Visitor Monitoring Drug History: OMACOR
 
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Label and Approval History

Drug Name: OMACOR
FDA Application No: (NDA) 021853
Active Ingredient(s): OMEGA-3ACID ETHYL ESTERS
Company: RELIANT PHARMS
 
Label History
 
Labels are not available on this site for OMACOR, (NDA) 021853
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/12/2007 000Approval Letter
Consumer Information Sheet 
 
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