Visitor Monitoring Drug History: ORAGRAFIN SODIUM
 
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Label and Approval History

Drug Name: ORAGRAFIN SODIUM
FDA Application No: (NDA) 012967
Active Ingredient(s): IPODATE SODIUM
Company: BRACCO
 
Label History
 
Labels are not available on this site for ORAGRAFIN SODIUM, (NDA) 012967
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/17/1992 036Manufacturing Change or Addition  
4/13/1988 035Labeling Revision  
9/25/1986 033Package Change  
10/25/1985 032Package Change  
3/29/1985 031Manufacturing Change or Addition  
6/30/1982 029Package Change  
2/10/1982 026Manufacturing Change or Addition  
1/18/1980 025Package Change  
1/18/1980 024Manufacturing Change or Addition  
9/13/1979 023Labeling Revision  
4/17/1979 022Control Supplement  
10/20/1978 021Control Supplement  
10/25/1978 020Control Supplement  
5/23/1978 018Labeling Revision  
6/7/1978 017Control Supplement  
11/1/1977 016Expiration Date Change  
6/7/1978 015Control Supplement  
5/11/1976 014Labeling Revision  
12/19/1975 013Control Supplement  
12/30/1975 012Labeling Revision  
12/19/1975 011Control Supplement  
12/30/1975 009Final Printed Labeling - MarkIV  
6/25/1962 000Approval  
 
Therapeutic Equivalents
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