Visitor Monitoring Drug History: OLUX
 
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Label and Approval History

Drug Name: OLUX
FDA Application No: (NDA) 021142
Active Ingredient(s): CLOBETASOL PROPIONATE
Company: CONNETICS
 
Label History
 
View the label approved on January 2, 2004 for OLUX, (NDA) 021142


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
7/11/2006 012Labeling Revision Letter 
12/29/2003 010Control Supplement Letter
Label 
10/31/2003 009Labeling Revision Letter
Label 
7/21/2003 007Manufacturing Change or Addition Letter 
9/17/2002 006Control Supplement  
8/21/2002 005Manufacturing Change or Addition  
12/20/2002 004New or Modified Indication Letter
Label 
3/13/2002 003Package Change Letter 
11/29/2001 002Control Supplement  
9/14/2000 001Control Supplement  
5/26/2000 000Approval Letter
Label
Review 
 
Therapeutic Equivalents
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