Visitor Monitoring Drug History: ACETADOTE
 
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Label and Approval History

Drug Name: ACETADOTE
FDA Application No: (NDA) 021539
Active Ingredient(s): ACETYLCYSTEINE
Company: CUMBERLAND PHARMS
 
Label History
 
View the label approved on February 22, 2006 for ACETADOTE, (NDA) 021539


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
2/14/2006 004Labeling Revision Letter
Label 
4/28/2004 002Labeling Revision Letter
Label 
4/28/2004 001Labeling Revision Letter
Label 
1/23/2004 000Approval Letter
Label
Review 
 
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