Visitor Monitoring Drug History: UNIVASC
 
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Label and Approval History

Drug Name: UNIVASC
FDA Application No: (NDA) 020312
Active Ingredient(s): MOEXIPRIL HYDROCHLORIDE
Company: SCHWARZ PHARMA
 
Label History
 
Labels are not available on this site for UNIVASC, (NDA) 020312
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/29/2003 024Labeling Revision Letter 
12/9/2002 019Package Change  
10/2/2001 018Control Supplement  
9/24/2001 017Control Supplement  
4/11/2001 016Labeling Revision Letter 
3/28/2001 015Package Change  
2/2/2000 014Labeling Revision  
7/18/2000 013Manufacturing Change or Addition  
10/29/1999 012Manufacturing Change or Addition  
2/11/1999 011Manufacturing Change or Addition  
4/8/1998 010Labeling Revision  
9/3/1998 009Manufacturing Change or Addition  
11/8/1996 008Control Supplement  
9/3/1996 007Package Change  
7/9/1996 006Control Supplement  
1/17/1996 005Manufacturing Change or Addition  
10/18/1995 004Package Change  
10/18/1995 002Manufacturing Change or Addition  
10/18/1995 001Control Supplement  
4/19/1995 000Approval Review
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