Visitor Monitoring Drug History: TANDEARIL
 
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Label and Approval History

Drug Name: TANDEARIL
FDA Application No: (NDA) 012542
Active Ingredient(s): OXYPHENBUTAZONE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for TANDEARIL, (NDA) 012542
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/25/1985 056Labeling Revision  
8/13/1984 055Control Supplement  
2/25/1983 052Manufacturing Change or Addition  
9/14/1982 051Manufacturing Change or Addition  
7/25/1980 050Manufacturing Change or Addition  
9/6/1979 049Labeling Revision  
8/8/1979 048Manufacturing Change or Addition  
9/3/1982 047Control Supplement  
11/8/1978 046Control Supplement  
12/16/1977 045Labeling Revision  
12/16/1977 044Labeling Revision  
4/26/1979 043Package Change  
2/28/1978 042Labeling Revision  
2/9/1979 041Control Supplement  
4/26/1979 040Control Supplement  
11/29/1977 039Formulation Revision  
1/5/1978 037Labeling Revision  
4/29/1977 036Package Change  
12/21/1960 000Approval  
 
Therapeutic Equivalents
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