Visitor Monitoring Drug History: FLEXERIL
 
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: FLEXERIL
FDA Application No: (NDA) 017821
Active Ingredient(s): CYCLOBENZAPRINE HYDROCHLORIDE
Company: MCNEIL PED
 
Label History
 
View the label approved on March 5, 2003 for FLEXERIL, (NDA) 017821


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/5/2002 047Manufacturing Change or Addition  
10/3/2002 046Manufacturing Change or Addition  
2/3/2003 045Efficacy Supplement with Clinical Data to Support Letter
Label 
9/15/1998 041Control Supplement  
11/29/1996 040Control Supplement  
3/1/1996 039Manufacturing Change or Addition  
8/18/1994 037Control Supplement  
1/10/1990 033Manufacturing Change or Addition  
6/9/1994 032Manufacturing Change or Addition  
4/8/1988 031Package Change  
5/30/1986 029Labeling Revision  
1/16/1986 026Labeling Revision  
2/24/1984 025Manufacturing Change or Addition  
6/21/1997 024Labeling Revision  
1/4/1983 023Package Change  
5/13/1982 021Control Supplement  
4/1/1982 020Manufacturing Change or Addition  
6/21/1983 019Package Change  
5/26/1981 018Package Change  
5/26/1981 017Manufacturing Change or Addition  
6/3/1982 016Labeling Revision  
12/2/1980 015Package Change  
10/10/1980 014Formulation Revision  
10/10/1980 013Manufacturing Change or Addition  
10/10/1980 012Labeling Revision  
8/21/1980 011Control Supplement  
5/31/1979 008Labeling Revision  
5/3/1979 007Manufacturing Change or Addition  
3/2/1978 004Labeling Revision  
3/14/1978 002Labeling Revision  
8/26/1977 000Approval  
 
Therapeutic Equivalents
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