Visitor Monitoring Drug History: BENTYL
 
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: BENTYL
FDA Application No: (NDA) 007409
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
Company: AXCAN SCANDIPHARM
 
Label History
 
View the label approved on February 21, 2007 for BENTYL, (NDA) 007409


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
2/2/2007 040Labeling Revision Letter
Label 
8/17/1999 039Labeling Revision  
9/9/1996 038Labeling Revision  
10/29/1991 036Package Change  
6/24/1992 035Formulation Revision  
9/25/1990 034Labeling Revision  
1/4/1993 033Manufacturing Change or Addition  
6/15/1989 032Manufacturing Change or Addition  
3/15/1990 031Package Change  
2/6/1987 029Labeling Revision  
6/12/1985 028Control Supplement  
5/13/1985 027Labeling Revision  
10/15/1984 025Control Supplement  
10/15/1984 024Labeling Revision  
8/4/1989 016Practioner Draft Labeling  
5/11/1950 000Approval  
 
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