ABIRATERONE ACETATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26894
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Oral Grade - pdf
Filling Details ABIRATERONE ACETATE    
Issue/Submission date 2014-07-30    
Amifostine Trihydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Amikacin Sulfate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable, Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
Amphotericin B USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
ANAGRELIDE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16440
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Oral Grade - pdf
Filling Details ANAGRELIDE HYDROCHLORIDE MONOHYDRATE    
Issue/Submission date 2003-02-25    
ARGATROBAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 20709
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE    
Issue/Submission date 2007-07-20    
ARGATROBAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22855
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details INTERMEDIATE 6 OF ARGATROBAN (ARGA 6)    
Issue/Submission date 2009-08-14    
Argatroban Monohydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
ARSENIC TRIOXIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26075
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG SUBSTANCE    
Issue/Submission date 2012-05-18    
Asenapine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
AZACITIDINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 23416
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Injectable Grade - pdf
Filling Details AZACITIDINE NON-STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2009-12-22    
Aztreonam USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Bivalirudin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
BOSENTAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29001
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Oral Grade - pdf
Filling Details BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2015-03-03    
BROMFENAC SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 24521
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details BROENAC SODIUM (SESQUIHYDRATE)    
Issue/Submission date 2011-05-20    
BUSULFAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 25667
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details BUSULFAN USP NON-STERILE BULK DRUG    
Issue/Submission date 2012-02-02    
Cangrelor USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
CARBAMAZEPINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 7904
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details CARBAMAZEPINE    
Issue/Submission date 1989-02-01    
Carprofen USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
Clindamycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
Clocortolon USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
CLOCORTOLONE PIVALATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 25138
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details CLOCORTOLONE PIVALATE    
Issue/Submission date 2011-09-09    
CYCLOSPORINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 13789
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable,Oral, Veterinary Grade - pdf
Filling Details CYCLOSPORINE    
Issue/Submission date 1998-09-01    
Daptomycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
DAUNORUBICIN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 17218
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE)    
Issue/Submission date 2004-03-04    
Degarelix Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
DEXMEDETOMIDINE HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 24202
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details DEXMEDETOMIDINE HCL    
Issue/Submission date 2011-12-15    
DIFLUPREDNATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26378
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details DIFLUPREDNATE    
Issue/Submission date 2013-07-22    
Disodium pamidronate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 12803
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details PAMIDRONIC ACID    
Issue/Submission date 1997-12-22    
Dobutamine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 8856
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DOBUTAMINE HYDROCHLORIDE    
Issue/Submission date 1990-11-20    
doramectin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Doxcercalciferol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable, Oral Grade - pdf
Filling Details    
Issue/Submission date    
DOXORUBICIN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 18462
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE)    
Issue/Submission date 2005-06-29    
DOXYCYCLINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 7281
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DOXYCYCLINE MONOHYDRATE    
Issue/Submission date 1988-01-05    
DRONEDARONE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26479
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG    
Issue/Submission date 2013-05-02    
Droxidopa USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Enoxaparin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
EPINASTINE HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 21974
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Injectable Grade - pdf
Filling Details EPINASTINE HCL    
Issue/Submission date 2008-12-30    
Eptifibatide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Eslicarbazepine Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
ESMOLOL HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16053
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details ESMOLOL HCL    
Issue/Submission date 2002-06-27    
ETHACRYNATE SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26338
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ETHACRYNATE SODIUM NON-STERILE, BULK DRUG    
Issue/Submission date 2013-03-01    
ETHACRYNIC ACID USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26337
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ETHACRYNIC ACID USP NON-STERILE BULK DRUG    
Issue/Submission date 2013-01-31    
Ethosuximide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
ETOMIDATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 20500
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2007-04-30    
Etoposide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Everolimus USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Febuxostat USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
FENOLDOPAM MESYLATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16582
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2003-05-12    
florfenicol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
FOSAPREPITANT DIMEGLUMINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
FOSCARNET SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28996
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details FOSCARNET SODIUM USP    
Issue/Submission date 2015-01-30    
Gemcitabine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Heparin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
ICATIBANT ACETATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Ifosfamide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
imidacloprid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
IMIQUIMOD USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 20931
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details IMIQUIMOD, NON-STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2007-10-08    
inamrinone USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 13087
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details INAMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE    
Issue/Submission date 1998-07-24    
Irinotecan Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 17348
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details IRINOTECAN HCL (NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2004-05-13    
IRON SUCROSE COMPLEX USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
ISRADIPINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 20749
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details ISRADIPINE USP, NON-STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2007-08-02    
Ivermectin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
KETOTIFEN HYDROGEN FUMARATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 20661
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details KETOTIFEN HYDROGEN FUMARATE    
Issue/Submission date 2007-08-02    
Lanreotide Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Lincomycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
Lipiarmycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Liraglutide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Lovastatine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 17821
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details LOVASTAIN (NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2004-11-01    
lufenuron USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
Luliconazole USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
maropitant citrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
MELPHALAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 21237
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details MELPHALON USP    
Issue/Submission date 2008-01-11    
MELPHALAN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 25644
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE    
Issue/Submission date 2011-12-29    
Methotrexate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
milbemycin oxime USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Veterinary Grade - pdf
Filling Details    
Issue/Submission date    
MILRINONE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 13195
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details MILRINONE, NON-STERILE BULK DRUG    
Issue/Submission date 1998-09-23    
nepafenac USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 25528
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Injectable Grade - pdf
Filling Details NEPAFENAC    
Issue/Submission date 2014-12-17    
Nepafenac USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28205
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Injectable Grade - pdf
Filling Details NEPAFENAC STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2015-12-29    
NICARDIPINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 19552
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE    
Issue/Submission date 2006-06-26    
OCTREOTIDE ACETATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Orgalutran USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Oxaliplatin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Oxybutynin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Pamidronate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Parathar Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
Paricalcitol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable, Oral Grade - pdf
Filling Details    
Issue/Submission date    
PEMETREXED USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 23417
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE    
Issue/Submission date 2009-12-28    
Pitavastatin Calcium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
PROPANTHELINE BROMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 7691
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details PROPANTHELINE BROMIDE    
Issue/Submission date 1988-09-26    
REPAGLINIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 18003
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details REPAGLINIDE USP    
Issue/Submission date 2005-01-12    
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R0-CEP 2013-248-Rev 00
Status VALID   Commercial Stage API- Injectable Grade - pdf
Filling Details Ropivacaine hydrochloride monohydrate    
Issue/Submission date 2016-01-08    
Sacubitril USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
selamectin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
SIROLIMIUS USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16890
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Oral Grade - pdf
Filling Details SIROLIMUS    
Issue/Submission date 2003-10-01    
SODIUM NITROPRUSSIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29723
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details SODIUM NITROPRUSSIDE    
Issue/Submission date 2015-09-30    
SODIUM TETRADECYL SULFATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16483
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details SODIUM TETRADECYL SULFATE (STDS)(NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2003-03-25    
Solifenacin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
Spinosyn D USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
TACROLIMUS USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 21808
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details TACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE    
Issue/Submission date 2008-07-16    
Teduglutide Recombinant USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
TEMOZOLOMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 23547
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Injectable, Oral Grade - pdf
Filling Details TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2010-02-17    
TETRABENAZINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 24946
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Commercial Stage API- Oral Grade - pdf
Filling Details TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE)    
Issue/Submission date 2011-10-18    
Thiotepa USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
TIAGABINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22033
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Oral Grade - pdf
Filling Details TIAGABINE HYDROCHLORIDE    
Issue/Submission date 2008-09-23    
TOBRAMYCIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2006-188-Rev 01
Status VALID   Commercial Stage API- Injectable Grade - pdf
Filling Details Tobramycin Form I    
Issue/Submission date 2016-02-09    
Topiramate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
TOPOTECAN HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22859
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Commercial Stage API- Injectable Grade - pdf
Filling Details TOPOTECAN HCL    
Issue/Submission date 2010-06-30    
Treprostinil USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Treprostinil Diolamine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Oral Grade - pdf
Filling Details    
Issue/Submission date    
Trientine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29019
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details TRIENTINE HYDROCHLORIDE USP    
Issue/Submission date 2015-09-25    
Trilostane USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
tulathromycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
U 62840 USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Vancomycin Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Vasopressin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
VINCRISTINE SULFATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 6221
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details VINCRISTINE SULFATE    
Issue/Submission date 1986-02-17    
Vinorelbine Tartrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   Commercial Stage API- Injectable Grade - pdf
Filling Details    
Issue/Submission date    
Ziprasidone Mesylate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number
Status   API Under Development - pdf
Filling Details    
Issue/Submission date    
USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30652
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ISOPROTERENOL HCL USP    
Issue/Submission date 2016-09-15