Acrivastine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29830  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ACRIVASTINE    
Issue/Submission date 2015-09-29    
ALOSETRON HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27470  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ALOSETRON HYDROCHLORIDE    
Issue/Submission date 2013-09-23    
BENDAMUSTINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27483  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE    
Issue/Submission date 2013-09-20    
BORTEZOMIB USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29506  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details BORTEZOMIB    
Issue/Submission date 2015-08-27    
CHLORAMBUCIL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28956  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details CHLORAMBUCIL    
Issue/Submission date 2015-05-25    
CLOFARABINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27901  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details CLOFARABINE    
Issue/Submission date 2014-02-05    
Clomipramine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30814  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details CLOMIPRAMINE HYDROCHLORIDE    
Issue/Submission date 2016-08-20    
D-Penicillamine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30833  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details D-PENICILLAMINE    
Issue/Submission date 2016-09-28    
DECITABINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29697  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details DECITABINE    
Issue/Submission date 2015-09-30    
Diatrizoate Meglumine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28740  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details DIATRIZOATE MEGLUMINE    
Issue/Submission date 2014-10-31    
Diatrizoate sodium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28739  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details DIATRIZOATE SODIUM    
Issue/Submission date 2014-11-05    
dimethyl fumarate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28955  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details DIMETHYL FUMARATE    
Issue/Submission date 2015-01-09    
DOTA USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30539  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DOTA    
Issue/Submission date 2016-08-10    
ETHACRYNATE SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30813  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details ETHACRYNATE SODIUM    
Issue/Submission date 2016-09-19    
ETHACRYNIC ACID USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29429 CoA - pdf  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ETHACRYNIC ACID    
Issue/Submission date 2015-06-06    
Ferric Citrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30835  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details FERRIC CITRATE    
Issue/Submission date 2016-09-28    
Frovatriptan Succinate Hydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27284  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details FROVATRIPTAN SUCCINATE MONOHYDRATE    
Issue/Submission date 2013-07-16    
ICATIBANT ACETATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30526  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details ICATIBANT ACETATE    
Issue/Submission date 2016-09-27    
Isoproterenol Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30811  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ISOPROTERENOL HYDROCHLORIDE    
Issue/Submission date 2016-08-13    
ISOSULFAN BLUE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29829  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ISOSULFAN BLUE    
Issue/Submission date 2015-09-29    
ISOTRETINOIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27484  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ISOTRETINOIN    
Issue/Submission date 2013-09-27    
LEVOTHYROXINE SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29098  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details LEVOTHYROXINE SODIUM    
Issue/Submission date 2015-03-14    
LIOTHYRONINE SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30942  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details LIOTHYRONINE SODIUM    
Issue/Submission date 2016-09-30    
MELPHALAN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28300  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details MELPHALAN    
Issue/Submission date 2014-05-24    
MELPHALAN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27485  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details MELPHALAN HYDROCHLORIDE    
Issue/Submission date 2013-09-28    
NILUTAMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 28262  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details NILUTAMIDE    
Issue/Submission date 2014-06-23    
PENTETIC ACID USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 25457  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details PENTETIC ACID    
Issue/Submission date 2011-10-17    
Permethrin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30243  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details PERMETHRIN    
Issue/Submission date 2016-02-13    
PHYTONADIONE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26447  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details PHYTONADIONE    
Issue/Submission date 2012-09-26    
PHYTONADIONE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27805  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details PHYTONADIONE ROUTE-B    
Issue/Submission date 2013-12-28    
PLERIXAFOR USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29507  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details PLERIXAFOR    
Issue/Submission date 2015-07-04    
Regadenoson USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30834  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details REGADENOSON    
Issue/Submission date 2016-09-13    
SILDENAFIL CITRATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29831  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details SILDENAFIL CITRATE    
Issue/Submission date 2015-09-29    
SODIUM NITROPRUSSIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29647  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details SODIUM NITROPRUSSIDE    
Issue/Submission date 2015-09-25    
Taurolidine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0273  
Status   Valid - 2017-04-15
Filling Details Taurolidine    
Issue/Submission date 2014-04-16    
THIAMINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27482  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details THIAMINE HYDROCHLORIDE    
Issue/Submission date 2013-09-29    
TRETINOIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26922  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details TRETINOIN    
Issue/Submission date 2013-03-30    
Trientine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29527  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details TRIENTINE HYDROCHLORIDE    
Issue/Submission date 2015-09-03    
ZILEUTON USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 26446  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
 
Filling Details ZILEUTON    
Issue/Submission date 2012-09-26    
Zofenopril Calcium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0273  
Status   Valid - 2017-04-15
Filling Details Zofenopril Calcium    
Issue/Submission date 2014-04-16