Visitor Monitoring Drug History: PHENERGAN FORTIS
 
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Label and Approval History

Drug Name: PHENERGAN FORTIS
FDA Application No: (NDA) 008381
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: ANI PHARMS
 
Label History
 
Labels are not available on this site for PHENERGAN FORTIS, (NDA) 008381
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/27/2003 027Labeling Revision Letter 
6/27/2003 026Supplement Letter 
5/6/1998 024Manufacturing Change or Addition  
3/30/1992 023Manufacturing Change or Addition  
2/6/1992 022Control Supplement  
12/12/1989 021Manufacturing Change or Addition  
12/13/1989 020Manufacturing Change or Addition  
6/30/1988 019Control Supplement  
4/6/1988 018Labeling Revision  
3/2/1987 014Labeling Revision  
9/8/1986 013Labeling Revision  
11/4/1985 012Labeling Revision  
7/27/1985 011Control Supplement  
5/29/1986 010Control Supplement  
4/18/1984 009New or Modified Indication  
4/18/1984 008Formulation Revision  
4/18/1984 007Practioner Draft Labeling  
4/11/1952 000Approval  
 
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