DMF#STATUSTYPESUBMIT DATEHOLDERSUBJECT
30394AII3/2/2016NORTHERN CALIFORNIA PET IMAGING CENTERS(18F)-CP 18 POSITRON EMISSION TOMOGRAPHY IMAGING AGENT
30241AII1/27/2016HUANGGANG LUBAN PHARMACEUTICAL CO LTD3-(2-AMINO-2-OXOETHYL)-5-METHYLHEXANOIC ACID
29781AII2/18/2016JOHNSON MATTHEY PHARMA SERVICES4250.B (ETHACRYNIC ACID)
30155AII12/10/2015SUNBIO INC4-ARM POLYETHYLENE GLYCOL SUCCINIMIDYL GLUTARATE 10,000
30190AII1/7/2016MALLADI DRUGS AND PHARMACEUTICALS LTD6,7- DIMETHOXY- 3,4- DIHYDROISOQUINOLINE HYDROCHLORIDE
30302AII10/28/2015JENKEM TECHNOLOGY CO LTD8ARM PEG SUCCINIMIDYL GLUTARATE (HEXAGLYCEROL) MW 15000
30244AII2/3/2016MEGHMANI LLPACETAMINOPHEN USP
29645AII12/11/2015PFIZER INCACTIVATED CALICHEAMICIN DERIVATIVE
30057AII2/8/2016GLENMARK PHARMACEUTICALS LTDALOGLIPTIN BENZOATE
30198AII2/22/2016AMGEN INCAMG 282 DRUG SUBSTANCE
30439AII3/24/2016SUNNY PHARMTECH INCAMINOCAPROIC ACID, USP
29602AII2/25/2016NORAMCO INCAMPHETAMINE ASPARTATE
29601AII2/25/2016NORAMCO INCAMPHETAMINE SULFATE
30336AII3/14/2016DELMAR CHEMICALS INCAPIXABAN
30332AII3/29/2016MSN LIFE SCIENCES PRIVATE LTDAPREMILAST [ROUTE CODE LI]
30405AII3/31/2016PIRAMAL ENTERPRISES LTDARMODAFINIL
30227AII1/21/2016MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDATROPINE SULFATE
30104AII12/24/2015SHILPA MEDICARE LTDAXITINIB
30341AII3/4/2016MSN LABORATORIES PRIVATE LTDAXITINIB (FORM-XLI)[ROUTE CODE - "XB"]
29924AII3/11/2016GLENMARK PHARMACEUTICALS LTDAZELAIC ACID
30406AII3/14/2016IRVINE SCIENTIFIC SALES CO INCBALANCD? VERO (POWDER)
30077AII1/13/2016MSN LABORATORIES PRIVATE LTDBEXAROTENE [ROUTE CODE BX]
30157AII1/13/2016DSM NUTRITIONAL PRODUCTS LTDBIOTIN
30071AII1/26/2016HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDBIVALIRUDIN
30215AII3/9/2016SHENZHEN SALUBRIS PHARMACEUTICALS CO LTDBIVALIRUDIN
30264AII3/1/2016CIPLA LTDBORTEZOMIB
30278AII2/26/2016MSN LABORATORIES PRIVATE LTDBOSUTINIB (FORM-R) [ROUTE CODE "BY"]
30218AII2/5/2016MSN LABORATORIES PRIVATE LTDBOSUTINIB [ROUTE CODE BS]
29308AII5/6/2015QILU PHARMACEUTICAL CO LTDBOTEZOMIB (NON-STERILE FORM)
30366AII12/31/2015SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDCANAGLIFLOZIN
30240AII2/19/2016ALEMBIC PHARMACEUTICALS LTDCANDESARTAN CILEXETIL USP (CND PROCESS)
29750AII1/30/2016FRESENIUS KABI ONCOLOGY LTDCARFILZOMIB
30115AII3/22/2016LAURUS LABS PRIVATE LTDCARFILZOMIB
30124AII1/21/2016TEVA PHARMACEUTICAL INDUSTRIES LTDCARFILZOMIB
30402AII3/29/2016DR REDDYS LABORATORIES LTDCARFILZOMIB
30162AII12/29/2015CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDCARFILZOMIB (NON-STERILE BULK DRUG SUBSTANCE)
30357AII2/26/2016POLYMED THERAPEUTICS INCCARFILZOMIB DRUG SUBSTANCE
30112AII1/12/2016APOTEX PHARMACHEM INDIA PVT LTDCARVEDILOL DIHYDROGEN PHOSPHATE
30006AII12/23/2015CLEAVE BIOSCIENCES INCCB-5083 CAPSULES
29842AII1/14/2016NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCHCBD CANNABIS EXTRACT
30320AII2/22/2016COVALENT LABORATORIES PRIVATE LTDCEFDINIR HYDRATE USP
27384AII12/30/2015SAURAV CHEMICALS LTDCELECOXIB USP
30063AII2/1/2016GRANULES INDIA LTDCETIRIZINE HYDROCHLORIDE, USP
30237AII1/16/2016SHANGHAI LIVZON PHARMACEUTICAL CO LTDCHORIONIC GONADOTROPHIN
30183AII12/30/2015VIWIT PHARMACEUTICAL CO LTDCINACALCET HYDROCHLORIDE
30385AII3/31/2016UNICHEM LABORATORIES LTDCINACALCET HYDROCHLORIDE
29706AII8/13/2015GUANGZHOU HENOVCOM BIOSCIENCE CO LTDCLOFARABINE
30187AII2/15/2016SUN PHARMACEUTICAL INDUSTRIES LTDCLOPIDOGREL BISULFATE USP (PROCESS-II)
30404AII3/31/2016PIRAMAL ENTERPRISES LTDDABIGATRAN ETEXILATE MESYLATE
30107AII1/18/2016APICORE US LLCDACARBAZINE USP
30299AII2/29/2016MSN LABORATORIES PRIVATE LTDDAPAGLIFLOZIN (AMORPHOUS) [ROUTE CODE "DQa"]
29999AII3/31/2016TARO PHARMACEUTICAL INDUSTRIES LTDDAPSONE USP
30165AII12/29/2015HIKMA PHARMACEUTICALS PLCDASATINIB MONOHYDRATE
30219AII1/30/2016MSN LABORATORIES PRIVATE LTDDASATINIB PROPYLENE GLYCOL [ROUTE CODE DB]
30425AII3/21/2016OLON SPADAUNORUBICIN HYDROCHLORIDE
30213AII1/27/2016CTX LIFE SCIENCES PVT LTDDEFERASIROX
30313AII3/2/2016STERLING SPADEFLAZACORT
30447AII3/10/2016YICHENG GOTO PHARMACEUTICALS CO LTDDEHYDROEPIANDROSTERONE
30233AII2/19/2016AURO PEPTIDES LTDDESMOPRESSIN ACETATE USP
30437AII3/31/2016MSN LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE(FORM-1)[ROUTE CODE 'MD']
29603AII2/25/2016NORAMCO INCDEXTROAMPHETAMINE SACCHARATE
29604AII2/25/2016NORAMCO INCDEXTROAMPHETAMINE SULFATE
30384AII3/22/2016UNICHEM LABORATORIES LTDDIMETHYL FUMARATE
30091AII1/6/2016SCINOPHARM TAIWAN LTDDOCETAXEL USP
30055AII3/17/2016CIPLA LTDDOLUTEGRAVIR SODIUM
30365AII2/3/2016SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDDOLUTEGRAVIR SODIUM
30196AII2/9/2016S AND B PHARMA INC DBA NORAC PHARMADRONABINOL USP
30229AII1/22/2016SYMED LABS LTDDRONEDARONE HYDROCHLORIDE
30174AII3/7/2016ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE
30390AII3/31/2016ALEMBIC PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP
30172AII2/2/2016HEC PHARM CO LTDDULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE
30420AII3/30/2016MAITHRI DRUGS PRIVATE LTDEFINACONAZOLE [ROUTE CODE 'EC']
30338AII3/15/2016TIANJIN WEIJIE PHARMACEUTICAL CO LTDELETRIPTAN HYDROBROMIDE
30260AII3/17/2016SHILPA MEDICARE LTDENZALUTAMIDE
30304AII3/29/2016CADILA HEALTHCARE LTDENZALUTAMIDE
30279AII2/29/2016MSN LABORATORIES PRIVATE LTDENZALUTAMIDE [ROUTE CODE "EI"]
30392AII3/30/2016ALEMBIC PHARMACEUTICALS LTDERLOTINIB HYDROCHLORIDE
30123AII1/7/2016SUN PHARMACEUTICAL INDUSTRIES LTDERTAPENEM SODIUM
30311AII3/7/2016AUROBINDO PHARMA LTDERTAPENEM SODIUM
30222AII1/29/2016CTX LIFE SCIENCES PVT LTDESLICARBAZEPINE ACETATE
30401AII3/30/2016MSN LIFE SCIENCES PRIVATE LTDESOMEPRAZOLE MAGNESIUM USP (TRIHYDRATE) [ROUTE CODE 'EG']
30353AII3/30/2016JUBILANT GENERICS LTDFEBUXOSTAT
30199AII2/22/2016WISDOM PHARMACEUTICAL CO LTDFULVESTRANT INTERMEDIATE
30288AII2/29/2016AMRI INDIA PVT LTDFUROSEMIDE USP
28973AII4/2/2015SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDGANCICLOVIR
30393AII3/2/2016EVONIK REXIM NANNING PHARMACEUTICAL CO LTDGLYCINE
29908AII1/8/2016HUYA BIOSCIENCE INTERNATIONALHBI-8000 DRUG PRODUCT
30029AII2/12/2016HUBEI ENORAY BIOPHARMACEUTICAL CO LTDHEPARIN SODIUM USP
30158AII12/30/2015MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDHOMOHARRINGTONINE
30096AII1/15/2016HISAMITSU PHARMACEUTICAL CO INCHP-3070 (ASENAPINE MALEATE) TRANSDERMAL SYSTEM
30230AII1/21/2016ZHEJIANG XIANJU PHARMACEUTICAL CO LTDHYDROCORTISONE, NON-STERILE, BULK DRUG SUBSTANCE
29298AII4/15/2015SHANGHAI HAOYUAN CHEMEXPRESS CO LTDINTERMEDIATE OF CALCIPOTRIOL
29060AII2/2/2015LI-COR INCIRDYE 700DX CARBOXYLATE(DRUG SUBSTANCE INTERMEDIATE)
30380AII1/3/2016SNJ LABS PVT LTDIRON SUCROSE (PYROGEN FREE)
30205AII2/25/2016KAPPA BIOSCIENCE ASK2VITAL? MK-7
30160AII1/12/2016KISSEI PHARMACEUTICALS CO LTDKLH-2109 CHOLINE DRUG SUBSTANCE
30345AII2/25/2016HIKAL LTDLACOSAMIDE
30270AII2/2/2016SYN-TECH CHEM AND PHARM CO LTDLAMOTRIGINE USP
30185AII1/8/2016DIVIS LABORATORIES LTDLEVETIRACETAM (PROCESS B)
30119AII12/23/2015ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVETIRACETAM USP (PROCESS V)
30113AII3/1/2016APOTEX PHARMACHEM INDIA PVT LTDLEVOTHYROXINE SODIUM USP
30376AII3/22/2016LUPIN LTDLEVOTHYROXINE SODIUM USP
30274AII3/10/2016TEVA PHARMACEUTICAL INDUSTRIES LTDLINACLOTIDE
30421AII3/29/2016MSN LIFE SCIENCES PRIVATE LTDLINACLOTIDE [ROUTE CODE LE]
30272AII3/23/2016GLENMARK PHARMACEUTICALS LTDLOMITAPIDE MESYLATE
30154AII12/8/2015SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDLOPINAVIR
30277AII3/26/2016CADILA HEALTHCARE LTDLORCASERIN HYDROCHLORIDE
29910AII12/24/2015LUPIN LTDLORCASERIN HYDROCHLORIDE PREMIX
29339AII1/8/2016UNIV MISSOURI RESEARCH REACTOR CENTERLUTETIUM (LU-177) CHLORIDE RADIOPHARMACEUTICAL PRECURSOR
30212AII1/30/2016MSN LIFE SCIENCES PRIVATE LTDMACITENTAN [ROUTE CODE IM]
30284AII2/19/2016LONZA AGMC-VAL-ALA-PBD
29676AII1/12/2016SIGNA SA DE CVMESALAMINE USP
29997AII12/22/2015MACLEODS PHARMACEUTICALS LTDMETHIMAZOLE
30145AII12/22/2015JENKEM TECHNOLOGY CO LTDMETHOXY PEG SUCCINIMIDYL SUCCINATE MW20000
30238AII1/26/2016TIANJIN TIANYAO PHARMACEUTICALS CO LTDMETHYLPREDNISOLONE HEMISUCCINATE, USP BULK API
30310AII3/21/2016CENTAUR PHARMACEUTICALS PRIVATE LTDMETOLAZONE USP
30216AII2/1/2016TIANJIN WEIJIE PHARMACEUTICAL CO LTDMIDODRINE HYDROCHLORIDE BULK DRUG SUBSTANCE
30065AII1/29/2016GLENMARK PHARMACEUTICALS LTDMIRABEGRON
30086AII12/23/2015AUROBINDO PHARMA LTDMIRABEGRON
30105AII1/1/2016CADILA HEALTHCARE LTDMIRABEGRON
30169AII1/4/2016SHASUN PHARMACEUTICALS LTDMIRABEGRON
30291AII2/16/2016HETERO DRUGS LTDMIRABEGRON (FORM-B)
30153AII1/18/2016HONOUR LAB LTDMONOMETHYL FUMARATE
30207AII1/19/2016BIOVECTRA INCMPEG PROPIONALDEHYDE 20,000 DA
30292AII2/11/2016SYNGEN BIOTECH CO LTDMUPIROCIN
30246AII1/15/2016LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL NON-STERILE, BULK FORM
29553AII9/4/2015CONCORD BIOTECH LTDMYCOPHENOLATE MOFETIL USP (BY AZEOTROPIC DISTILLATION)
30259AII2/5/2016SANYO FINE CO LTDN-ACETYLNEURAMINIC ACID LYASE
29996AII2/19/2016MACLEODS PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE
28205AII12/29/2015CHEMWERTH INCNEPAFENAC STERILE BULK DRUG SUBSTANCE
30164AII12/29/2015HIKMA PHARMACEUTICALS PLCNILOTINIB MONOHYDROCHLORIDE ANHYDROUS
30352AII3/22/2016JUBILANT GENERICS LTDOLANZAPINE USP
30041AII1/28/2016LIANYUNGANG HONGCHUANG PHARMACEUTICAL CO LTDOLANZAPINE USP, NON-STERILE
30433AII3/22/2016HIKAL LTDOLMESARTAN MEDOXOMIL
30171AII1/28/2016HEC PHARM CO LTDOLMESARTAN MEDOXOMIL NON-STERILE BULK DRUG SUSTANCE
30412AII3/16/2016HETERO LABS LTDOSELTAMIVIR PHOSPHATE
30415AII3/31/2016EMCURE PHARMACEUTICALS LTDPALIPERIDONE
30202AII1/18/2016SAFC INCPEFCALCITOL
30243AII2/13/2016BIOPHORE INDIA PHARMACEUTICALS PVT LTDPERMETHRIN
30333AII3/3/2016HETERO LABS LTDPIOGLITAZONE HYDROCHLORIDE (PROCESS-II)
29289AII4/5/2015JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTDPNEUMOCANDIN B0
30408AII3/30/2016MSN LABORATORIES PRIVATE LTDPOMALIDOMIDE [ROUTE CODE "PO"]
29731AII2/10/2016ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPOSACONAZOLE
30083AII2/25/2016RAKS PHARMA PVT LTDPOTASSIUM DOBESILATE
30186AII3/7/2016PIRAMAL ENTERPRISES LTDPRAMIPEXOL DIHYDROCHLORIDE
30194AII12/24/2015ZHEJIANG XIANJU PHARMACEUTICAL CO LTDPREDNISONE, NON-STERILE, BULK DRUG SUBSTANCE
29073AII2/4/2015IRVINE SCIENTIFIC SALES CO INCPRIME-XV? FREEZIS DMSO-FREE
29074AII2/4/2015IRVINE SCIENTIFIC SALES CO INCPRIME-XV? IS21 SUPPLEMENT (50X) PRODUCT NUMBER 91142
29380AII5/11/2015IRVINE SCIENTIFIC SALES CO INCPRIME-XV? MSC EXPANSION XSFM
29281AII3/26/2015IRVINE SCIENTIFIC SALES CO INCPRIME-XV?T CELL EXPANSION XSFM
30211AII1/21/2016MEDTRONIC NEUROMODULATIONPROPRIETARY MEDTRONIC NEUROMODULATION INFORMATION REGARDING LIORESAL? INTRATHECAL (BACLOFEN INJECTION)
29736AII1/1/2016CADILA HEALTHCARE LTDRANOLAZINE (PROCESS II)
30423AII3/31/2016MSN PHARMACHEM PRIVATE LTDRILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]
30403AII3/31/2016PIRAMAL ENTERPRISES LTDRIVAROXABAN
30217AII2/1/2016EMCURE PHARMACEUTICALS LTDROPIVACAINE HYDROCHLORIDE USP (PROCESS II)
30387AII3/5/2016MELODY HEALTHCARE PVT LTDSALMETEROL XINAFOATE USP
29909AII1/14/2016STEMCENTRX INCSC-LD002 DRUG SUBSTANCE INTERMEDIATE
30181AII12/30/2015VIWIT PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE
30082AII12/22/2015JUBILANT GENERICS LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE
30170AII1/19/2016HEC PHARM CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE
30232AII1/26/2016SAFC INCSODIUM METAARSENITE
30383AII3/29/2016UNICHEM LABORATORIES LTDSOLIFENACIN SUCCINATE
30234AII2/23/2016TEVA PHARMACEUTICAL INDUSTRIES LTDSORAFENIB TOSYLATE
30235AII1/28/2016HETERO LABS LTDSORAFENIB TOSYLATE
30180AII1/30/2016MSN LABORATORIES PRIVATE LTDSORAFENIB TOSYLATE (FORM-III) [ROUTE CODE "SR"]
30192AII12/31/2015TIANJIN JINJIN PHARMACEUTICAL CO LTDSPIRONOLACTONE USP BULK API
30419AII3/18/2016ROVI CONTRACT MANUFACTURING SLSTERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGE
30056AII2/3/2016ZHEJIANG HAISEN PHARMACEUTICAL CO LTDSUCRALFATE NON STERILE BULK DRUG SUBSTANCE
30110AII12/11/2015ZHEJIANG JINHUA CONBA BIO PHARM CO LTDTAMSULOSIN HYDROCHLORIDE
30355AII2/20/2016QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE
30220AII3/10/2016PHARMAZELL GMBHTERIFLUNOMIDE
30297AII3/5/2016BIOCON LTDTERIFLUNOMIDE
30340AII3/15/2016AUROBINDO PHARMA LTDTERIFLUNOMIDE
30346AII3/7/2016OLON SPATERIFLUNOMIDE
30414AII3/29/2016EMCURE PHARMACEUTICALS LTDTERIFLUNOMIDE
28898AII3/16/2016ALEMBIC PHARMACEUTICALS LTDTERIFLUNOMIDE
30074AII12/11/2015ABX ADVANCED BIOCHEMICAL COMPOUNDS GMBHTETRAKIS (2-METHOXY-ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROBORATE
30424AII3/31/2016MSN LABORATORIES PRIVATE LTDTHIOTEPA USP [ROUTE CODE "ZT"]
30109AII1/4/2016KREITCHMAN PET CENTERTHK-5351 F18 INJECTION
30422AII3/31/2016MAITHRI DRUGS PRIVATE LTDTIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
29726AII1/20/2016LUPIN LTDTIOTROPIUM BROMIDE MONOHYDRATE
30106AII1/12/2016DR REDDYS LABORATORIES LTDTREPROSTINIL
30314AII2/29/2016MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE (CRYSTALLINE) [ROUTE CODE "VM"]
30364AII3/11/2016DEBIOPHARM RESEARCH AND MANUFACTURING SATRIPTORELIN PAMOATE MICROGRANULES
30051AII11/10/2015KANEKA CORPORATION JAPANUBIDECARENONE
30242AII2/19/2016CHEMPACIFIC CORPV091015 DRUG SUBSTANCE
28969AII4/2/2015SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDVALACYCLOVIR HYDROCHLORIDE
28824AII3/31/2016IPCA LABORATORIES LTDVALSARTAN USP
30182AII12/22/2015VIWIT PHARMACEUTICAL CO LTDVARENICLINE TARTRATE
30309AII3/10/2016MSN PHARMACHEM PRIVATE LTDVORTIOXETINE HYDROBROMIDE [ROUTE CODE "VX"]