Visitor Monitoring Drug History: HYPAQUE-CYSTO
 
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Label and Approval History

Drug Name: HYPAQUE-CYSTO
FDA Application No: (NDA) 016403
Active Ingredient(s): DIATRIZOATE MEGLUMINE
Company: GE HEALTHCARE
 
Label History
 
Labels are not available on this site for HYPAQUECYSTO, (NDA) 016403
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/30/2002 071Labeling Revision Letter 
8/13/2001 070Control Supplement  
8/20/1998 069Manufacturing Change or Addition  
6/15/1995 068Labeling Revision  
3/25/1994 067Manufacturing Change or Addition  
10/3/1991 066Labeling Revision  
10/3/1991 065Labeling Revision  
10/3/1991 064Labeling Revision  
4/24/1991 063Control Supplement  
10/26/1989 062Control Supplement  
6/28/1989 061Labeling Revision  
5/26/1989 060Labeling Revision  
5/19/1989 059Labeling Revision  
4/18/1989 058Package Change  
6/22/1989 057Manufacturing Change or Addition  
6/22/1989 056Manufacturing Change or Addition  
4/11/1989 055Manufacturing Change or Addition  
2/22/1988 054Labeling Revision  
2/26/1990 053Manufacturing Change or Addition  
2/10/1986 052Labeling Revision  
11/22/1985 051Labeling Revision  
4/16/1985 050Labeling Revision  
4/23/1985 049Labeling Revision  
4/19/1985 048Labeling Revision  
11/26/1984 047Labeling Revision  
5/23/1988 046Package Change  
1/25/1983 045Expiration Date Change  
1/14/1985 044Package Change  
10/18/1982 043Manufacturing Change or Addition  
3/12/1984 042Practioner Draft Labeling  
9/11/1985 041Package Change  
2/28/1983 040Control Supplement  
3/18/1982 039Package Change  
3/12/1984 038Practioner Draft Labeling  
1/24/1984 037General Efficacy (MarkIV)  
2/24/1982 036Package Change  
1/16/1984 035Practioner Draft Labeling  
1/18/1982 034Control Supplement  
10/4/1983 033Expiration Date Change  
4/11/1981 032Manufacturing Change or Addition  
4/27/1981 031Expiration Date Change  
4/17/1979 030Package Change  
2/15/1979 029Package Change  
2/15/1979 028Control Supplement  
2/15/1979 027Manufacturing Change or Addition  
1/30/1978 026Manufacturing Change or Addition  
1/30/1978 025Manufacturing Change or Addition  
1/30/1978 024Manufacturing Change or Addition  
7/28/1978 023General Efficacy (MarkIV)  
4/1/1977 022Labeling Revision  
6/2/1976 021Manufacturing Change or Addition  
6/2/1976 020Manufacturing Change or Addition  
6/2/1976 019Manufacturing Change or Addition  
6/25/1976 018Labeling Revision  
6/21/1976 017Labeling Revision  
8/22/1975 012Labeling Revision  
5/29/1975 011Control Supplement  
5/29/1975 010Control Supplement  
5/29/1975 009Control Supplement  
8/21/1969 000Approval  
 
Therapeutic Equivalents
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