Visitor Monitoring Drug History: OMNIPAQUE 240
 
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Label and Approval History

Drug Name: OMNIPAQUE 240
FDA Application No: (NDA) 018956
Active Ingredient(s): IOHEXOL
Company: GE HEALTHCARE
 
Label History
 
Labels are not available on this site for OMNIPAQUE 240, (NDA) 018956
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/1/2007 076Labeling Revision Letter 
3/25/2005 065Manufacturing Change or Addition Letter 
12/27/2004 062Labeling Revision Letter 
3/5/2004 058Labeling Revision Letter 
11/20/2002 054Manufacturing Change or Addition  
8/5/2002 053Manufacturing Change or Addition  
12/19/2000 052Control Supplement  
9/8/1998 051Control Supplement  
12/23/2002 049Labeling Revision Letter 
8/18/1995 046Manufacturing Change or Addition  
11/4/1994 045Manufacturing Change or Addition  
8/18/1995 044Control Supplement  
6/15/1995 043Labeling Revision Review 
11/28/1995 042Control Supplement  
9/30/1994 041Package Change  
10/20/1992 040Control Supplement  
12/23/2002 039Labeling Revision Letter 
9/30/1992 038Manufacturing Change or Addition  
12/11/1992 037Package Change  
6/1/1994 036Labeling Revision  
6/1/1994 035Package Change  
3/1/1993 034Package Change  
3/1/1993 033Labeling Revision  
3/1/1993 032Control Supplement  
3/1/1993 031Manufacturing Change or Addition  
12/4/1995 030Control Supplement  
8/24/1990 029Package Change  
7/13/1993 028New Route of Administration Review 
3/26/1992 027Control Supplement  
11/30/1989 026Patient Population Altered  
5/3/1989 024Labeling Revision  
7/28/1989 023New or Modified Indication  
7/28/1989 022Patient Population Altered  
6/30/1989 021New or Modified Indication  
6/30/1989 020New or Modified Indication  
1/4/1989 019Control Supplement  
3/31/1989 018New or Modified Indication  
11/30/1988 017New or Modified Indication  
4/18/1988 016Manufacturing Change or Addition  
5/24/1988 015New or Modified Indication  
7/29/1988 014New or Modified Indication  
1/27/1988 013Control Supplement  
2/1/1988 012Patient Population Altered  
5/22/1989 010Manufacturing Change or Addition  
5/12/1987 009New or Modified Indication  
12/23/1993 008Manufacturing Change or Addition  
6/4/1987 007Package Change  
5/27/1987 006Labeling Revision  
4/21/1987 004Labeling Revision  
11/20/1986 003Labeling Revision  
2/5/1987 002Manufacturing Change or Addition  
11/26/1986 001New or Modified Indication  
12/26/1985 000Approval  
 
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