Visitor Monitoring Drug History: ULTRAM
 
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: ULTRAM
FDA Application No: (NDA) 020281
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
Company: ORTHO MCNEIL PHARM
 
Label History
 
View the label approved on May 3, 2004 for ULTRAM, (NDA) 020281


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
4/16/2004 030Labeling Revision Letter
Label 
8/15/2001 029Labeling Revision Label 
2/13/2001 028Manufacturing Change or Addition  
6/2/2000 026Manufacturing Change or Addition  
4/10/2000 025Manufacturing Change or Addition  
3/8/2000 021Package Change  
3/21/2000 020Manufacturing Change or Addition  
8/20/1999 017Package Change  
12/23/1999 016New Dosage Regimen Letter
Label 
8/21/1998 015Labeling Revision Letter
Review 
8/21/1998 014New or Modified Indication Letter
Review 
11/20/1997 013Labeling Revision  
11/20/1997 012Labeling Revision  
10/30/1996 010Manufacturing Change or Addition  
11/27/1996 009Manufacturing Change or Addition  
3/20/1996 008Labeling Revision  
3/20/1996 007Labeling Revision  
3/20/1996 006Labeling Revision  
3/20/1996 005Labeling Revision  
3/20/1996 004Labeling Revision  
12/22/1995 003Manufacturing Change or Addition  
12/22/1995 002Package Change  
10/20/1995 001Manufacturing Change or Addition  
3/3/1995 000Approval  
 
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