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) 008370
Active Ingredient(s):
DICYCLOMINE HYDROCHLORIDE
Company:
AXCAN SCANDIPHARM
Label History
View the
label approved on February 21, 2007
for BENTYL, (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 Date
Supplement Number
Approval Type
Letters, Reviews, Labels, Patient Package Insert
2/2/2007
031
Labeling Revision
Letter
Label
8/12/2002
030
Labeling Revision
Letter
6/23/2000
029
Package Change
8/17/1999
028
Labeling Revision
9/6/1996
027
Labeling Revision
12/23/1991
026
Labeling Revision
3/18/1991
025
Control Supplement
9/25/1990
024
Labeling Revision
1/4/1993
023
Manufacturing Change or Addition
2/18/1988
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
018
Control Supplement
10/15/1984
017
Labeling Revision
8/4/1989
013
Practioner Draft Labeling
8/13/1952
000
Approval
Therapeutic Equivalents
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