Visitor Monitoring Drug History: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
 
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Label and Approval History

Drug Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
FDA Application No: (NDA) 016964
Active Ingredient(s): BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Company: HOSPIRA
 
Label History
 
View the label approved on November 1, 2005 for MARCAINE HYDROCHLORIDE W EPINEPHRINE, (NDA) 016964


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
10/30/2005 061Labeling Revision Letter
Label 
1/31/2001 053Control Supplement  
3/11/1999 052Labeling Revision  
3/11/1999 051Labeling Revision  
4/9/1997 050Manufacturing Change or Addition  
3/11/1999 048Labeling Revision  
1/25/1993 047Control Supplement  
3/11/1999 046Labeling Revision  
8/8/1991 045Labeling Revision  
2/6/1991 044Package Change  
2/6/1991 043Control Supplement  
4/27/1988 042Package Change  
7/13/1987 041Labeling Revision  
9/15/1987 040Control Supplement  
1/27/1987 039Labeling Revision  
1/27/1987 038Package Change  
8/24/1985 037Labeling Revision  
8/19/1985 036Labeling Revision  
9/11/1985 035Labeling Revision  
12/1/1983 034Labeling Revision  
5/20/1985 031Package Change  
1/21/1983 030Control Supplement  
7/13/1983 029Labeling Revision  
7/13/1983 028Control Supplement  
3/2/1984 025Expiration Date Change  
11/21/1983 024Practioner Draft Labeling  
12/28/1981 023Labeling Revision  
8/21/1981 022Labeling Revision  
8/21/1981 021Control Supplement  
1/27/1982 020Control Supplement  
11/3/1980 019Labeling Revision  
12/6/1979 018Control Supplement  
6/18/1979 017Labeling Revision  
4/4/1979 016Control Supplement  
8/21/1980 015Labeling Revision  
8/21/1980 014Control Supplement  
4/4/1979 013Control Supplement  
6/15/1978 012Control Supplement  
6/15/1978 011Control Supplement  
7/7/1976 008Manufacturing Change or Addition  
11/30/1976 007Final Printed Labeling - MarkIV  
6/10/1976 006Control Supplement  
6/7/1976 005Control Supplement  
6/10/1976 004Labeling Revision  
1/13/1976 003Labeling Revision  
10/3/1972 000Approval  
 
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