Visitor Monitoring Drug History: DARVOCET-N 50
 
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Label and Approval History

Drug Name: DARVOCET-N 50
FDA Application No: (NDA) 017122
Active Ingredient(s): ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Company: XANODYNE PHARM
 
Label History
 
Labels are not available on this site for DARVOCETN 50, (NDA) 017122
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/24/1999 053Manufacturing Change or Addition  
10/5/1998 052Manufacturing Change or Addition  
8/10/1998 051Control Supplement  
4/2/1998 050Package Change  
5/15/1997 048Control Supplement  
10/30/2001 047Labeling Revision  
10/30/2001 046Labeling Revision  
3/14/1995 045Formulation Revision  
4/5/1994 044Manufacturing Change or Addition  
9/2/1994 043Labeling Revision  
9/15/1992 042Control Supplement  
12/17/1993 041Control Supplement  
8/23/1994 040Labeling Revision  
3/20/1995 039Labeling Revision  
4/16/1987 034Control Supplement  
10/17/1986 030Labeling Revision  
4/21/1986 029Labeling Revision  
4/3/1986 028Labeling Revision  
8/16/1984 025Control Supplement  
8/7/1984 024Labeling Revision  
10/28/1981 023Labeling Revision  
5/20/1981 022Labeling Revision  
4/16/1980 021Labeling Revision  
9/26/1979 020Labeling Revision  
11/6/1979 019Manufacturing Change or Addition  
7/17/1979 018Labeling Revision  
6/29/1979 016Formulation Revision  
10/16/1978 015Package Change  
1/21/1980 014Control Supplement  
5/6/1977 013Package Change  
5/6/1977 012Package Change  
6/10/1977 011Labeling Revision  
9/15/1976 009Expiration Date Change  
6/18/1974 005Control Supplement  
12/19/1972 000Approval  
 
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