Visitor Monitoring Drug History: OPANA
 
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: 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 DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/16/2006 031Labeling Revision Letter
Label 
10/25/2002 029Control Supplement  
1/15/2002 028Control Supplement  
4/16/2002 027Manufacturing Change or Addition  
10/29/1997 026Labeling Revision  
8/6/1997 025Control Supplement  
9/25/2000 024Control Supplement  
10/15/1996 023Labeling Revision  
8/11/1994 022Package Change  
5/11/1994 021Control Supplement  
12/8/1987 020Control Supplement  
8/24/1993 017Control Supplement  
8/31/1983 016Manufacturing Change or Addition  
8/31/1983 015Manufacturing Change or Addition  
11/9/1981 013Manufacturing Change or Addition  
4/1/1981 011Manufacturing Change or Addition  
3/26/1976 008Labeling Revision  
4/2/1959 000Approval  
 
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