Visitor Monitoring Drug History: ULTRAM ER
 
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Label and Approval History

Drug Name: ULTRAM ER
FDA Application No: (NDA) 021692
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
Company: BIOVAIL LABS INTL
 
Label History
 
View the label approved on August 4, 2006 for ULTRAM ER, (NDA) 021692


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
8/3/2006 002Labeling Revision Letter
Label 
6/5/2006 001Labeling Revision Letter 
9/8/2005 000Approval Letter
Label
Review 
 
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