Visitor Monitoring Drug History: HYPAQUE
 
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Label and Approval History

Drug Name: HYPAQUE
FDA Application No: (NDA) 009561
Active Ingredient(s): DIATRIZOATE SODIUM
Company: GE HEALTHCARE
 
Label History
 
Labels are not available on this site for HYPAQUE, (NDA) 009561
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/13/2001 079Control Supplement  
8/20/1998 078Manufacturing Change or Addition  
6/15/1995 077Labeling Revision  
8/23/1996 076Control Supplement  
10/5/1993 075Manufacturing Change or Addition  
10/3/1991 073Labeling Revision  
10/3/1991 072Labeling Revision  
10/3/1991 071Labeling Revision  
6/29/1989 070Labeling Revision  
5/26/1989 069Labeling Revision  
5/2/1989 068Labeling Revision  
4/11/1989 067Manufacturing Change or Addition  
2/22/1988 066Labeling Revision  
8/24/1987 064Labeling Revision  
11/7/1986 063Labeling Revision  
2/26/1990 062Manufacturing Change or Addition  
6/25/1986 061Labeling Revision  
3/17/1986 060Labeling Revision  
8/14/1986 059Manufacturing Change or Addition  
6/26/1985 058Labeling Revision  
4/19/1985 057Labeling Revision  
5/23/1988 056Package Change  
3/23/1987 055Expiration Date Change  
1/14/1985 053Package Change  
10/18/1982 052Manufacturing Change or Addition  
8/3/1983 050Control Supplement  
3/18/1982 049Package Change  
2/1/1987 048Practioner Draft Labeling  
2/24/1982 047Labeling Revision  
4/5/1984 046Practioner Draft Labeling  
2/29/1984 045Practioner Draft Labeling  
1/18/1982 043Control Supplement  
8/6/1986 042Formulation Revision  
4/11/1981 041Manufacturing Change or Addition  
6/30/1982 040Labeling Revision  
10/11/1979 039Package Change  
1/22/1979 038Package Change  
2/15/1979 037Control Supplement  
2/1/1978 036Control Supplement  
1/31/1978 035Manufacturing Change or Addition  
12/16/1977 034Manufacturing Change or Addition  
10/6/1978 033Labeling Revision  
2/23/1977 031Labeling Revision  
9/8/1976 030Manufacturing Change or Addition  
5/26/1976 027Manufacturing Change or Addition  
6/2/1976 026Manufacturing Change or Addition  
9/8/1976 025Manufacturing Change or Addition  
5/26/1976 024Labeling Revision  
6/2/1976 023Labeling Revision  
2/11/1976 022Final Printed Labeling - MarkIV  
11/26/1954 000Approval  
 
Therapeutic Equivalents
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