DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
BENTYL
FDA Application No:
(NDA) 007961
Active Ingredient(s):
DICYCLOMINE HYDROCHLORIDE
Company:
AXCAN SCANDIPHARM
Label History
View the
label approved on February 21, 2007
for BENTYL, (NDA) 007961
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 Date
Supplement Number
Approval Type
Letters, Reviews, Labels, Patient Package Insert
2/2/2007
026
Labeling Revision
Letter
Label
8/17/1999
025
Labeling Revision
9/9/1996
024
Labeling Revision
9/25/1990
023
Labeling Revision
1/4/1993
022
Manufacturing Change or Addition
2/6/1987
021
Labeling Revision
6/12/1985
020
Control Supplement
5/13/1985
019
Labeling Revision
10/15/1984
017
Control Supplement
10/15/1984
016
Labeling Revision
8/4/1989
011
Practioner Draft Labeling
4/30/1951
000
Approval
Therapeutic Equivalents
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