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
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Amikacin Sulfate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable, Veterinary Grade - pdf
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Amphotericin B USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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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 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 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 Monohydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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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
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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
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Bivalirudin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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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 BROMFENAC 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
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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
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Clindamycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Veterinary Grade - pdf
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clocortolone acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Oral Grade - pdf
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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
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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
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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
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Doxcercalciferol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable, Oral Grade - pdf
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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
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Enoxaparin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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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
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Eslicarbazepine Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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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
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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
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Issue/Submission date    
Everolimus USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Issue/Submission date    
Febuxostat USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Oral Grade - pdf
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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
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FOSAPREPITANT DIMEGLUMINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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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
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Heparin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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ICATIBANT ACETATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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Ifosfamide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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Issue/Submission date    
imidacloprid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Veterinary Grade - pdf
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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
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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
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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
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Lincomycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Veterinary Grade - pdf
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Lipiarmycin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Liraglutide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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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
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Issue/Submission date    
Luliconazole USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Issue/Submission date    
maropitant citrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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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, NON-STERILE, BULK DRUG SUBSTANCE    
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
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Issue/Submission date    
milbemycin oxime USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Veterinary Grade - pdf
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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
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Orgalutran USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Oxaliplatin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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Oxybutynin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Pamidronate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable Grade - pdf
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Parathar Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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Paricalcitol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Commercial Stage API- Injectable, Oral Grade - pdf
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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
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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
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selamectin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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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
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Spinosyn D USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   API Under Development - pdf
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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
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TEMOZOLOMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 23547  
Status DMF Status - Active
GDUFA Facility Fees - Paid
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  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
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Issue/Submission date 2011-10-18    
Thiotepa USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   API Under Development - pdf
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TIAGABINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22033  
Status DMF Status - Active
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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
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Issue/Submission date 2016-02-09    
Topiramate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   Commercial Stage API- Oral Grade - pdf
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TOPOTECAN HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22859  
Status DMF Status - Active
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  Commercial Stage API- Injectable Grade - pdf
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Issue/Submission date 2010-06-30    
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Status   Commercial Stage API- Injectable Grade - pdf
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Treprostinil Diolamine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   Commercial Stage API- Oral Grade - pdf
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Trientine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29019  
Status DMF Status - Active
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Issue/Submission date 2015-09-25    
Trilostane USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   API Under Development - pdf
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Status   API Under Development - pdf
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U 62840 USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   Commercial Stage API- Injectable Grade - pdf
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Status   Commercial Stage API- Injectable Grade - pdf
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Vasopressin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   API Under Development - pdf
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VINCRISTINE SULFATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 6221  
Status DMF Status - Inactive
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Issue/Submission date 1986-02-17    
Vinorelbine Tartrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   Commercial Stage API- Injectable Grade - pdf
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Ziprasidone Mesylate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
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Status   API Under Development - pdf
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USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30652  
Status DMF Status - Active
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Issue/Submission date 2016-09-15