Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (NDA) 040712
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: KVK-TECH INC
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (NDA) 040712
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/4/2007 006Chemistry New Strength  
5/4/2007 005Chemistry New Strength  
5/4/2007 004Chemistry New Strength  
5/4/2007 003Chemistry New Strength  
5/4/2007 002Chemistry New Strength  
5/4/2007 001Chemistry New Strength  
7/31/2006 000Approval Letter 
 
Therapeutic Equivalents
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