Visitor Monitoring Drug History: ACETAMINOPHEN W/ CODEINE NO. 3
 
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Label and Approval History

Drug Name: ACETAMINOPHEN W/ CODEINE NO. 3
FDA Application No: (ANDA) 084656
Active Ingredient(s): ACETAMINOPHEN; CODEINE PHOSPHATE
Company: ROXANE
 
Label History
 
Labels are not available on this site for ACETAMINOPHEN W CODEINE NO. 3, (ANDA) 084656
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/28/2000 050Control Supplement  
8/28/1996 049Chemistry  
3/15/1995 048Labeling  
9/28/1994 047Labeling  
12/16/1993 046Labeling  
10/3/1990 043Labeling  
12/5/1989 042Labeling  
1/3/1989 040Chemistry  
12/30/1988 039SBA  
1/3/1989 039Chemistry  
3/1/1989 037Labeling  
4/6/1984 035Chemistry  
5/10/1976 000Approval  
 
There are no Therapeutic Equivalents
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