Visitor Monitoring Drug History: VALIUM
 
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Label and Approval History

Drug Name: VALIUM
FDA Application No: (NDA) 016087
Active Ingredient(s): DIAZEPAM
Company: ROCHE
 
Label History
 
Labels are not available on this site for VALIUM, (NDA) 016087
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/4/1998 084Control Supplement  
9/17/1997 083Control Supplement  
11/5/1997 082Manufacturing Change or Addition  
2/7/2002 081Labeling Revision Letter 
5/25/1993 080Control Supplement  
2/7/2002 079Labeling Revision Letter 
4/23/1987 078Control Supplement  
10/27/1987 077Control Supplement  
10/29/1986 076Control Supplement  
6/16/1986 074Control Supplement  
6/16/1986 072Package Change  
1/15/1986 071Package Change  
8/6/1985 070Manufacturing Change or Addition  
6/27/1985 069Labeling Revision  
5/31/1985 068Manufacturing Change or Addition  
6/26/1985 067Control Supplement  
6/26/1985 066Control Supplement  
4/18/1983 063Package Change  
3/29/1983 062Control Supplement  
3/14/1983 061Labeling Revision  
3/14/1983 060Labeling Revision  
3/14/1983 059Labeling Revision  
4/6/1983 058Labeling Revision  
3/1/1983 057Manufacturing Change or Addition  
10/29/1982 056Control Supplement  
8/20/1982 054Control Supplement  
10/27/1982 053Manufacturing Change or Addition  
5/18/1982 052Control Supplement  
8/5/1982 051Labeling Revision  
11/19/1981 050Package Change  
11/12/1981 049Labeling Revision  
11/13/1981 048Labeling Revision  
8/24/1981 047Package Change  
4/16/1981 046Control Supplement  
3/26/1981 045Labeling Revision  
4/16/1981 044Manufacturing Change or Addition  
4/20/1981 043Manufacturing Change or Addition  
5/19/1980 042Labeling Revision  
7/20/1979 041Labeling Revision  
11/2/1979 040Labeling Revision  
5/31/1979 039Labeling Revision  
4/9/1979 038Manufacturing Change or Addition  
3/23/1979 037Labeling Revision  
3/15/1980 036Control Supplement  
10/24/1978 035Control Supplement  
10/18/1977 033Package Change  
7/23/1976 030Formulation Revision  
4/23/1976 029Package Change  
11/13/1975 028Control Supplement  
5/1/1975 027Control Supplement  
12/2/1974 026Control Supplement  
11/15/1974 025Control Supplement  
6/5/1974 023Labeling Revision  
6/20/1974 022Labeling Revision  
8/24/1966 000Approval  
 
Therapeutic Equivalents
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