Visitor Monitoring Drug History: PHENERGAN
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: PHENERGAN
FDA Application No: (NDA) 011689
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WYETH PHARMS INC
 
Label History
 
View the label approved on November 15, 2004 for PHENERGAN, (NDA) 011689


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 024Labeling Revision Letter
Label 
9/12/2001 021Control Supplement  
12/26/2002 020Labeling Revision Letter 
12/26/2002 019Labeling Revision Letter 
12/26/2002 018Labeling Revision Letter 
8/1/2001 017Manufacturing Change or Addition  
12/26/2002 016Labeling Revision Letter 
7/1/1994 015Control Supplement  
3/30/1992 014Manufacturing Change or Addition  
4/28/1993 013Manufacturing Change or Addition  
6/30/1988 010Control Supplement  
1/22/1988 009Labeling Revision  
5/29/1986 006Control Supplement  
4/27/1960 000Approval  
 
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