Visitor Monitoring Drug History: XYLOCAINE W/ EPINEPHRINE
 
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Label and Approval History

Drug Name: XYLOCAINE W/ EPINEPHRINE
FDA Application No: (NDA) 006488
Active Ingredient(s): EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Company: ABRAXIS BIOSCIENCE
 
Label History
 
Labels are not available on this site for XYLOCAINE W EPINEPHRINE, (NDA) 006488
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/17/2002 066Control Supplement  
12/8/2000 065Control Supplement  
12/14/2000 064Control Supplement  
3/6/1998 062Manufacturing Change or Addition  
5/26/1999 061Labeling Revision  
5/2/1996 060Control Supplement  
5/31/1996 059Manufacturing Change or Addition  
1/3/1996 058Manufacturing Change or Addition  
12/8/1997 057Package Change  
7/18/1995 056Expiration Date Change  
7/11/1995 055Control Supplement  
11/21/1994 054Manufacturing Change or Addition  
4/13/1993 053Control Supplement  
2/18/1993 052Manufacturing Change or Addition  
10/20/1993 051Expiration Date Change  
10/2/1990 050Control Supplement  
7/11/1989 049Package Change  
12/2/1988 048Labeling Revision  
12/2/1988 047Package Change  
9/11/1987 046Labeling Revision  
9/11/1987 045Control Supplement  
3/18/1987 044Labeling Revision  
9/16/1987 043Manufacturing Change or Addition  
5/19/1986 042Labeling Revision  
2/27/1986 041Labeling Revision  
8/29/1986 040Labeling Revision  
8/29/1986 039Control Supplement  
11/13/1986 038Labeling Revision  
11/13/1986 037Control Supplement  
3/21/1991 036Labeling Revision  
3/21/1991 035Control Supplement  
3/22/1985 034Labeling Revision  
3/22/1985 033Control Supplement  
12/3/1984 032Labeling Revision  
6/28/1982 031Manufacturing Change or Addition  
3/25/1982 030Control Supplement  
2/22/1986 029Labeling Revision  
2/22/1986 028Control Supplement  
12/12/1984 027Practioner Draft Labeling  
10/1/1981 026Labeling Revision  
7/26/1982 025Labeling Revision  
7/26/1982 024Control Supplement  
10/1/1981 023Control Supplement  
4/17/1980 022Control Supplement  
8/29/1979 021Labeling Revision  
12/31/1980 020Labeling Revision  
2/27/1979 019Control Supplement  
4/9/1979 018Labeling Revision  
4/9/1979 017Control Supplement  
3/26/1979 016Control Supplement  
5/17/1978 015Labeling Revision  
2/2/1976 013Manufacturing Change or Addition  
10/9/1975 011Labeling Revision  
7/16/1975 010Control Supplement  
8/28/1975 009Control Supplement  
8/28/1975 008Labeling Revision  
6/24/1974 006Supplement  
5/20/1974 005Control Supplement  
12/4/1972 002Labeling Revision  
11/19/1948 000Approval  
 
There are no Therapeutic Equivalents
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