DMF No.STATUSTYPESUBMIT DATEHOLDERSUBJECT
30571AII18-May-16WISCONSIN INSTITUTE FOR MEDICAL RESEARCH[18F] DCFPYL
30760AII26-Jul-16AVANTI POLAR LIPIDS INC1,2 -DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) (730355)
30919AII25-Aug-16NINGBO GREEN HEALTH PHARMACEUTICAL CO LTD10-DAB
30894AII24-Aug-16NOF CORP2,3-BIS(METHYLPOLYOXYETHYLENE-OXY)-1-{[3-(3-MALEIMIDO-1-OXOPROPYL)AMINO]PROPYLOXY} PROPANE (MW 60,000)
30568AII23-May-16LOBA FEINCHEMIE GMBH3,4-DIAMINOPYRIDINE
29744AII22-Aug-16JOHNSON MATTHEY PHARMA SERVICES4250.C
29782AII01-Jun-16JOHNSON MATTHEY PHARMA SERVICES4302.E
30911AII23-Aug-16HEBEI WORLDSTAR CHEMICAL CO LTD4AA (4-ACETOXYAZETIDIN-2-ONE)
30522AII07-Mar-16JENKEM TECHNOLOGY CO LTD4ARM PEG SUCCINIMIDYL SUCCINATE (PENTAERYTHRITOL) MW 10000
30610AII26-May-16SUNBIO INC4-ARM POLYETHYLENE GLYCOL AMINE 10,000
30779AII02-Aug-16SINOPHARM WEIQIDA DATONG PHARMACEUTICAL CO LTD6-AMINOPENICILLANIC ACID
30473AII09-May-16SINOPHARM WEIQIDA PHARMACEUTICAL CO LTD7-AMINOCEPHALOSPORANIC ACID
30601AII11-Jul-16AURISCO PHARMACEUTICAL LTD9-(2-PHOSPHONYLMETHOXYPROPYL) ADENINE (PMPA)
30587AII01-Jun-16SCINOPHARM TAIWAN LTDABIRATERONE ACETATE
30734AII09-Sep-16PIRAMAL HEALTHCARE CANADA LTDAGB DRUG SUBSTANCE
30967A II09-Nov-16CIPLA LTDALBENDAZOLE (B) USP
30708AII27-Jun-16SUPRIYA LIFESCIENCE LTDALBUTEROL SULFATE USP
30577AII18-Jul-16HONOUR LAB LTDALOGLIPTIN BENZOATE
30612AII30-Jun-16INDOCO REMEDIES LTDALOGLIPTIN BENZOATE
30913AII30-Sep-16HEC PHARM CO LTDALOGLIPTIN BENZOATE NON-STERILE BULK DRUG SUBSTANCE
30563AII31-May-16MSN LIFE SCIENCES PRIVATE LTDALVIMOPAN DIHYDRATE
30553AII24-May-16WATSON PHARMA PRIVATE LTDALVIMOPAN DIHYDRATE
30799AII19-Jul-16JIANGSU JOYGLORY PHARMACEUTICAL CO LTDAMBRISENTAN
30717AII16-Jul-16HETERO DRUGS LTDAMLODIPINE BESYLATE(PROCESS-II)
30725AII06-Jul-16ANTIBIOTICOS DE LEON SLUAMOXICILLIN TRIHYDRATE
30815AII02-Aug-16ANTIBIOTICOS DE LEON SLUAMPICILLIN TRIHYDRATE
30452AII01-Apr-16JSR LIFE SCIENCES CORPAMSPHERE TM A3
30440AII01-Apr-16SCINOPHARM TAIWAN LTDAPIXABAN
30461AII18-May-16HONOUR LAB LTDAPIXABAN
30479AII22-Jun-16TEVA PHARMACEUTICAL INDUSTRIES LTDAPIXABAN
30499AII20-Jun-16APOTEX PHARMACHEM INDIA PVT LTDAPIXABAN
30613AII20-Jul-16INDOCO REMEDIES LTDAPIXABAN
30619AII12-Aug-16MICRO LABS LTDAPIXABAN
30630AII06-Jul-16CADILA HEALTHCARE LTDAPIXABAN
30635AII29-Jul-16WATSON PHARMA PRIVATE LTDAPIXABAN
30646AII30-Jun-16MEDICHEM MANUFACTURING MALTA LTDAPIXABAN
30653AII28-Jun-16SINTENOVO SA DE CVAPIXABAN
30704AII12-Jul-16AUROBINDO PHARMA LTDAPIXABAN
30845AII30-Sep-16NATCO PHARMA LTDAPIXABAN
30929AII16-Sep-16UNICHEM LABORATORIES LTDAPIXABAN
30788AII23-Sep-16SUN PHARMACEUTICAL INDUSTRIES LTDAPIXABAN
30774AII10-Aug-16SIGMAPHARM LABORATORIES LLCAPIXABAN AMORPHOUS (6.58%)
30874AII31-Aug-16HEC PHARM CO LTDAPIXABAN NON-STERILE BULK DRUG SUBSTANCE
30248AII06-Apr-16LUPIN LTDAPREMILAST
30732AII30-Sep-16DR REDDYS LABORATORIES LTDAPREMILAST (FORM B)
30866AII31-Aug-16MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (FORM-M)
30674AII22-Sep-16ADARE PHARMACEUTICALS INCAPT-5032 EXTENDED RELEASE CAPSULES
30591AII23-Aug-16ADARE PHARMACEUTICALS INCAR18 - APT5033 EXTENDED RELEASE ORALLY DISINTEGRATING TABLETS
30954AII28-Sep-16HEC PHARM CO LTDARIPIPRAZOLE NON-STERILE BULK DRUG SUBSTANCE
30350AII20-Apr-16TEVA PHARMACEUTICAL INDUSTRIES LTDARMODAFINIL 7SM1029
30618AII05-Jul-16DSM NUTRITIONAL PRODUCTS LTDASCORBIC ACID
30934AII29-Sep-16LAURUS LABS PRIVATE LTDATAZANAVIR SULFATE
30754AII01-Sep-16MACLEODS PHARMACEUTICALS LTDATOMOXETINE HYDROCHLORIDE
30605AII09-Sep-16CENTROFLORA CMS SARLATROPINE SULFATE USP
29864AII30-Sep-16SUN PHARMACEUTICAL INDUSTRIES LTDAZACITIDINE
29775AII20-May-16JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS GROUPB1450
30195AII27-Jun-16QUIMICA SINTETICA SABENZNIDAZOLE
30716AII01-Aug-16GLAND PHARMA LTDBETAMETHASONE ACETATE USP STERILE
30576AII03-Jun-16HETERO LABS LTDBORTEZOMIB (FORM-II)
30552AII30-Jun-16ALEMBIC PHARMACEUTICALS LTDBOSUTINIB
30683AII08-Jul-16MSN LABORATORIES PRIVATE LTDBOSUTINIB MONOHYDRATE (FORM-I)
30762AII04-Aug-16RHODES TECHNOLOGIESBUPRENORPHINE
29885AII16-Aug-16RHODES TECHNOLOGIES INCBUPRENORPHINE HYDROCHLORIDE, USP
30615AII28-Jun-16CERBIOS PHARMA SACALCIPOTRIENE MONOHYDRATE
30449AII15-Apr-16LUPIN LTDCANAGLIFLOZIN
30753AII09-Sep-16MACLEODS PHARMACEUTICALS LTDCANAGLIFLOZIN
30771AII30-Aug-16MYLAN LABORATORIES LTDCANAGLIFLOZIN
30879AII20-Sep-16ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCANAGLIFLOZIN
30941AII16-Sep-16ALKEM LABORATORIES LTDCANAGLIFLOZIN
30951A II21-Oct-16INDOCO REMEDIES LTDCANAGLIFLOZIN
30964AII28-Sep-16AUROBINDO PHARMA LTDCANAGLIFLOZIN
31025AII30-Sep-16DR REDDYS LABORATORIES LTDCANAGLIFLOZIN
30853AII19-Aug-16CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDCANAGLIFLOZIN MONOHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)
30658AII27-Sep-16NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCHCANNABIDIOL
30638AII30-Jun-16AMRI RENSSELAER INCCANNABIDIOL DRUG SUBSTANCE
30543AII23-Jun-16SIGNA SA DE CVCAPECITABINE USP
30706AII07-Jul-16CHILLIES EXPORT HOUSE LTDCAPSAICIN USP
30566AII20-Sep-16MACLEODS PHARMACEUTICALS LTDCARVEDILOL PHOSPHATE
30551AII24-May-16AMOLI ORGANICS PVT LTDCHLORTHALIDONE USP
30862AII12-Sep-16ESJAY PHARMA LLCCHLORZOXAZONE USP
30832AII20-Sep-16DSM NUTRITIONAL PRODUCTS LTDCHOLECALCIFEROL (VITAMIN D3)
30470AII12-Apr-16VERTELLUS HEALTH AND SPECIALTY PRODUCTS LLC CHROMIUM (III) PICOLINATE
31033AII19-Sep-16ZHEJIANG FENG'AN BIO-PHARMACEUTICAL CO LTDCHYMOTRYPSIN
30616AII27-Jun-16UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)CIPROFLOXACIN HYDROCHLORIDE USP
29850AII10-Aug-16ALP PHARM BEIJING CO LTDCLEVIDIPINE BUTYRATE
30540AII30-May-16RAKS PHARMA PVT LTDCLOBAZAM
30875AII02-Sep-16MSN LIFE SCIENCES PRIVATE LTDCLOBAZAM
30752AII01-Jul-16ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP
30814AII20-Aug-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOMIPRAMINE HYDROCHLORIDE
30287AII07-Sep-16HONOUR LAB LTDCOBICISTAT ON COLLOIDAL SILICON DIOXIDE
30650AII02-Jul-16MSN LIFE SCIENCES PRIVATE LTDCOBICISTAT ON SILICON DIOXIDE
30824AII11-Jul-16CALTRON CLAYS AND CHEMICALS PVT LTDCORAL CALCIUM CARBONATE
30598AII03-Aug-16MACLEODS PHARMACEUTICALS LTDCYCLOSERINE
30460AII05-Apr-16STRIDES SHASUN LTDDABIGATRAN ETEXILATE MESYLATE
30737AII11-Aug-16CIPLA LTDDACLATASVIR DIHYDROCHLORIDE
30975A II07-Oct-16HETERO LABS LTDDACLATASVIR DIHYDROCHLORIDE
30555AII12-May-16ZAKLADY FARMACEUTYCZNE POLPHARMA SADAPAGLIFLOZIN
30592AII26-May-16CHENGDU YACHT BIOTECHNOLOGY CO LTDDAPTOMYCIN
30803A II05-Oct-16RAKS PHARMA PVT LTDDARUNAVIR
30882A II06-Oct-16MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR (AMORPHOUS)
30596AII27-Jun-16MYLAN LABORATORIES LTDDARUNAVIR (PROCESS-II)
30589AII06-Jun-16MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR ETHANOLATE
30735AII29-Jul-16MYLAN LABORATORIES LTDDARUNAVIR ETHANOLATE
31011A II12-Oct-16HETERO LABS LTDDARUNAVIR ETHANOLATE (PROCESS-II)
30286AII04-Apr-16CIPLA LTDDARUNAVIR HYDRATE(PROCESS II)
30695AII29-Jun-16MEDILUX LABORATORIES PVT LTDDEFERASIROX
30817AII20-Sep-16CIPLA LTDDEFERASIROX
30084AII13-May-16RAKS PHARMA PVT LTDDEXLANSOPRAZOLE (ROUTE CODE - DR)
30657A II11-Oct-16MALLINCKRODT INCDEXMETHYLPHENIDATE HYDROCHLORIDE
30723AII02-Sep-16DSM NUTRITIONAL PRODUCTS LTDDEXPANTHENOL
30515AII21-Apr-16HENAN DONGTAI PHARM CO LTDDICLOFENAC POTASSIUM
30724AII06-Jul-16ALCHEM INTERNATIONAL PRIVATE LTDDIGOXIN USP
30497AII15-Apr-16OLON SPADIHYDROERGOTAMINE MESYLATE
30950AII29-Aug-16RIOCARE INDIA PRIVATE LTDDIMETHICONE USP
29913AII31-Aug-16TEVA PHARMACEUTICAL INDUSTRIES LTDDIMETHYL FUMARATE
30283AII31-Mar-16MACLEODS PHARMACEUTICALS LTDDIMETHYL FUMARATE
30622AII26-Jul-16ALKEM LABORATORIES LTDDIMETHYL FUMARATE
30629AII06-Jul-16CADILA HEALTHCARE LTDDIMETHYL FUMARATE
30823AII26-Sep-16TORRENT PHARMACEUTICALS LTDDIMETHYL FUMARATE
30863AII30-Sep-16MICRO LABS LTDDIMETHYL FUMARATE
30928AII15-Sep-16AUROBINDO PHARMA LTDDIMETHYL FUMARATE
30936AII29-Sep-16TEVA PHARMACEUTICAL INDUSTRIES LTDDIMETHYL FUMARATE
30938AII27-Sep-16GRANULES INDIA LTDDIMETHYL FUMARATE
31004A II04-Oct-16NATCO PHARMA LTDDIMETHYL FUMARATE
30944AII20-Sep-16ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDIMETHYL FUMARATE (PROCESS II)
30673AII21-Jul-16DSM NUTRITIONAL PRODUCTS LTDDL-ALPHA-TOCOPHERYL ACETATE
30508AII29-Jun-16BIDDLE SAWYER PHARMA LLCDOFETILIDE USP
30560AII01-Jun-16AUROBINDO PHARMA LTDDOFETILIDE USP
30544AII20-May-16HETERO LABS LTDDOLUTEGRAVIR SODIUM
30935AII28-Sep-16LAURUS LABS PRIVATE LTDDOLUTEGRAVIR SODIUM
30539AII10-Aug-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDDOTA
30833AII28-Sep-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDD-PENICILLAMINE
30492AII06-Sep-16NAVINTA LLCDS121 DRUG SUBTANCE
30959A II21-Oct-16ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDEFAVIRENZ USP
30538AII31-May-16PERRIGO API LTDEFINACONAZOLE
30892AII30-Sep-16GLENMARK PHARMACEUTICALS LTDEFINACONAZOLE
30772AII30-Aug-16MSN LIFE SCIENCES PRIVATE LTDELVITEGRAVIR (FORM-II)
30446AII02-Apr-16WISDOM PHARMACEUTICAL CO LTDENTECAVIR INTERMEDIATE
29872AII24-May-16WATSON PHARMA PRIVATE LTDENZALUTAMIDE
30644AII09-Jul-16SCINOPHARM TAIWAN LTDENZALUTAMIDE
30885AII29-Aug-16INTAS PHARMACEUTICALS LTDERLOTINIB HYDROCHLORIDE
30709AII19-May-16QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTDERTAPENEM SODIUM (NON-STERILE)
30407AII11-Mar-16ESCO-EUROPEAN SALT CO GMBH AND CO KGESCO API NACI SODIUM CHLORIDE GMP GRADE
30485III15-Apr-16TIANJIN WEIJIE PHARMACEUTICAL CO LTDESLICARBAZEPINE ACETATE
30901AII15-Sep-16ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD
ESOMEPRAZOLE MAGNESIUM
30175AII31-May-16SUN PHARMACEUTICAL INDUSTRIES LTDESOMEPRAZOLE MAGNESIUM USP(AMORPHOUS)
30036AII15-Apr-16UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)ESOMEPRAZOLE MAGNESIUM DIHYDRATE
30787AII17-Aug-16ALKEM LABORATORIES LTDESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
30667AII20-Jul-16UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)ESOMEPRAZOLE SODIUM
30813AII19-Sep-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDETHACRYNATE SODIUM
30188AII01-Jun-16KEWPIE CORPETHYL ICOSAPENTATE DRUG SUBSTANCE
30884AII01-Sep-16EVOLV LLCEVOLV E-LIQUID
30924AII28-Sep-16LONZA AGEXENATIDE USP
30801AII17-Aug-16AUROBINDO PHARMA LTDEZETIMIBE USP
30378AII14-Apr-16LUPIN LTDEZETIMIBE USP (PROCESS-C)
29702AII09-May-16GE HEALTHCAREFASTLAB FDG DUO CASSETTE
30347AII13-Apr-16LUPIN LTDFERRIC CITRATE
30835AII28-Sep-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDFERRIC CITRATE
30692AII27-Jun-16MOREPEN LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE USP
30604AII16-Aug-16GRANULES INDIA LTDFEXOFENADINE HYDROCHLORIDE, USP
30417AII26-Sep-16CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)
30651AII05-Jul-16DSM NUTRITIONAL PRODUCTS LTDFOLIC ACID
30767AII15-Jul-16BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDFONDAPARINUX SODIUM (NON-STERILE, API)
30324AII04-Jun-16CORAL DRUGS PRIVATE LTDFORMOTEROL FUMARATE DIHYDRATE
30713AII29-Jul-16TREIBACHER INDUSTRIE AGGADOLINIUM OXIDE
30800AII28-Jul-16HYBIO PHARMACEUTICAL CO LTDGANIRELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
30518AII28-Apr-16ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDGEFITINIB
30868AII19-Sep-16ALEMBIC PHARMACEUTICALS LTDGEFITINIB
30693AII28-Jun-16LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDGENTAMICIN SULFATE
30685AII20-Jun-16ZHEJIANG ZHOUSHAN PUTUO XINXING PHARMAS CO LTDGLUCOSAMINE HYDROCHLORIDE USP
30550AII03-May-16TAIHUA NATURAL PLANT PHARMACEUTICAL CO LTDHOMOHARRINGTONINE
30316AII22-Apr-16KEWPIE CORPHYALURONSAN HA-AML(SODIUM HYALURONATE) DRUG SUBSTANCE
30354AII07-Apr-16MACLEODS PHARMACEUTICALS LTDHYDRALAZINE HYDROCHLORIDE
30373AII03-Mar-16SANOFI CHIMIEHYDROCORTISONE
30820AII05-Aug-16SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE ACETATE USP
30971AII12-Sep-16YANGZHOU PHARMACEUTICAL CO LTDHYDROCORTISONE VALERATE USP
30825AII01-Aug-16CHONGQING KANGLE PHARMACEUTICAL CO LTDHYDROXYCHLOROQUINE SULFATE USP
30747AII19-Jul-16SYMBIOTEC PHARMALAB PRIVATE LTDHYDROXYPROGESTERONE CAPROATE USP
30897AII29-Aug-16ROQUETTE FRERESHYDROXYPROPYL BETADEX
30687AII06-Jul-16ALCHEM INTERNATIONAL PRIVATE LTDHYOSCINE EP (SCOPOLAMINE)
30746AII16-Aug-16PERRIGO API LTDIBRUTINIB
30557AII31-May-16MSN LABORATORIES PRIVATE LTDIBRUTINIB (AMORPHOUS)
30759AII31-Jul-16MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-A)
30476AII09-Jun-16TEVA PHARMACEUTICAL INDUSTRIES LTDICATIBANT ACETATE
30526AII27-Sep-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDICATIBANT ACETATE
30672AII25-Jul-16MSN LIFE SCIENCES PRIVATE LTDICATIBANT ACETATE
30998AII21-Sep-16JIANGSU WILLILNG BIO-TEC CO LTD IMIDACLOPRID NON STERILE BULK DRUG SUBSTANCE
30871AII30-Sep-16CADILA HEALTHCARE LTDIMATINIB MESYLATE
28192AII28-Jun-16SIGNA SA DE CVIMATINIB MESYLATE
30960AII21-Sep-16HETERO LABS LTDIMATINIB MESYLATE (FORM-B)
30844AII02-Aug-16LIFE TECHNOLOGIES LTDINCHINNAN AGT MEDIA
30493AII09-Jun-16PIRAMAL HEALTHCARE CANADA LTDIPLLJ8 DRUG SUBSTANCE
30261AII05-Aug-16SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE
30516AII12-Apr-16AVRA LABORATORIES PRIVATE LTDIRINOTECAN HYDROCHLORIDE USP
28865AII07-Jul-16DR REDDYS LABORATORIES LTDIRON SUCROSE
30652AII15-Sep-16CHEMWERTH INCISOPROTERENOL HCL USP
30811AII13-Aug-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOPROTERENOL HYDROCHLORIDE
30707AII23-Jul-16HARMAN FINOCHEM LTDISOPROTERENOL HYDROCHLORIDE USP
30564AII07-Jun-16NEULAND LABORATORIES LTDLABETALOL HYDROCHLORIDE USP
30889AII22-Aug-16NEWGEN BIOTECH (NINGBO)LACTASE USP
29693AII16-Aug-16SINOPEP JIANGSU INCLANREOTIDE ACETATE
29628AII16-Sep-16CIPLA LTDLENALIDOMIDE
30626AII27-Jun-16HETERO LABS LTDLEVETIRACETAM (FORM-1), PROCESS-II
30495AII07-Jun-16CERBIOS PHARMA SALEVOFOLINIC ACID CRYSTALLINE
30891AII21-Sep-16MSN LIFE SCIENCES PRIVATE LTDLEVOMILNACIPRAN HYDROCHLORIDE
30486AII01-Jun-16MACLEODS PHARMACEUTICALS LTDLINEZOLID
30942AII30-Sep-16AZICO BIOPHORE INDIA PVT LTDLIOTHYRONINE SODIUM
30467AII29-Jun-16BACHEM AMERICAS INCLIRAGLUTIDE DRUG SUBSTANCE
30201AII28-Apr-16ADARE PHARMACEUTICALS INCLOPERAMIDE MICROCAPS?
30636AII30-Jul-16HETERO LABS LTDLOPINAVIR (PROCESS-II)
30802AII08-Aug-16ZHEJIANG AUSUN PHARMACEUTICAL CO LTDLUBIPROSTONE
29794AII07-May-16NEULAND LABORATORIES LTDLURASIDONE HYDROCHLORIDE
30464AII05-Apr-16STRIDES SHASUN LTDLURASIDONE HYDROCHLORIDE
31023AII26-Sep-16ADVANCED ACCELERATOR APPLICATIONS USA INCLYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTION
30969AII30-Sep-16MYLAN LABORATORIES LTDMACITENTAN
30512AII07-Apr-16JOST CHEMICAL COMANGANESE SULFATE MONOHYDRATE
30912AII23-Aug-16HEBEI WORLDSTAR CHEMICAL CO LTDMAP (BETA-METHYL VINYL PHOSPHATE)
30325AII28-Mar-16SHAANXI HANJIANG PHARMACEUTICAL GROUP CO LTDMEBENDAZOLE POLYMORPH C
30548AII05-Sep-16SIGMA-ALDRICH PRODUCTION GMBHMEBROFENIN
30489AII10-Jun-16ACS DOBFAR SPAMEROPENEM TRIHYDRATE NON STERILE
30488AII21-Jul-16ACS DOBFAR SPAMEROPENEM TRIHYDRATE STERILE
30114AII04-May-16LAURUS LABS PRIVATE LTDMETFORMIN HYDROCHLORIDE USP
30962AII10-Sep-16VITAL LABORATORIES PVT LTDMETHSCOPOLAMINE BROMIDE
30116AII14-Apr-16AMPAC FINE CHEMICALS LLCMETHYLPHENIDATE HCI
30579AII19-May-16MACFARLAN SMITH LTDMETHYLPHENIDATE HYDROCHLORIDE
29411AII27-May-16NORAMCO INCMETHYLPHENIDATE HYDROCHLORIDE
30510AII25-May-16JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)
30682AII29-Jul-16ALKEM LABORATORIES LTDMETHYLPHENIDATE HYDROCHLORIDE USP
30789AII27-Jul-16HIKMA PHARMACEUTICALS PLCMETHYLPREDNISOLONE ACETATE USP (STERILE)
30375AII15-Apr-16LUPIN LTDMETHYLPREDNISOLONE SODIUM SUCCINATE
30558AII06-Jun-16MEDICHEM MANUFACTURING MALTA LTDMICAFUNGIN SODIUM
30880AII30-Sep-16BIOCON LIMITEDMICAFUNGIN SODIUM
30988AII09-Aug-16YUNG ZIP CHEMICAL IND CO LTDMICONAZOLE BASE
30806AII27-Sep-16ENALTEC LABS PRIVATE LTDMIDODRINE HYDROCHLORIDE USP
30413AII02-Jun-16DR REDDYS LABORATORIES LTDMIRABEGRON PREMIX
30850AII07-Sep-16NEULAND LABORATORIES LTDMIRTAZAPINE USP (ACETONE ROUTE)
30239AII04-May-16MERCK SHARP AND DOHME CORPMK-6240
30852AII09-Sep-16CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE
30521AII25-Apr-16NENTER AND CO INCMONTELUKAST SODIUM INTERMEDIATE MK5
30848AII18-Aug-16ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE
30575AII25-May-16SYNBIAS PHARMA LTDNELARABINE
30593AII21-Jun-16MYLAN LABORATORIES LTDNEPAFENAC
30594AII30-Jun-16MYLAN LABORATORIES LTDNEPAFENAC (STERILE)
29606AII14-Jul-16ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE HEMIHYDRATE USP
30711AII13-Jun-16LONZA AGNIACINAMIDE FOR ORAL USE
30755AII17-Aug-16MACLEODS PHARMACEUTICALS LTDNITROFURANTOIN ANHYDROUS (MACROCRYSTAL)
30285AII19-May-16MACLEODS PHARMACEUTICALS LTDNITROFURANTOIN MONOHYDRATE
30315AII15-Apr-16PIRAMAL HEALTHCARE UK LTDNORPROSTOL
30984AII21-Sep-16BIOLOGICAL INDUSTRIES ISRAEL BEIT-HAEMEK LTDNUTRISTEM? HPSC XF
30992A II03-Nov-16ALP PHARM BEIJING CO LTDOCTREOTIDE ACETATE
30249AII20-Sep-16CHENGDU SHENGNUO BIOPHARM CO LTDOCTREOTIDE ACETATE USP
30463AII31-Aug-16AMRI RENSSELAER INCOMACETAXINE MEPESUCCINATE
30103AII09-May-16CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDOMEGA-3-CARBOXYLIC ACIDS
30529AII23-May-16OTSUKA PHARMACEUTICAL CO LTDOPA-15406 DRUG SUBSTANCE
30780AII01-Aug-16MURLI KRISHNA PHARMA PVT LTDORLISTAT PELLETS 50.0% W/W
30253AII13-Apr-16LUPIN LTDOSELTAMIVIR PHOSPHATE USP
30474AII13-Jun-16TIANJIN WEIJIE PHARMACEUTICAL CO LTDOSPEMIFENE
30574AII30-Jun-16GLENMARK PHARMACEUTICALS LTDOSPEMIFENE
30858A II18-Oct-16HONOUR LAB LTDOSPEMIFENE
30537AII21-Jun-16TEVA PHARMACEUTICAL INDUSTRIES LTDPACLITAXEL SEMISYNTHETIC (9-DHB)
30454AII20-Apr-16TEVA PHARMACEUTICAL INDUSTRIES LTDPACLITAXEL SEMISYNTHETIC (FROM 10-DAB)
30722AII03-Aug-16CIPLA LTDPALIPERIDONE
30597AII28-Jun-16MYLAN LABORATORIES LTDPALIPERIDONE PALMITATE (STERILE)
29328AII07-Apr-16INTERQUIM SAPALIPERIDONE PALMITATE STERILE
30955A II20-Oct-16WOCKHARDT BIO AGPALONOSETRON HYDROCHLORIDE USP
30573AII14-May-16WANBURY LTDPAROXETINE MESYLATE
30758AII30-Jul-16ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDPENCICLOVIR (API)
30993A II19-Oct-16APICORE US LLCPENICILLAMINE, USP
30214AII20-Apr-16FIS FABBRICA ITALIANA SINTETICI SPAPENTAZOCINE
30475AII21-Apr-16TEVA PHARMACEUTICAL INDUSTRIES LTDPERAMPANEL
30527AII02-Jun-16CADILA HEALTHCARE LTDPERAMPANEL
30649AII24-Jun-16INTAS PHARMACEUTICALS LTDPERAMPANEL
30391AII30-Jun-16TARO PHARMACEUTICAL INDUSTRIES LTDPERAMPANEL 3/4 HYDRATE, MICRONIZED
30810AII30-Aug-16APOTEX PHARMACHEM INDIA PVT LTDPERINDOPRIL ARGININE
30756AII30-Sep-16MACLEODS PHARMACEUTICALS LTDPERPHENAZINE
30176AII24-Sep-16ENALTEC LABS PRIVATE LTDPHYTONADIONE USP
30775AII17-Sep-16EMCURE PHARMACEUTICALS LTDPHYTONADIONE USP
30910AII20-Sep-16NAVINTA LLCPHYTONADIONE USP (PROCESS A)
30351AII13-Apr-16LUPIN LTDPIRFENIDONE
30922AII30-Sep-16GRANULES INDIA LTDPIRFENIDONE
30952AII20-Sep-16SHILPA MEDICARE LTDPIRFENIDONE
30877AII06-Sep-16MSN LABORATORIES PRIVATE LTDPLERIXAFOR
30761AII24-Aug-16SASOL GERMANY GMBHPOLYETHYLENE GLYCOL (LIPOXOL MED SP)
30549AII10-May-16OLON SPAPOMALIDOMIDE
30668AII14-Jul-16HETERO LABS LTDPOMALIDOMIDE
30696AII02-Aug-16SYNTHON BVPOMALIDOMIDE
30953A II21-Oct-16APICORE US LLCPOMALIDOMIDE
30343AII31-Mar-16APOTEX PHARMACHEM INCPOSACONAZOLE
30886AII30-Sep-16BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE III
30513AII07-Apr-16JOST CHEMICAL COPOTASSIUM PHOSPHATE DIBASIC
30514AII07-Apr-16JOST CHEMICAL COPOTASSIUM PHOSPHATE MONOBASIC
30565AII17-Sep-16MACLEODS PHARMACEUTICALS LTDPRASUGREL HYDROCHLORIDE
30764AII14-Jul-16ZAKLADY FARMACEUTYCZNE POLPHARMA SAPRASUGREL HYDROCHLORIDE
30765AII14-Jul-16ZAKLADY FARMACEUTYCZNE POLPHARMA SAPRASUGREL MALEATE
30625AII03-Jun-16HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE USP (PROCESS I)
30273AII27-May-16GLENMARK PHARMACEUTICALS LTDPREGABALIN
30517AII25-Apr-16WANBURY LTDPREGABALIN
30663AII28-Jun-16DR REDDYS LABORATORIES LTDPREGABALIN
30790AII01-Aug-16DIVI'S LABOTATORIES LTDPREGABALIN (ALTERNATIVE PROCESS)
30793AII30-Jul-16JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTDPROGESTERONE
30429AII16-Sep-16AMPHASTAR NANJING PHARMACEUTICALS INC (ANP) AN AMPHASTAR COPROTAMINE SULFATE USP
30448AII25-May-16MACLEODS PHARMACEUTICALS LTDPYRAZINAMIDE
30627AII01-Jul-16HETERO LABS LTDQUETIAPINE FUMARATE
30595AII24-Jun-16MYLAN LABORATORIES LTDRALTEGRAVIR
30712AII31-Aug-16APOTEX PHARMACHEM INDIA PVT LTDRANOLAZINE
30600AII21-Jun-16TORRENT PHARMACEUTICALS LTDRASAGILINE MESYLATE
30268AII14-Feb-16AKRON BIOTECHNOLOGY LLCRECOMBINANT HUMAN INTERLEUKIN-2
30542AII10-May-16EUTICALS INCREGADENOSON
30834AII13-Sep-16BIOPHORE INDIA PHARMACEUTICALS PVT LTDREGADENOSON
30490AII13-May-16HETERO LABS LTDREGORAFENIB
30156AII27-Sep-16NAVINTA LLCREMIFENTANIL HYDROCHLORIDE
30831AII07-Sep-16DSM NUTRITIONAL PRODUCTS LTDRIBOFLAVIN 5-PHOSPHATE SODIUM
30609AII28-Sep-16NEULAND LABORATORIES LTDRIVAROXABAN
30562AII08-Jun-16INTAS PHARMACEUTICALS LTDRIVAROXABAN FORM- I (MICRONIZED)
30152AII23-Sep-16NAVINTA LLCROPIVACAINE HYDROCHLORIDE USP
30890A II11-Oct-16ABBVIE STEMCENTRX LLCSC-LD003
30721AII06-Jul-16ALCHEM INTERNATIONAL PRIVATE LTDSCOPOLAMINE HYDROBROMIDE USP
30569AII18-Jun-16HETERO DRUGS LTDSEVELAMER CARBONATE
30570AII28-Sep-16JIANGSU HENGRUI MEDICINE CO LTDSEVOFLURANE USP
29777AII31-May-16JOHNSON MATTHEY PHARMA SERVICESSILODOSIN
30949AII29-Aug-16RIOCARE INDIA PRIVATE LTDSIMETHICONE EMULSION USP
30430AII05-May-16BASILDON CHEMICAL CO LTDSIMETHICONE EMULSION USP (BC SIMETHICONE ANTIFOAM PD30S)
30948AII29-Aug-16RIOCARE INDIA PRIVATE LTDSIMETHICONE USP
30349AII23-Mar-16BASILDON CHEMICAL CO LTDSIMETHICONE USP (BASILDON CHEMICALS SIMETHICONE AFC2-2671)
30836AII18-Jul-16STERLING BIOTECH LTDSIMVASTATIN AMMONIUM SALT DRUG SUBSTANCE INTERMEDIATE
30837AII20-Jul-16STERLING BIOTECH LTDSIMVASTATIN USP
30857AII22-Sep-16HONOUR LAB LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE
30974A II12-Oct-16HARMAN FINOCHEM LTDSITAGLIPTIN PHOSPHATE USP
30736AII20-Jul-16GALACTIC SASODIUM (S)-LACTATE SOLUTION
30487AII09-Aug-16ACS DOBFAR SPASODIUM CARBONATE STERILE LYOPHILIZED
30849AII13-Sep-16APICORE US LLCSODIUM NITROPRUSSIDE USP
30410AII19-May-16CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET 10275375-7]
30455AII21-Jun-16CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET- 10275405-7]
30930A II21-Oct-16CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET-10258867]
30628AII24-Jun-16CATALENT PHARMA SOLUTIONS LLCSOFTGELS [OET-10259014]
30541AII02-Jun-16RAKS PHARMA PVT LTDSOLIFENACIN SUCCINATE
30671AII21-Jul-16DELMAR CHEMICALS INCSOLIFENACIN SUCCINATE
30768AII25-Jul-16ROVI CONTRACT MANUFACTURING SLSTERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGE
30348AII15-Apr-16LUPIN LTDSUCROFERRIC OXYHYDROXIDE
30559AII03-Jun-16MEDICHEM MANUFACTURING MALTA LTDSUNITINIB MALATE
30860AII05-Sep-16QILU TIANHE PHARMACEUTICAL CO LTDTADALAFIL
30608AII10-Jun-16AMOLI ORGANICS PVT LTDTADALAFIL USP
30450AII12-Apr-16MACLEODS PHARMACEUTICALS LTDTAMSULOSIN HYDROCHLORIDE MODIFIED RELEASE PELLETS 0.4 MG/ 275MG
30583AII12-Aug-16AMBIOPHARM INCTEDUGLUTIDE NON-STERILE
30991A II09-Nov-16CIPLA LTDTENOFOVIR ALAFENAMIDE FUMARATE
30730AII25-Jul-16AURISCO PHARMACEUTICAL LTDTENOFOVIR DISOPROXIL FUMARATE
30435AII15-Apr-16TIANJIN WEIJIE PHARMACEUTICAL CO LTDTERBINAFINE HYDROCHLORIDE
30426AII01-Apr-16CADILA HEALTHCARE LTDTERIFLUNOMIDE
30491AII21-Apr-16INTAS PHARMACEUTICALS LTDTERIFLUNOMIDE
30506AII29-Apr-16NATCO PHARMA LTDTERIFLUNOMIDE
30741AII11-Jul-16ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE
30377AII11-Apr-16LUPIN LTDTESTOSTERONE USP
30634AII29-Jun-16DSM NUTRITIONAL PRODUCTS LTDTHIAMINE HYDROCHLORIDE
30531AII04-Jun-16CADILA HEALTHCARE LTDTOFACITINIB CITRATE
30554AII19-May-16SINTENOVO SA DE CVTOFACITINIB CITRATE
30617AII02-Aug-16SUN PHARMACEUTICAL INDUSTRIES LTDTOFACITINIB CITRATE
30621AII03-Aug-16MICRO LABS LTDTOFACITINIB CITRATE
30654AII05-Jul-16UNICHEM LABORATORIES LTDTOFACITINIB CITRATE
30686AII22-Jun-16OLON SPATOFACITINIB CITRATE
30578AII13-Jun-16QILU TIANHE PHARMACEUTICAL CO LTDTOFACITINIB CITRATE (NON-STERILE API)
30498AII19-Jul-16GLOCHEM INDUSTRIES LTDTOLCAPONE USP
30994AII30-Sep-16ALKEM LABORATORIES LTDTOLTERODINE TARTRATE USP
30640AII21-Jun-16ASYMCHEM LABORATORIES TIANJIN CO LTDTOREMIFENE CITRATE
30504AII22-Apr-16VIRUPAKSHA ORGANICS LTDTRAMADOL HYDROCHLORIDE
30535AII28-Apr-16EVERLIGHT CHEMICAL INDUSTRIAL CORPTREPROSTINIL DIOLAMINE
30861AII27-Sep-16ESJAY PHARMA LLCTREPROSTINIL SODIUM
28340AII15-Aug-16CHIROGATE INTERNATIONAL INCTREPROSTINIL SODIUM
30878A II09-Nov-16ESJAY PHARMA LLCTRIENTINE HYDROCHLORIDE USP
30905AII15-Sep-16NAVINTA LLCTRIENTINE HYDROCHLORIDE USP
30511A II05-Oct-16MORTON SALT INCUSP POTASSIUM CHLORIDE
30456AII29-Mar-16HIKAL LTDVALACYCLOVIR HYDROCHLORID USP
31002AII20-Sep-16CKD BIO CORPVANCOMYCIN HYDROCHLORIDE
30804A II02-Nov-16RAKS PHARMA PVT LTDVARDENAFIL HYDROCHLORIDE TRIHYDRATE USP
30451AII19-Apr-16MACLEODS PHARMACEUTICALS LTDVENLAFAXINE PROLONGED RELEASE PELLETS (37.5 MG/123 MG)
29849AII15-Aug-16ALP PHARM BEIJING CO LTDVORTIOXETINE HYDROBROMIDE
30409AII02-Jun-16PRAXAIR RARE GASES AND HELIUMXENON GAS FOR INHALATION, FOR CLINICAL TRIALS
31028AII30-Sep-16GLAND PHARMA LTDZIPRASIDONE MESILATE TRIHYDRATE
30781AII12-Aug-16CENTAUR PHARMACEUTICALS PRIVATE LTDZOLPIDEM TARTRATE USP
31009AII30-Sep-16MAITHRI DRUGS PRIVATE LTDZONISAMIDE USP