Visitor Monitoring Drug History: NIFEDIPINE
 
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Label and Approval History

Drug Name: NIFEDIPINE
FDA Application No: (ANDA) 075269
Active Ingredient(s): NIFEDIPINE
Company: BIOVAIL
 
Label History
 
Labels are not available on this site for NIFEDIPINE, (ANDA) 075269
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/16/2002 006Supplier Addition  
7/15/2002 005Control Supplement  
12/28/2001 003Control Supplement  
7/15/2002 002Control Supplement  
2/14/2002 001Facility Addition  
12/4/2000 000Approval Letter
Letter
Review 
6/29/1999 000Tentative Approval Letter
Letter
Review 
 
Therapeutic Equivalents
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