Visitor Monitoring Drug History: DAYTRANA
 
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Label and Approval History

Drug Name: DAYTRANA
FDA Application No: (NDA) 021514
Active Ingredient(s): METHYLPHENIDATE
Company: SHIRE
 
Label History
 
View the label approved on May 7, 2007 for DAYTRANA, (NDA) 021514


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
5/1/2007 005Labeling Revision Letter
Label 
7/27/2006 001Labeling Revision Letter
Label 
4/6/2006 000Approval Letter
Other Important Information from FDA 
 
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