Visitor Monitoring Drug History: RENOGRAFIN-76
 
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Label and Approval History

Drug Name: RENOGRAFIN-76
FDA Application No: (NDA) 010040
Active Ingredient(s): DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Company: BRACCO
 
Label History
 
Labels are not available on this site for RENOGRAFIN76, (NDA) 010040
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/23/2002 168Labeling Revision Letter 
6/29/2000 167Manufacturing Change or Addition  
9/9/1994 166Labeling Revision  
9/25/2003 163Practioner Draft Labeling Letter 
7/7/1989 162Labeling Revision  
6/8/1987 160Control Supplement  
11/25/1985 159Labeling Revision  
7/23/1985 158Labeling Revision  
7/23/1985 157Labeling Revision  
6/6/1985 156Labeling Revision  
6/5/1985 155Labeling Revision  
6/6/1985 154Labeling Revision  
7/23/1985 153Labeling Revision  
7/23/1985 152Labeling Revision  
6/6/1985 151Labeling Revision  
7/23/1985 150Labeling Revision  
6/12/1985 149Labeling Revision  
6/12/1985 148Labeling Revision  
6/6/1985 147Labeling Revision  
6/12/1985 146Labeling Revision  
1/28/1985 145Manufacturing Change or Addition  
5/23/1985 144Manufacturing Change or Addition  
4/3/1984 143General Efficacy (MarkIV)  
5/23/1985 142Manufacturing Change or Addition  
2/2/1983 140Labeling Revision  
1/6/1984 139Package Change  
1/14/1985 138Control Supplement  
11/9/1982 137Control Supplement  
2/24/1982 135Control Supplement  
3/5/1991 134Formulation Revision  
3/31/1982 122Labeling Revision  
9/27/1982 121General Efficacy (MarkIV)  
7/1/1981 120Control Supplement  
8/1/1980 118Final Printed Labeling - MarkIV  
6/4/1980 117Labeling Revision  
7/1/1980 116Labeling Revision  
6/20/1980 115Labeling Revision  
4/14/1980 114Labeling Revision  
6/4/1980 113Labeling Revision  
6/30/1982 111Labeling Revision  
3/14/1980 110Labeling Revision  
1/26/1983 109Labeling Revision  
8/3/1979 108Control Supplement  
7/10/1983 107General Efficacy (MarkIV)  
6/30/1982 105Labeling Revision  
6/30/1980 103Labeling Revision  
6/8/1979 102Labeling Revision  
6/8/1979 101Labeling Revision  
6/8/1979 100Labeling Revision  
1/24/1980 099Control Supplement  
10/12/1979 098Labeling Revision  
10/12/1979 097Labeling Revision  
9/13/1979 096Labeling Revision  
3/19/1980 095Labeling Revision  
9/13/1979 094Labeling Revision  
6/26/1979 093Labeling Revision  
2/16/1979 092Control Supplement  
12/28/1978 091Formulation Revision  
2/23/1978 089Control Supplement  
9/15/1978 088Control Supplement  
3/14/1978 087Labeling Revision  
11/1/1977 086Labeling Revision  
10/21/1977 085Labeling Revision  
3/30/1979 083Control Supplement  
1/11/1977 082Labeling (MarkIV)  
1/11/1977 081Control Supplement  
1/11/1977 080Package Change  
12/6/1976 079Labeling Revision  
8/22/1977 078Labeling Revision  
12/14/1976 077Package Change  
12/2/1976 076Labeling Revision  
1/31/1978 075Labeling Revision  
9/13/1976 074Labeling Revision  
9/10/1976 073Labeling Revision  
9/10/1976 072Labeling Revision  
9/6/1976 071Labeling Revision  
9/13/1976 070Labeling Revision  
9/13/1976 069Labeling Revision  
9/9/1976 068Labeling Revision  
9/10/1976 067Labeling Revision  
5/26/1976 066Control Supplement  
6/16/1976 065Labeling Revision  
5/6/1976 064Expiration Date Change  
5/6/1976 063Labeling Revision  
5/5/1976 062Labeling Revision  
5/5/1976 061Labeling Revision  
5/5/1976 059Expiration Date Change  
5/6/1976 058Labeling Revision  
5/6/1976 057Labeling Revision  
9/24/1975 056Control Supplement  
9/30/1975 055Labeling Revision  
9/30/1975 054Labeling Revision  
5/27/1975 053Other Amendment  
6/17/1977 033Control Supplement  
8/2/1955 000Approval  
 
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