Visitor Monitoring Drug History: OMNISCAN
 
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: OMNISCAN
FDA Application No: (NDA) 020123
Active Ingredient(s): GADODIAMIDE
Company: GE HEALTHCARE
 
Label History
 
View the label approved on September 6, 2007 for OMNISCAN, (NDA) 020123


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
9/5/2007 034Labeling Revision Letter
Label 
8/12/2002 024Control Supplement  
11/15/2002 023Manufacturing Change or Addition Letter 
6/28/2002 022Labeling Revision Letter 
5/20/2002 021Manufacturing Change or Addition Letter 
3/15/2002 020Manufacturing Change or Addition  
7/30/2001 019Control Supplement  
7/8/2002 018Labeling Revision Letter 
3/13/2001 017Manufacturing Change or Addition  
1/17/2001 016Expiration Date Change  
10/3/1997 015Labeling Revision Review 
3/19/1997 014Control Supplement  
3/27/1997 013Manufacturing Change or Addition  
2/17/1995 009Control Supplement  
2/5/1996 007New Dosage Regimen  
2/5/1996 005New or Modified Indication  
2/5/1996 004New Dosage Regimen  
6/6/1994 003Manufacturing Change or Addition  
11/4/1994 002Manufacturing Change or Addition  
4/26/1993 001Control Supplement  
1/8/1993 000Approval Other Important Information from FDA 
 
There are no Therapeutic Equivalents
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