Visitor Monitoring Drug History: SINEMET
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: SINEMET
FDA Application No: (NDA) 017555
Active Ingredient(s): CARBIDOPA; LEVODOPA
Company: BRISTOL MYERS SQUIBB
 
Label History
 
Labels are not available on this site for SINEMET, (NDA) 017555
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/5/2002 062Manufacturing Change or Addition  
10/11/2001 061Manufacturing Change or Addition  
3/16/2001 060Control Supplement  
2/1/2001 059Control Supplement  
2/1/2001 058Control Supplement  
3/16/2001 057Manufacturing Change or Addition  
4/11/2001 055Labeling Revision Letter 
6/6/2000 054Manufacturing Change or Addition  
4/4/2000 053Manufacturing Change or Addition  
4/11/2001 051Labeling Revision Letter 
4/11/2001 050Labeling Revision Letter 
11/26/1997 048Formulation Revision  
12/4/1997 047Formulation Revision  
11/7/1997 046Package Change  
4/11/2001 045Labeling Revision Letter 
5/16/1996 044Package Change  
7/13/1995 043Control Supplement  
4/11/2001 040Labeling Revision Letter 
4/11/2001 039Labeling (MarkIV) Letter 
4/11/2001 038Labeling Revision Letter 
4/11/2001 037Labeling Revision Letter 
4/11/2001 036Labeling Revision Letter 
4/21/1988 035Labeling Revision  
2/26/1988 034Control Supplement  
1/17/1986 033Labeling Revision  
1/17/1986 032Labeling Revision  
7/12/1985 031Package Change  
7/30/1985 030Labeling Revision  
5/6/1985 029Manufacturing Change or Addition  
3/2/1984 028Manufacturing Change or Addition  
5/11/1984 027Control Supplement  
9/13/1984 026Control Supplement  
1/17/1986 025Labeling Revision  
1/17/1986 024Labeling Revision  
1/17/1986 023Labeling Revision  
5/4/1983 022Control Supplement  
8/21/1981 020Formulation Revision  
6/9/1983 019Package Change  
9/2/1981 018Labeling Revision  
9/9/1980 016Labeling Revision  
1/12/1981 015Formulation Revision  
2/11/1980 014Package Change  
1/29/1980 012Labeling Revision  
1/29/1980 011Manufacturing Change or Addition  
3/12/1980 010Labeling Revision  
10/22/1979 009Package Change  
7/13/1978 008Control Supplement  
3/13/1980 007Formulation Revision  
3/24/1978 006Labeling Revision  
4/29/1977 005Labeling Revision  
1/25/1978 004Package Change  
1/26/1978 003Formulation Revision  
5/2/1975 000Approval  
 
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