DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
MOTRIN
FDA Application No:
(NDA) 019842
Active Ingredient(s):
IBUPROFEN
Company:
MCNEIL PED
Label History
View the
label approved on September 11, 2007
for MOTRIN, (NDA) 019842
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
9/10/2007
020
Labeling Revision
Letter
Label
1/24/2006
019
Labeling Revision
Letter
Label
5/14/2001
016
Control Supplement
7/18/2000
015
Control Supplement
2/4/2002
013
Labeling Revision
Review
2/22/1996
011
Control Supplement
2/7/1996
010
Control Supplement
6/23/1995
009
Control Supplement
6/23/1995
007
Control Supplement
6/23/1995
006
Control Supplement
6/13/1994
005
Control Supplement
3/24/1995
004
New or Modified Indication
3/23/1993
003
Labeling Revision
9/19/1989
000
Approval
Therapeutic Equivalents
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