Visitor Monitoring Drug History: AFEDITAB CR
 
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Label and Approval History

Drug Name: AFEDITAB CR
FDA Application No: (ANDA) 075128
Active Ingredient(s): NIFEDIPINE
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for AFEDITAB CR, (ANDA) 075128
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/30/2002 006Control Supplement  
7/17/2002 004Control Supplement  
7/17/2002 003Manufacturing Revision  
1/17/2002 002Facility Addition  
7/23/2001 001Packager Addition  
3/10/2000 000Approval Letter
Letter
Review 
5/28/1999 000Tentative Approval Letter
Letter
Review 
 
Therapeutic Equivalents
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