Visitor Monitoring Drug History: NABUMETONE
 
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Label and Approval History

Drug Name: NABUMETONE
FDA Application No: (ANDA) 075189
Active Ingredient(s): NABUMETONE
Company: TEVA
 
Label History
 
View the label approved on May 26, 2000 for NABUMETONE, (ANDA) 075189


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
5/21/2002 004Labeling  
6/21/2002 003Manufacturing Revision  
9/24/2001 002Labeling Letter 
9/24/2001 001Control Supplement Letter 
5/26/2000 000Approval Letter
Letter
Label
Review 
12/24/1998 000Tentative Approval Letter
Letter
Label
Review 
 
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