Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 083426
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 083426
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/25/2001 040Control Supplement  
9/8/1998 038Chemistry  
1/28/1991 037Chemistry  
8/7/1991 036Chemistry  
6/29/1990 035Chemistry  
10/18/1989 034Labeling  
3/29/1989 033SBA  
12/13/1983 027Chemistry  
3/26/1997 020Chemistry  
9/19/1973 000Approval  
 
There are no Therapeutic Equivalents
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