Visitor Monitoring Drug History: TESULOID
 
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Label and Approval History

Drug Name: TESULOID
FDA Application No: (NDA) 016923
Active Ingredient(s): TECHNETIUM TC-99M SULFUR COLLOID KIT
Company: BRACCO
 
Label History
 
Labels are not available on this site for TESULOID, (NDA) 016923
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/25/1991 020New or Modified Indication  
5/18/1988 018Package Change  
11/23/1985 017General Efficacy (MarkIV)  
9/30/1985 016Manufacturing Change or Addition  
8/19/1983 015Control Supplement  
3/23/1984 014Practioner Draft Labeling  
7/20/1981 013Control Supplement  
6/10/1982 012Labeling Revision  
8/2/1983 011Formulation Revision  
9/25/1980 010Labeling Revision  
4/30/1979 009Labeling Revision  
3/20/1978 007Labeling Revision  
1/31/1977 006Final Printed Labeling - MarkIV  
1/31/1977 005Labeling Revision  
7/15/1976 004Manufacturing Change or Addition  
5/10/1976 002Labeling Revision  
8/22/1975 001Labeling (MarkIV)  
6/10/1974 000Approval  
 
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