Visitor Monitoring Drug History: BENTYL PRESERVATIVE FREE
 
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 PRESERVATIVE FREE
FDA Application No: (NDA) 008370
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
Company: AXCAN SCANDIPHARM
 
Label History
 
View the label approved on February 21, 2007 for BENTYL PRESERVATIVE FREE, (NDA) 008370


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 031Labeling Revision Letter
Label 
8/12/2002 030Labeling Revision Letter 
6/23/2000 029Package Change  
8/17/1999 028Labeling Revision  
9/6/1996 027Labeling Revision  
12/23/1991 026Labeling Revision  
3/18/1991 025Control Supplement  
9/25/1990 024Labeling Revision  
1/4/1993 023Manufacturing Change or Addition  
2/18/1988 022Manufacturing Change or Addition  
2/6/1987 021Labeling Revision  
6/12/1985 020Control Supplement  
5/13/1985 019Labeling Revision  
10/15/1984 018Control Supplement  
10/15/1984 017Labeling Revision  
8/4/1989 013Practioner Draft Labeling  
8/13/1952 000Approval  
 
Therapeutic Equivalents
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