Visitor Monitoring Drug History: DEMEROL
 
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Label and Approval History

Drug Name: DEMEROL
FDA Application No: (NDA) 005010
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for DEMEROL, (NDA) 005010
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/15/2003 048Labeling Revision Letter 
2/26/2003 047Labeling Revision Letter 
10/17/2000 046Control Supplement  
10/10/1995 045Control Supplement  
3/16/1995 044Package Change  
3/16/1995 043Control Supplement  
3/16/1995 042Package Change  
9/10/1992 041Control Supplement  
9/29/1992 040Control Supplement  
9/29/1992 039Control Supplement  
7/30/1992 038Package Change  
2/12/1991 037Manufacturing Change or Addition  
9/12/1990 036Manufacturing Change or Addition  
1/25/1990 035Manufacturing Change or Addition  
5/24/1989 034Manufacturing Change or Addition  
5/25/1989 033Manufacturing Change or Addition  
4/3/1989 032Package Change  
7/24/1997 031Labeling Revision  
1/6/1988 030Labeling Revision  
7/18/1986 029Labeling Revision  
5/12/1986 028Control Supplement  
6/4/1985 027Control Supplement  
5/20/1985 026Manufacturing Change or Addition  
5/20/1985 025Control Supplement  
1/17/1984 024Control Supplement  
3/28/1983 023Control Supplement  
3/28/1983 022Labeling Revision  
3/28/1983 021Control Supplement  
3/28/1983 020Control Supplement  
3/28/1983 019Package Change  
3/28/1983 018Package Change  
9/7/1982 017Control Supplement  
7/26/1979 014Labeling Revision  
7/21/1978 013Labeling Revision  
7/27/1978 012Labeling Revision  
12/2/1977 011Control Supplement  
1/4/1978 010Manufacturing Change or Addition  
8/10/1976 009Formulation Revision  
5/4/1976 008Labeling Revision  
1/18/1974 004Labeling Revision  
11/10/1942 000Approval  
 
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