Acitretin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
Filling Details ACRIVASTINE    
Issue/Submission date 2015-09-29    
AGOMELATINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations Complete - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
Filling Details ALOSETRON HYDROCHLORIDE    
Issue/Submission date 2013-09-23    
Aminocaproic Acid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Belinostat USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  EU DMF- Available - pdf
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
  Product Presentation - pdf
Filling Details BORTEZOMIB    
Issue/Submission date 2015-08-27    
Carfilzomib USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  EU DMF- Available - pdf
Filling Details CHLORAMBUCIL    
Issue/Submission date 2015-05-25    
Chlorpromazine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Product Presentation - pdf
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 - Complete
  Product Presentation - pdf
Filling Details D-PENICILLAMINE    
Issue/Submission date 2016-09-28    
Dantrolene Sodium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
Filling Details DECITABINE    
Issue/Submission date 2015-09-30    
Degarelix Acetate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Desipramine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Product Presentation - pdf
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
  Product Presentation - pdf
Filling Details DIMETHYL FUMARATE    
Issue/Submission date 2015-01-09    
Docosanol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations Complete - pdf
Filling Details    
Issue/Submission date    
Dofetilide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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    
eliglustat USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
ETHACRYNATE SODIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30813 CoA - pdf  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Product Presentation - pdf
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
  Product Presentation - pdf
Filling Details ETHACRYNIC ACID    
Issue/Submission date 2015-06-06    
Feraheme USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Ferric Carboxymaltose USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Health Canada- Approved - pdf
Filling Details FROVATRIPTAN SUCCINATE MONOHYDRATE    
Issue/Submission date 2013-07-16    
Gadobenic Acid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
GADOPENTETATE DIMEGLUMINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Gadoteric acid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EU DMF- Available; Swissmedic- Approved - pdf
Filling Details    
Issue/Submission date    
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 - Complete
  Product Presentation - pdf
Filling Details ICATIBANT ACETATE    
Issue/Submission date 2016-09-27    
Idelalisib USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Indigo Carmine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Iohexol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
Iopamidol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Product Presentation - pdf
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
  Product Presentation - pdf
Filling Details ISOTRETINOIN    
Issue/Submission date 2013-09-27    
Levothyroxine Sodium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Product Presentation - pdf
Filling Details MELPHALAN HYDROCHLORIDE    
Issue/Submission date 2013-09-28    
Methazolamide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Methylene Blue USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Metolazone USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
Nadolol USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
Filling Details NILUTAMIDE    
Issue/Submission date 2014-06-23    
Olsalazine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
palbociclib USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Pasireotide Diaspartate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
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
  EU DMF- Available - pdf
Filling Details PERMETHRIN    
Issue/Submission date 2016-02-13    
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
  SFDA- Approved - pdf
Filling Details PHYTONADIONE ROUTE-B    
Issue/Submission date 2013-12-28    
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
  SFDA- Approved - pdf
Filling Details PHYTONADIONE    
Issue/Submission date 2012-09-26    
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
  Product Presentation - pdf
Filling Details PLERIXAFOR    
Issue/Submission date 2015-07-04    
Procainamide Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Prochlorperazine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Prochlorperazine Edisylate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Prochlorperazine Maleate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
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 - Complete
  Product Presentation - pdf
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    
Sildenafil Citrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Sincalide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations Complete - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
Filling Details SODIUM NITROPRUSSIDE    
Issue/Submission date 2015-09-25    
Succinylcholine Chloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Sucralfate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Sulfobutyl ether beta-cyclodextrin sodium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Taurolidine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0273  
Status   Expired - 2017-04-15
Filling Details Taurolidine    
Issue/Submission date 2014-04-16    
Taurolidine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EU DMF- Available - pdf
Filling Details    
Issue/Submission date    
Tavaborole USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Temozolomide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EU DMF- Available; Health Canada, Swissmedic- Approved - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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
  Product Presentation - pdf
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
  Product Presentation - pdf
Filling Details TRIENTINE HYDROCHLORIDE    
Issue/Submission date 2015-09-03    
Triferic USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Developed - pdf
Filling Details    
Issue/Submission date    
Triiodothyronine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Velphoro USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
Velphoro USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validations - pdf
Filling Details    
Issue/Submission date    
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
  Product Presentation - pdf
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   Expired - 2017-04-15
Filling Details Zofenopril Calcium    
Issue/Submission date 2014-04-16    
Zofenopril Calcium USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EU DMF- Available - pdf
Filling Details    
Issue/Submission date