PENICILLIN G POTASSIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 16837
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details PENICILLIN G POTASSIUM    
Issue/Submission date 2003-09-15    
PENICILLIN G PROCAINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 14400
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details PENICILLIN G PROCAINE    
Issue/Submission date 1999-09-10    
PENICILLIN V POTASSIUM USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 13963 R1-CEP 1997-043-Rev 02
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
VALID  
Filling Details PENICILLIN V POTASSIUM Phenoxymethylpenicillin potassium    
Issue/Submission date 1999-01-29 2008-02-08    
POLYMYXIN B SULFATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 23876 R0-CEP 2011-166-Rev 01 CoA - pdf
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
VALID  
Filling Details POLYMYXIN B SULFATE Polymyxin B sulfate Micronised    
Issue/Submission date 2010-05-31 2014-04-17