Visitor Monitoring Drug History: XYLOCAINE
 
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Label and Approval History

Drug Name: XYLOCAINE
FDA Application No: (NDA) 008816
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
Company: ABRAXIS BIOSCIENCE
 
Label History
 
View the label approved on July 28, 2004 for XYLOCAINE, (NDA) 008816


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
7/23/2004 032Labeling Revision Letter
Label 
6/2/2000 031Package Change  
7/29/1999 030Package Change  
5/31/1996 029Manufacturing Change or Addition  
4/7/1998 028Package Change  
2/18/1993 027Manufacturing Change or Addition  
11/7/1990 024Package Change  
6/8/1987 017Package Change  
6/8/1987 016Control Supplement  
9/16/1987 015Manufacturing Change or Addition  
6/20/1984 014Manufacturing Change or Addition  
7/11/1984 013Labeling Revision  
7/11/1984 012Formulation Revision  
3/25/1982 009Control Supplement  
11/20/1984 008Practioner Draft Labeling  
2/23/1981 007Labeling Revision  
2/23/1981 006General Efficacy (MarkIV)  
2/16/1979 005Package Change  
2/2/1977 004Labeling Revision  
1/12/1977 003Control Supplement  
2/2/1977 002Labeling Revision  
3/6/1973 001Labeling Revision  
3/12/1953 000Approval  
 
Therapeutic Equivalents
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