Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 083711
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 083711
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/25/2001 038Control Supplement  
12/5/1997 036Chemistry  
12/16/1997 035Chemistry  
1/28/1991 034Chemistry  
8/7/1991 033Chemistry  
6/29/1990 032Chemistry  
3/29/1989 031SBA  
9/28/1989 031Labeling  
3/18/1988 027Labeling  
2/18/1986 024Chemistry  
2/18/1986 023Chemistry  
12/21/1983 022Chemistry  
9/21/1973 000Approval  
 
There are no Therapeutic Equivalents
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