Visitor Monitoring Drug History: GABITRIL
 
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Label and Approval History

Drug Name: GABITRIL
FDA Application No: (NDA) 020646
Active Ingredient(s): TIAGABINE HYDROCHLORIDE
Company: CEPHALON
 
Label History
 
View the label approved on December 5, 2005 for GABITRIL, (NDA) 020646


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
11/29/2005 015Manufacturing Change or Addition Letter
Label 
2/14/2005 014Labeling Revision Letter
Label 
10/3/2001 011Manufacturing Change or Addition  
10/3/2001 010Package Change  
7/27/2001 009Manufacturing Change or Addition  
5/16/2000 008Manufacturing Change or Addition  
5/17/2000 007Control Supplement  
8/23/1999 006Expiration Date Change  
4/16/1999 005Labeling Revision  
4/16/1999 004Manufacturing Change or Addition  
7/31/1998 003Control Supplement  
5/8/1998 002Package Change  
10/9/1997 001Control Supplement  
9/30/1997 000Approval Other Important Information from FDA
Patient Information Sheet
Healthcare Professional Sheet 
 
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