Alfuzosin Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
Filling Details    
Issue/Submission date    
AMILORIDE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 1998-015-Rev 04  
Status VALID   EDMF Available - pdf
Filling Details Amiloride hydrochloride dihydrate    
Issue/Submission date 2010-06-15    
Aprepitant USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   R&D Samples Available - pdf
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BACLOFEN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R0-CEP 2011-360-Rev 00  
Status VALID   EDMF Available - pdf
Filling Details Baclofen    
Issue/Submission date 2013-05-29    
Citalopram Hydrobromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
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Disodium Pamidronate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 218MF10468  
Status   EDMF Available - pdf
Filling Details Pamidronate disodium succinate at VIA DE AMBROSIIS N. 2/4 / 6-15067 NOVI LIGURE (ALESSANDRIA) ITALY    
Issue/Submission date 2006-04-27    
DOBUTAMINE HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2004-261-Rev 00  
Status VALID   EDMF Available - pdf
Filling Details Dobutamine hydrochloride    
Issue/Submission date 2012-05-10    
Escitalopram Oxalate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
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FOSAPREPITANT DIMEGLUMINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   R&D - pdf
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Gabexate Mesylate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
Filling Details    
Issue/Submission date    
HYALURONIDASE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2001-068-Rev 00  
Status VALID  
Filling Details Hyaluronidase    
Issue/Submission date 2007-04-04    
INDAPAMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 9026 R1-CEP 1998-075-Rev 02  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
VALID   EDMF Available - pdf
Filling Details INDAPAMIDE Indapamide    
Issue/Submission date 1991-03-28 2006-03-30    
Levodropropizine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R0-CEP 2013-156-Rev 00  
Status VALID   EDMF Available - pdf
Filling Details Levodropropizine    
Issue/Submission date 2015-03-16    
Linezolid USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Validation Batches Ready. DMF in Preparation - pdf
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PRAZOSIN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 15321 R1-CEP 2004-221-Rev 00  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
VALID   EDMF Available - pdf
Filling Details PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE Prazosin hydrochloride    
Issue/Submission date 2001-02-28 2011-02-09    
Sildenafil Citrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
Filling Details    
Issue/Submission date    
Silodosin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   R&D Samples Available for Beta Form. Validation Batches 2016 - pdf
Filling Details    
Issue/Submission date    
TAMSULOSIN HYDROCHLORIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2008-297-Rev 00  
Status VALID   EDMF Available - pdf
Filling Details Tamsulosin hydrochloride    
Issue/Submission date 2015-02-18    
Tazarotene USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
Filling Details    
Issue/Submission date    
TERAZOSIN HCI. 2H20 USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 12424  
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  EDMF Available - pdf
Filling Details TERAZOSIN HCI. 2H20 BULK SUBSTANCE    
Issue/Submission date 1997-03-17    
TERAZOSIN HYDROCHLORIDE DIHYDRATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 12802  
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  EDMF Available - pdf
Filling Details TERAZOSIN HCL 2H20    
Issue/Submission date 1997-12-22    
TERAZOSIN HYDROCHLORIDE DIHYDRATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 14916  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  EDMF Available - pdf
Filling Details TERAZOSIN HCL. 2H2O    
Issue/Submission date 2000-06-12    
TORSEMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 19237 R1-CEP 2008-251-Rev 00  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
VALID   EDMF Available - pdf
Filling Details TORSEMIDE (MOD 1) BULK SUBSTANCE Torasemide    
Issue/Submission date 2006-03-08 2015-04-13    
TRIPROLIDINE HCL MONOHYDRATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   EDMF Available - pdf
Filling Details    
Issue/Submission date    
USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 8567  
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FRESONARA, ITALY.    
Issue/Submission date 1990-05-09