Visitor Monitoring Drug History: NARCAN
 
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Label and Approval History

Drug Name: NARCAN
FDA Application No: (NDA) 016636
Active Ingredient(s): NALOXONE HYDROCHLORIDE
Company: ENDO PHARMS
 
Label History
 
Labels are not available on this site for NARCAN, (NDA) 016636
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/25/2002 057Control Supplement  
1/15/2002 056Control Supplement  
4/16/2002 055Manufacturing Change or Addition  
2/11/2002 054Labeling Revision Letter 
9/6/1996 053Control Supplement  
2/11/2002 052Labeling Revision Letter 
3/20/1995 051Control Supplement  
6/15/1995 050Control Supplement  
12/7/1987 049Control Supplement  
10/20/1987 048Control Supplement  
2/26/1987 047Control Supplement  
6/4/1986 046Final Printed Labeling - MarkIV  
6/4/1986 043Control Supplement  
6/4/1986 042Control Supplement  
6/4/1986 041Control Supplement  
9/17/1984 039Formulation Revision  
9/17/1984 038Formulation Revision  
9/25/1984 036Manufacturing Change or Addition  
10/15/1984 035Control Supplement  
7/23/1985 034Labeling Revision  
11/17/1983 033Manufacturing Change or Addition  
11/17/1983 032Manufacturing Change or Addition  
5/29/1992 031New or Modified Indication  
6/23/1983 030Package Change  
6/14/1982 028Package Change  
7/23/1982 027Labeling Revision  
5/19/1982 026Package Change  
5/14/1981 024Package Change  
5/14/1981 023Manufacturing Change or Addition  
9/30/1981 022Labeling Revision  
4/1/1981 021Manufacturing Change or Addition  
6/23/1981 020Manufacturing Change or Addition  
6/17/1980 019Manufacturing Change or Addition  
11/30/1979 018Manufacturing Change or Addition  
3/23/1979 017Labeling Revision  
10/20/1978 016Control Supplement  
4/6/1976 015Labeling Revision  
4/8/1976 014Labeling Revision  
9/24/1975 013Labeling Revision  
6/6/1975 011Labeling Revision  
12/9/1974 009Distributor  
6/5/1975 008Labeling Revision  
1/16/1975 007Labeling Revision  
4/4/1975 005Control Supplement  
4/4/1975 004Control Supplement  
4/13/1971 000Approval  
 
Therapeutic Equivalents
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