Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 080629
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 080629
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/20/2002 210Formulation Revision  
2/19/1999 208Microbiology  
2/2/1999 207Microbiology  
12/4/1996 206Microbiology  
5/6/1992 205Chemistry  
1/11/1991 204Labeling in Effect  
4/9/1990 203Labeling  
10/12/1989 202Labeling  
10/12/1989 201Labeling  
10/12/1989 201Labeling in Effect  
4/11/1989 200Chemistry  
4/11/1989 199Chemistry  
4/20/1989 198SBA  
2/28/1989 198Chemistry  
8/22/1988 197SBA  
2/28/1989 197Chemistry  
8/3/1988 196Chemistry  
8/3/1988 195Chemistry  
6/16/1986 191Chemistry  
11/3/1982 187Chemistry  
4/23/1982 184Chemistry  
4/23/1982 155Chemistry  
1/29/1974 000Approval  
 
Therapeutic Equivalents
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