Visitor Monitoring Drug History: RESTORIL
 
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Label and Approval History

Drug Name: RESTORIL
FDA Application No: (NDA) 018163
Active Ingredient(s): TEMAZEPAM
Company: TYCO HLTHCARE
 
Label History
 
Labels are not available on this site for RESTORIL, (NDA) 018163
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/2/2004 057Manufacturing Change or Addition Letter 
5/31/2002 053Labeling Revision Letter 
10/27/1999 052Manufacturing Change or Addition  
4/15/1999 051Package Change  
12/7/1995 050Manufacturing Change or Addition  
12/18/1995 049Control Supplement  
4/11/2000 048Labeling Revision  
12/13/1994 047Control Supplement  
2/27/1995 046Control Supplement  
6/15/1993 045Package Change  
2/2/1993 044Labeling Revision  
7/15/1994 043Control Supplement  
11/25/1992 042Labeling Revision  
7/23/1993 041Package Change  
8/10/1992 040Labeling Revision  
7/13/1994 039Package Change  
7/13/1994 038Package Change  
4/16/1992 037Labeling Revision  
4/15/1992 036Control Supplement  
3/17/1994 035Control Supplement  
4/21/1993 034Package Change  
4/11/2000 032Labeling Revision  
3/29/1994 031Labeling Revision  
2/28/1994 030Control Supplement  
7/19/1994 029Labeling Revision  
3/14/1990 028Control Supplement  
2/16/1990 027Package Change  
6/28/1989 026Manufacturing Change or Addition  
1/22/1990 025Labeling Revision  
2/16/1990 024Package Change  
1/22/1990 023Labeling Revision  
10/25/1991 022New or Modified Indication  
9/2/1987 021Package Change  
4/10/1987 020Labeling Revision  
4/9/1987 019Manufacturing Change or Addition  
4/22/1986 018Package Change  
5/16/1986 017Control Supplement  
7/22/1985 015Manufacturing Change or Addition  
8/22/1985 014Control Supplement  
12/11/1984 013Package Change  
10/25/1991 011New or Modified Indication  
10/25/1982 007Manufacturing Change or Addition  
3/25/1982 005Package Change  
6/26/1981 003Manufacturing Change or Addition  
5/12/1981 002Formulation Revision  
5/12/1981 001Package Change  
2/27/1981 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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