Visitor Monitoring Drug History: DEPAKOTE ER
 
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Label and Approval History

Drug Name: DEPAKOTE ER
FDA Application No: (NDA) 021168
Active Ingredient(s): DIVALPROEX SODIUM
Company: ABBOTT
 
Label History
 
View the label approved on October 18, 2006 for DEPAKOTE ER, (NDA) 021168


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
10/13/2006 014Labeling Revision Letter
Label 
12/6/2005 012New or Modified Indication Letter
Label 
1/11/2006 009Labeling Revision Letter
Label 
4/20/2003 008Control Supplement  
8/14/2003 007Patient Population Altered Letter
Label
Review 
12/20/2002 004Labeling Revision Letter
Label
Review 
12/12/2002 003Labeling Revision Letter 
5/31/2002 001Manufacturing Change or Addition Letter
Label 
8/4/2000 000Approval Letter
Label
Review 
 
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