Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (NDA) 040428
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: G AND W LABS
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (NDA) 040428
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/31/2003 004Labeling  
3/31/2003 002Chemistry New Strength  
11/20/2002 001Labeling  
2/5/2002 000Approval Review 
 
Therapeutic Equivalents
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