROCESS-II]
29318AII9/10/2015SUN PHARMACEUTICAL INDUSTRIES LTDCLOFARABINE
29769AII9/26/2015QILU PHARMACEUTICAL CO LTDCLOFARABINE
29687AII11/3/2015TRIS PHARMA INCCOD-CPM-PSE ER ORAL SUSPENSION
29940AII10/21/2015SEQUENT SCIENTIFIC LTDCOLCHICINE
30001AII11/13/2015FORMOSA LABORATORIES INCCOLESEVELAM HYDROCHLORIDE
29955AII11/9/2015MACLEODS PHARMACEUTICALS LTDCYCLOBENZAPRINE HYDROCHLORIDE EXTENDED RELEASE PELLETS
29859AII9/17/2015LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDAPTOMYCIN
29760AII11/12/2015CHONGQING DAXIN PHARMACEUTICAL CO LTDDAPTOMYCIN, NON-STERILE, BULK DRUG
29784AII10/7/2015AMPAC FINE CHEMICALS LLCDEXMETHYLPHENIDATE HCl API
30087AII11/23/2015WEIFANG SHENGTAI MEDICINE CO LTDDEXTROSE ANHYDROUS
30079AII11/23/2015WEIFANG SHENGTAI MEDICINE CO LTDDEXTROSE MONOHYDRATE
30085AII12/28/2015RAKS PHARMA PVT LTDDIMETHYL FUMARATE
29632AII11/3/2015OPTIMUS DRUGS PRIVATE LTDDIMETHYL FUMARATE
29742AII9/29/2015ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDIMETHYL FUMARATE
30042AII12/17/2015INDUSTRIALE CHIMICA SRLDOFETILIDE USP
29722AII10/7/2015APICORE US LLCDOFETILIDE USP, POLYMORPH P162B
30011AII11/26/2015MYLAN LABORATORIES LTDDOLUTEGRAVIR SODIUM
30035AII11/16/2015OLON SPADOXORUBICIN HYDROCHLORIDE
29932AII3/25/2015SALVI CHEMICAL INDUSTRIES LTDDRIED FERROUS SULFATE USP
30094AII12/22/2015AMRI RENSSELAER INCDRONABINOL IN ETHANOL DRUG SUBSTANCE
29899AII10/26/2015MACLEODS PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE DELAYED-RELEASE PELLETS
30143AII12/23/2015STERLING CHEMICAL MALTA LTDDUTASTERIDE FORM I
29649AII9/15/2015NJOY INCELECTRONIC NICOTINE DELIVERY SYSTEM
29801AII10/23/2015BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDEMPAGLIFLOZIN
30010AII11/28/2015MYLAN LABORATORIES LTDENZALUTAMIDE
29679AII9/21/2015QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTDERLOTINIB HYDROCHLORIDE
27155AII11/10/2015ABBVIE INCERYTHROMYCIN BASE
30020AII12/10/2015MACLEODS PHARMACEUTICALS LTDESOMEPRAZOLE MAGNESIUM DELAYED - RELEASE PELLETS
29992AII11/4/2015ZHEJIANG JINHUA CONBA BIO PHARM CO LTDESOMEPRAZOLE MAGNESIUM DIHYDRATE
30076AII12/31/2015MSN LIFE SCIENCES PRIVATE LTDESOMEPRAZOLE MAGNESIUM USP (DIHYDRATE) [ROUTE CODE EP]
30075AII12/30/2015MSN LIFE SCIENCES PRIVATE LTDESOMPERAZOLE SODIUM [ROUTE CODE EU]
29951AII11/5/2015ALEMBIC PHARMACEUTICALS LTDETORICOXIB
29854AII10/19/2015SCINOPHARM TAIWAN LTDEVEROLIMUS
29863AII12/31/2015SUN PHARMACEUTICAL INDUSTRIES LTDEXENATIDE
29882AII10/5/2015HETERO LABS LTDEZETIMIBE (FORM-B)
28661AII11/23/2015ENALTEC LABS PRIVATE LTDFELBAMATE USP
29445AII10/29/2015PERRIGO API LTDFEXOFENADINE HYDROCHLORIDE
29374AII9/29/2015NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDFIDAXOMICIN
29975AII12/10/2015LUPIN LTDFLUTICASONE PROPIONATE USP
30137AII12/31/2015WOCKHARDT BIO AGFOSAPREPITANT DIMEGLUMINE
29887AII10/5/2015HANGZHOU JIUYUAN GENE ENGINEERING CO LTDFULVESTRANT
29629AII10/5/2015ESTECHPHARMA CO LTDGADODIAMIDE
29797AII11/17/2015SYNTHON BVGEFITINIB
29921AII10/8/2015TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDGLYBURIDE
30061AII11/30/2015SUVEN LIFE SCIENCES LTDGLYCOPYRROLATE USP
29990AII11/3/2015SIFAVITOR SRLGLYCOPYRRONIUM BROMIDE
29713AII9/10/2015ALP PHARM BEIJING CO LTDGOSERELIN ACETATE
29907AII11/13/2015HUYA BIOSCIENCE INTERNATIONALHBI-8000 DRUG SUBSTANCE
30008AII12/3/2015MALLINCKRODT INCHYDROCODONE BASE (NP)
30014AII11/24/2015FERMION OYHYDROXYCHLOROQUINE SULPHATE
29441AII9/30/2015FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN SODIUM
30117AII12/31/2015DR REDDYS LABORATORIES LTDINGENOL MEBUTATE
29843AII10/1/2015CIPLA LTDIPRATROPIUM BROMIDE USP
29876AII11/9/2015AMPHASTAR NANJING PHARMACEUTICALS INCISOPROTERENOL HYDROCHLORIDE USP
29717AII11/19/2015SAI LIFE SCIENCES LTDISOPROTERENOL HYDROCHLORIDE USP
30021AII12/14/2015MACLEODS PHARMACEUTICALS LTDLANSOPRAZOLE DELAYED - RELEASE PELLETS
29712AII9/10/2015ALP PHARM BEIJING CO LTDLAPATINIB DITOSYLATE
30043AII12/4/2015SCINOPHARM TAIWAN LTDLAPATINIB DITOSYLATE
29711AII9/10/2015ALP PHARM BEIJING CO LTDLIRAGLUTIDE
29302AII10/7/2015CHENGDU SHENGNUO BIOPHARM CO LTDLIRAGLUTIDE
30095AII12/7/2015HYBIO PHARMACEUTICAL CO LTDLIRAGLUTIDE NON-STERILE BULK DRUG SUBSTANCE
30015AII12/8/2015DR REDDYS LABORATORIES LTDLORCASERIN HYDROCHLORIDE HEMIHYDRATE
30118AII12/31/2015AUROBINDO PHARMA LTDLORCASERIN HYDROCHLORIDE HEMIHYDRATE
29977AII11/6/2015CENTAUR PHARMACEUTICALS PRIVATE LTDLOXAPINE SUCCINATE USP
29919AII10/30/2015GLENMARK PHARMACEUTICALS LTDLULICONAZOLE
30092AII12/29/2015ALEMBIC PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE
30003AII12/9/2015DAIICHI SANKYO CO LTDMAAA-1162A
30140AII12/23/2015TOMITA PHARMACEUTICAL CO LTDMAGALDRATE POWDER USP
29845AII9/22/2015TOMITA PHARMACEUTICAL CO LTDMAGNESIUM HYDROXIDE NK USP
29970AII11/30/2015MEDICHEM SAMED-201080/E
29674AII10/12/2015ARCH PHARMALABS LTDMEFENAMIC ACID USP ( PRODUCT CODE : 05P)
29855AII10/21/2015MACLEODS PHARMACEUTICALS LTDMEMANTINE HYDROCHLORIDE EXTENDED RELEASE PELLETS 28 MG
29998AII11/6/2015DIVIS LABORATORIES LTDMESALAMINE USP
30067AII12/1/2015VISTIN PHARMA ASMETFORMIN DC 92.6% LUBRICATED GRANULES
29954AII11/30/2015ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDMETOPROLOL SUCCINATE USP
30028AII11/11/2015BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDMICAFUNGIN SODIUM INTERMEDIATE A
29683AII10/19/2015ADARE PHARMACEUTICALS INCMICROCAPS® IBUPROFEN
29881AII10/5/2015SEQUENT SCIENTIFIC LTDMIDAZOLAM
29905AII11/23/2015EMCURE PHARMACEUTICALS LTDMILRINONE USP
29925AII12/31/2015LUPIN LTDMIRABEGRON
30030AII11/30/2015ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDMIRABEGRON
29317AII11/25/2015RHODES TECHNOLOGIES INCMORPHINE SULFATE, USP
29920AII10/8/2015JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTDMYCOPHENOLIC ACID
29619AII9/30/2015CHONGQING LAND TOWER PHARMACEUTICAL CO LTDNALTREXONE
29935AII12/7/2015ALKERMES INCNCD MELOXICAM BULK INTERMEDIATE
29730AII9/28/2015ZHEJIANG AUSUN PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE
30052AII12/3/2015SYNKEM SASNEBIVOLOL HYDROCHLORIDE
30136AII12/31/2015HARMAN FINOCHEM LTDNEOSTIGMINE METHYLSULFATE USP
29596AII10/23/2015BAYER PHARMA AGNIFEDIPINE DRUG SUBSTANCE
30088AII12/31/2015DR REDDYS LABORATORIES LTDNILOTINIB HYDROCHLORIDE
30098AII12/9/2015HETERO LABS LTDNILOTINIB HYDROCHLORIDE DIHYDRATE
29861AII10/29/2015NIPPON SHINYAKU CO LTDNS-065/NCNP-01
30131AII12/24/2015SCINOPHARM TAIWAN LTDOCTREOTIDE ACETATE
29865AII12/31/2015SUN PHARMACEUTICAL INDUSTRIES LTDOLOPATADINE HYDROCHLORIDE USP
29633AII10/21/2015GLENMARK PHARMACEUTICALS LTDOMEPRAZOLE USP
29914AII10/9/2015SHANDONG NEW TIME PHARMACEUTICAL CO LTDORLISTAT
30012AII11/30/2015MYLAN LABORATORIES LTDOSELTAMIVIR PHOSPHATE USP
30135AII12/24/2015GANGAGEN INCP 128
30102AII12/31/2015MYLAN LABORATORIES LTDPALIPERIDONE PALMITATE
30009AII11/27/2015MYLAN LABORATORIES LTDPEMETREXED DISODIUM HEMIPENTAHYDRATE
29897AII7/3/2015WANBURY LTDPHENAZOPYRIDINE HYDROCHLORIDE DC GRANULES
30090AII12/30/2015BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDPIMECROLIMUS (NON-STERILE, API)
29700AII11/4/2015HONOUR LAB LTDPIRFENIDONE
29650AII11/6/2015LUPIN LTDPITAVASTATIN SODIUM
29681AII10/30/2015SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTDPNEUMOCANDIN B0
29443AII11/13/2015AMCOL HEALTH AND BEAUTY SOLUTIONS INCPOLY-PORE® FLUOROURACIL POLYMER
29888AII10/21/2015SHANGHAI YUKING WATER SOLUBLE MATERIAL TECH CO LTDPOVIDONE-IODINE
29838AII9/21/2015SHANNXI JUNBISHA PHARMACEUTICAL CO LTDPOWDERED CENTELLA ASIATICA EXTRACT
29853AII12/24/2015RAKS PHARMA PVT LTDQUETIAPINE FUMARATE USP
29870AII11/3/2015MSN LABORATORIES PRIVATE LTDREGORAFENIB [ROUTE CODE "RZ"]
29922AII10/8/2015TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDREPAGLINIDE
29923AII10/8/2015TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDRIBOFLAVIN 5'-PHOSPHATE SODIUM
29841AII12/8/2015LAURUS LABS PRIVATE LTDRILPIVIRINE HYDROCHLORIDE
29858AII9/29/2015AARTI DRUGS LTDROFECOXIB
29190AII12/3/2015DELMAR CHEMICALS INCROSUVASTATIN CALCIUM
30133AII12/13/2015MELODY HEALTHCARE PVT LTDROSUVASTATIN CALCIUM
30054AII12/31/2015CIPLA LTDSAXAGLIPTIN HYDROCHLORIDE
30002AII11/13/2015FORMOSA LABORATORIES INCSEVELAMER CARBONATE
29659AII9/4/2015ALEMBIC PHARMACEUTICALS LTDSILODOSIN
29723AII9/30/2015CHEMWERTH INCSODIUM NITROPRUSSIDE
29871AII11/3/2015AMPHASTAR NANJING PHARMACEUTICALS INCSODIUM NITROPRUSSIDE USP
29989AII11/2/2015MACCO ORGANIQUES SROSODIUM SULFATE, USP
29531AII12/15/2015CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET-10275378]
29489AII11/2/2015CIPLA LTDSOLIFENACIN SUCCINATE
29941AII11/29/2015ALEMBIC PHARMACEUTICALS LTDSORAFENIB TOSYLATE
30139AII12/14/2015SAFC INCSULFO-SMCC
29765AII12/4/2015HONOUR LAB LTDTADALAFIL USP
30013AII12/24/2015MYLAN LABORATORIES LTDTENOFOVIR ALAFENAMIDE FUMARATE
29701AII10/1/2015HONOUR LAB LTDTERIFLUNOMIDE
29851AII10/21/2015RAKS PHARMA PVT LTDTERIFLUNOMIDE
29862AII12/30/2015FORMOSA LABORATORIES INCTERIFLUNOMIDE
29802AII9/29/2015MEGAFINE PHARMA P LTDTERIFLUNOMIDE DRUG SUBSTANCE
29869AII9/30/2015SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE USP (MICRONIZED)
29828AII10/9/2015ROLABO OUTSOURCING SLTETRABENAZINE
30000AII12/6/2015MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE [ROUTE CODE TB]
29915AII10/7/2015CHANGZHOU BOHIV PHARMACEUTICAL TECHNOLOGY CO LTDTREPROSTINIL INTERMEDIATE (PG14-15A)
29906AII12/7/2015MERCK KGAATRISODIUM CITRATE DIHYDRATE
29874AII10/6/2015MERCK KGAAUREA
30023AII11/12/2015CORDEN PHARMA COLORADO INCVALGANCICLOVIR HYDROCHLORIDE
29933AII10/14/2015HIKAL LTDVILDAGLIPTIN