Visitor Monitoring Drug History: ACETAMINOPHEN W/ CODEINE
 
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Label and Approval History

Drug Name: ACETAMINOPHEN W/ CODEINE
FDA Application No: (ANDA) 086366
Active Ingredient(s): ACETAMINOPHEN; CODEINE PHOSPHATE
Company: ROXANE
 
Label History
 
Labels are not available on this site for ACETAMINOPHEN W CODEINE, (ANDA) 086366
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/12/1999 032Chemistry  
2/16/1999 030Chemistry  
9/9/1996 029Chemistry  
9/9/1996 028Chemistry  
8/28/1996 027Chemistry  
9/9/1996 026Labeling  
9/9/1996 025Chemistry  
3/15/1995 024Labeling  
9/28/1994 023Labeling  
12/16/1993 022Labeling  
10/3/1990 021Labeling  
2/13/1991 020Chemistry  
2/13/1991 019Chemistry  
10/3/1990 018Labeling  
7/13/1989 016Labeling  
5/13/1988 015Chemistry  
5/13/1988 014Chemistry  
7/8/1987 010Chemistry  
7/8/1987 009Chemistry  
4/10/1984 007Chemistry  
3/27/1979 000Approval  
 
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