Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 084176
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: SANDOZ
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 084176
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/16/2002 054Control Supplement  
4/19/2002 053Control Supplement  
11/20/2002 052Package Change  
3/23/2001 051Control Supplement  
5/5/1999 050Chemistry  
12/15/1998 049Chemistry  
10/3/1996 048Chemistry  
12/1/1995 047Chemistry  
3/17/1995 046Chemistry  
8/28/1991 045Labeling in Effect  
11/1/1988 044Labeling  
1/3/1986 043Chemistry  
2/7/1985 041Chemistry  
12/13/1983 040Chemistry  
12/13/1983 039Chemistry  
11/2/1983 038Chemistry  
2/1/1983 037Chemistry  
6/23/1982 036Chemistry  
3/23/1982 035Chemistry  
5/1/1981 031Chemistry  
5/12/1982 030Chemistry  
5/12/1982 028Chemistry  
6/23/1982 027Chemistry  
5/12/1982 017Chemistry  
5/12/1982 016Chemistry  
2/18/1975 000Approval  
 
Therapeutic Equivalents
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