Visitor Monitoring Drug History: TEMOVATE
 
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Label and Approval History

Drug Name: TEMOVATE
FDA Application No: (NDA) 019323
Active Ingredient(s): CLOBETASOL PROPIONATE
Company: ALTANA
 
Label History
 
View the label approved on April 7, 2003 for TEMOVATE, (NDA) 019323


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/2/2003 019Labeling Revision Letter
Label 
6/1/1998 017Manufacturing Change or Addition  
11/15/1996 016Manufacturing Change or Addition Review 
6/29/1994 015Control Supplement  
6/7/1994 014Manufacturing Change or Addition  
8/23/1993 013Control Supplement  
3/5/1993 012Control Supplement  
8/30/1995 011Labeling Revision  
4/17/1992 010Manufacturing Change or Addition  
12/7/1989 008Labeling Revision  
12/7/1989 007Labeling Revision  
8/13/1987 006Expiration Date Change  
12/7/1989 005Labeling Revision  
3/3/1987 004Package Change  
7/10/1987 003Control Supplement  
4/9/1987 002Control Supplement  
12/27/1985 000Approval  
 
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