Visitor Monitoring Drug History: MARINOL
 
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Label and Approval History

Drug Name: MARINOL
FDA Application No: (NDA) 018651
Active Ingredient(s): DRONABINOL
Company: UNIMED
 
Label History
 
View the label approved on June 28, 2006 for MARINOL, (NDA) 018651


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
6/21/2006 026Labeling Revision Letter
Label 
6/21/2006 025Labeling Revision Letter
Label 
4/26/2005 021Labeling Revision Letter
Label 
5/21/2004 020Manufacturing Change or Addition  
4/28/2003 018Labeling Revision Letter
Label 
9/6/2002 017Control Supplement  
9/6/2002 016Control Supplement  
1/17/2002 015Manufacturing Change or Addition  
4/5/2001 014Manufacturing Change or Addition  
9/22/2000 013Labeling Revision  
6/21/2000 012Manufacturing Change or Addition  
8/5/1999 011Labeling Revision Review 
10/30/2001 010Manufacturing Change or Addition  
3/5/2002 009Manufacturing Change or Addition  
12/22/1992 006New or Modified Indication  
3/3/1992 005Manufacturing Change or Addition  
3/31/1993 004Control Supplement  
3/31/1989 003Control Supplement  
1/28/1986 001Labeling Revision  
5/31/1985 000Approval  
 
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