Visitor Monitoring Drug History: HALCION
 
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Label and Approval History

Drug Name: HALCION
FDA Application No: (NDA) 017892
Active Ingredient(s): TRIAZOLAM
Company: PHARMACIA AND UPJOHN
 
Label History
 
Labels are not available on this site for HALCION, (NDA) 017892
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/4/1999 035Package Change  
6/25/2003 034Labeling Revision Letter
Review 
4/4/1996 033Labeling Revision  
11/4/1994 032Control Supplement  
7/13/1994 031Manufacturing Change or Addition  
9/14/1993 030Labeling Revision  
5/25/1993 026Control Supplement  
2/21/1992 024Package Change  
11/13/1991 023Labeling Revision  
1/17/1991 022Labeling Revision  
5/21/1993 021Control Supplement  
8/16/1990 019Labeling Revision  
8/16/1990 018Labeling Revision  
8/16/1990 017Labeling Revision  
3/20/1989 016Labeling Revision  
5/6/1988 015Labeling Revision  
5/5/1988 014Labeling Revision  
7/26/1988 013Manufacturing Change or Addition  
3/25/1988 012Package Change  
10/23/1987 011Labeling Revision  
10/23/1987 010Labeling Revision  
8/24/1988 009Control Supplement  
10/23/1987 008Labeling Revision  
10/23/1987 007Labeling Revision  
12/6/1985 005Manufacturing Change or Addition  
4/26/1985 004Labeling Revision  
10/23/1987 002Labeling Revision  
4/26/1985 001Formulation Revision  
11/15/1982 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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