Visitor Monitoring Drug History: OMEPRAZOLE
 
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Label and Approval History

Drug Name: OMEPRAZOLE
FDA Application No: (ANDA) 075347
Active Ingredient(s): OMEPRAZOLE
Company: ANDRX PHARMS
 
Label History
 
Labels are not available on this site for OMEPRAZOLE, (ANDA) 075347
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/4/2002 005Labeling  
10/4/2002 004Packaging Addition  
12/24/2002 002Packager Addition  
7/31/2002 001Packager Addition  
11/16/2001 000Approval Letter
Letter
Review 
3/23/2000 000Tentative Approval Letter
Letter
Review 
2/1/2005 000Tentative Approval Letter
Letter
Review 
 
Therapeutic Equivalents
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