Visitor Monitoring Drug History: ACTIQ
 
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Label and Approval History

Drug Name: ACTIQ
FDA Application No: (NDA) 020747
Active Ingredient(s): FENTANYL CITRATE
Company: CEPHALON
 
Label History
 
View the label approved on February 21, 2007 for ACTIQ, (NDA) 020747


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
2/7/2007 027Patient Population Altered Letter
Label 
9/6/2006 023Labeling Revision Letter
Label 
9/9/2005 019Formulation Revision Letter
Label 
1/19/2005 018Labeling Revision Letter 
9/24/2004 017Labeling Revision Letter
Label 
6/10/2002 011Labeling Revision Letter 
3/12/2002 010Labeling Revision Letter 
1/29/2003 009Labeling Revision Letter 
2/19/2003 008Manufacturing Change or Addition Letter 
4/9/2001 006Control Supplement Letter 
8/25/2000 004Control Supplement  
3/26/1999 003Labeling Revision  
3/26/1999 002Labeling Revision  
11/4/1998 000Approval Letter
Label
Review
Medication Guide 
 
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