Visitor Monitoring Drug History: BENADRYL
 
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Label and Approval History

Drug Name: BENADRYL
FDA Application No: (NDA) 005845
Active Ingredient(s): DIPHENHYDRAMINE HYDROCHLORIDE
Company: MCNEIL CONS
 
Label History
 
Labels are not available on this site for BENADRYL, (NDA) 005845
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/14/1987 044Manufacturing Change or Addition  
5/19/1986 043Labeling Revision  
5/19/1986 042Labeling Revision  
8/2/1985 041Labeling Revision  
8/2/1985 040Labeling Revision  
8/7/1985 039Manufacturing Change or Addition  
5/19/1986 038Labeling Revision  
5/19/1986 037Manufacturing Change or Addition  
8/30/1984 033Control Supplement  
8/30/1984 031General Efficacy (MarkIV)  
3/4/1946 000Approval  
 
Therapeutic Equivalents
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