Visitor Monitoring Drug History: OMNITROPE
 
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Label and Approval History

Drug Name: OMNITROPE
FDA Application No: (NDA) 021426
Active Ingredient(s): SOMATROPIN RECOMBINANT
Company: SANDOZ
 
Label History
 
View the label approved on May 31, 2006 for OMNITROPE, (NDA) 021426


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/30/2006 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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