Visitor Monitoring Drug History: SERAX
 
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Label and Approval History

Drug Name: SERAX
FDA Application No: (NDA) 015539
Active Ingredient(s): OXAZEPAM
Company: ALPHARMA US PHARMS
 
Label History
 
View the label approved on August 8, 2001 for SERAX, (NDA) 015539


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
11/30/2001 054Manufacturing Change or Addition  
4/5/2000 053Labeling Revision  
8/8/2001 052Labeling Revision Letter
Label 
1/21/1992 048Package Change  
11/8/1988 046Manufacturing Change or Addition  
2/1/1989 045Control Supplement  
11/17/1989 044Manufacturing Change or Addition  
7/21/1988 043Control Supplement  
6/14/1989 040Manufacturing Change or Addition  
4/7/1987 037Manufacturing Change or Addition  
2/2/1987 036Package Change  
9/8/1986 035Manufacturing Change or Addition  
7/16/1986 034Manufacturing Change or Addition  
2/2/1984 027Labeling Revision  
6/11/1986 021Formulation Revision  
11/22/1985 018Formulation Revision  
5/29/1980 017Labeling Revision  
12/3/1979 015Package Change  
1/24/1978 013Labeling Revision  
5/7/1975 009Control Supplement  
6/15/1976 008Control Supplement  
6/4/1965 000Approval  
 
Therapeutic Equivalents
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