Visitor Monitoring Drug History: ULTANE
 
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Label and Approval History

Drug Name: ULTANE
FDA Application No: (NDA) 020478
Active Ingredient(s): SEVOFLURANE
Company: ABBOTT
 
Label History
 
View the label approved on June 28, 2006 for ULTANE, (NDA) 020478


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
6/27/2006 016Labeling Revision Letter
Label 
6/21/2005 013Labeling Revision Letter
Label 
6/27/2003 012Labeling Revision Letter 
5/24/2002 011Manufacturing Change or Addition  
8/9/2001 010Labeling Revision  
9/28/2001 009Control Supplement  
3/14/2001 008Control Supplement  
12/11/2002 007Labeling Revision Letter
Review 
3/30/2001 006Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
6/16/2000 004Package Change  
8/6/1998 003Labeling Revision  
12/23/1997 002Labeling Revision  
7/2/1997 001Package Change  
6/7/1995 000Approval  
 
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