DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
OPANA
FDA Application No:
(NDA) 011707
Active Ingredient(s):
OXYMORPHONE HYDROCHLORIDE
Company:
ENDO PHARMS
Label History
View the
label approved on October 18, 2006
for OPANA, (NDA) 011707
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
10/16/2006
031
Labeling Revision
Letter
Label
10/25/2002
029
Control Supplement
1/15/2002
028
Control Supplement
4/16/2002
027
Manufacturing Change or Addition
10/29/1997
026
Labeling Revision
8/6/1997
025
Control Supplement
9/25/2000
024
Control Supplement
10/15/1996
023
Labeling Revision
8/11/1994
022
Package Change
5/11/1994
021
Control Supplement
12/8/1987
020
Control Supplement
8/24/1993
017
Control Supplement
8/31/1983
016
Manufacturing Change or Addition
8/31/1983
015
Manufacturing Change or Addition
11/9/1981
013
Manufacturing Change or Addition
4/1/1981
011
Manufacturing Change or Addition
3/26/1976
008
Labeling Revision
4/2/1959
000
Approval
There are no Therapeutic Equivalents
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