Visitor Monitoring Drug History: OXSORALEN
 
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Label and Approval History

Drug Name: OXSORALEN
FDA Application No: (NDA) 009048
Active Ingredient(s): METHOXSALEN
Company: VALEANT PHARM INTL
 
Label History
 
View the label approved on March 28, 2003 for OXSORALEN, (NDA) 009048


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
10/31/2001 040Control Supplement  
4/5/2000 038Control Supplement  
3/26/2003 037Labeling Revision Letter
Label 
4/7/1998 036Control Supplement  
3/16/1998 035Manufacturing Change or Addition  
9/23/1997 034Control Supplement  
9/23/1997 033Control Supplement  
1/25/1996 031Manufacturing Change or Addition  
3/23/1988 030New or Modified Indication  
4/16/1984 025Labeling Revision  
4/21/1983 022Labeling Revision  
5/7/1982 021Labeling Revision  
5/7/1982 020Labeling Revision  
4/4/1975 006Labeling Revision  
11/13/1974 005Supplement  
12/3/1954 000Approval  
 
There are no Therapeutic Equivalents
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