Visitor Monitoring Drug History: CAPOTEN
 
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Label and Approval History

Drug Name: CAPOTEN
FDA Application No: (NDA) 018343
Active Ingredient(s): CAPTOPRIL
Company: PAR PHARM
 
Label History
 
Labels are not available on this site for CAPOTEN, (NDA) 018343
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/7/2004 075Labeling Revision Letter 
4/20/1999 073Labeling Revision  
1/9/1998 072Control Supplement  
8/21/1997 071Control Supplement  
6/25/1996 070Manufacturing Change or Addition  
3/1/1996 069Control Supplement  
7/31/1996 068Labeling Revision  
3/6/1995 067Control Supplement  
6/13/1995 066Formulation Revision  
11/4/1993 065Labeling Revision  
1/28/1994 064New or Modified Indication  
3/31/1994 063Labeling Revision  
5/12/1993 062Package Change  
6/25/1992 061Labeling Revision  
9/3/1992 060Labeling Revision  
12/21/1992 059Control Supplement  
1/14/1992 058Control Supplement  
6/19/1995 057Control Supplement  
5/7/1992 056Formulation Revision  
10/7/1991 055Manufacturing Change or Addition  
1/31/1991 054Package Change  
4/12/1991 053Manufacturing Change or Addition  
11/5/1990 052Package Change  
3/21/1991 051Labeling Revision  
9/27/1990 050Labeling Revision  
5/10/1990 049Manufacturing Change or Addition  
9/23/1993 048New or Modified Indication  
5/3/1989 047Labeling Revision  
10/19/1989 046Labeling Revision  
5/13/1988 045Control Supplement  
2/19/1988 044Labeling Revision  
6/26/1987 041Expiration Date Change  
5/13/1988 040New or Modified Indication  
1/6/1987 039Package Change  
1/21/1987 038Control Supplement  
2/13/1987 037Control Supplement  
4/2/1987 036Manufacturing Change or Addition  
8/14/1986 035Manufacturing Change or Addition  
7/24/1986 033Control Supplement  
3/23/1990 032Control Supplement  
3/4/1986 031Control Supplement  
9/17/1986 030Control Supplement  
5/27/1986 029Control Supplement  
2/27/1986 028Expiration Date Change  
1/17/1986 027Labeling Revision  
12/18/1985 026Package Change  
4/16/1985 025Control Supplement  
6/12/1985 024Manufacturing Change or Addition  
4/16/1985 023Control Supplement  
11/19/1984 022Control Supplement  
10/12/1984 021Labeling Revision  
7/12/1984 020Package Change  
1/17/1985 018General Efficacy (MarkIV)  
9/18/1984 017Control Supplement  
6/8/1984 016Package Change  
6/8/1984 015Package Change  
8/28/1984 014General Efficacy (MarkIV)  
10/14/1983 013Package Change  
2/7/1984 012Expiration Date Change  
10/14/1983 011Formulation Revision  
5/18/1983 010Control Supplement  
7/10/1985 009Labeling Revision  
2/7/1984 008Manufacturing Change or Addition  
3/9/1982 007Control Supplement  
2/25/1982 006Control Supplement  
10/25/1982 005General Efficacy (MarkIV)  
11/30/1981 004Formulation Revision  
10/27/1981 003Control Supplement  
10/7/1982 002Control Supplement  
6/12/1981 001Package Change  
4/6/1981 000Approval Other Important Information from FDA 
 
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