Visitor Monitoring Drug History: PHENERGAN
 
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Label and Approval History

Drug Name: PHENERGAN
FDA Application No: (NDA) 007935
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WYETH PHARMS INC
 
Label History
 
View the label approved on November 15, 2004 for PHENERGAN, (NDA) 007935


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/8/2004 030Labeling Revision Letter
Label 
12/26/2002 028Labeling Revision Letter 
12/26/2002 026Labeling Revision Letter 
12/26/2002 025Labeling Revision Letter 
3/30/1992 024Manufacturing Change or Addition  
6/30/1988 022Control Supplement  
11/21/1989 021Package Change  
4/7/1988 020Labeling Revision  
1/22/1988 019Labeling Revision  
5/31/1988 018Manufacturing Change or Addition  
12/11/1989 016Package Change  
3/19/1987 014Control Supplement  
5/29/1986 012Control Supplement  
3/29/1951 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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