Visitor Monitoring Drug History: SALUTENSIN-DEMI
 
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Label and Approval History

Drug Name: SALUTENSIN-DEMI
FDA Application No: (NDA) 012359
Active Ingredient(s): HYDROFLUMETHIAZIDE; RESERPINE
Company: SHIRE
 
Label History
 
Labels are not available on this site for SALUTENSINDEMI, (NDA) 012359
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/24/1996 032Manufacturing Change or Addition  
10/7/1992 031Manufacturing Change or Addition  
7/9/1990 030Manufacturing Change or Addition  
6/22/1988 029Labeling Revision  
10/24/1986 028Control Supplement  
6/27/1986 027Manufacturing Change or Addition  
8/1/1985 026Control Supplement  
7/29/1985 025Labeling Revision  
6/8/1984 024Package Change  
8/23/1983 023Labeling Revision  
5/10/1984 022Formulation Revision  
3/3/1982 021Control Supplement  
3/3/1982 020Package Change  
8/3/1981 019Labeling Revision  
7/29/1985 018Practioner Draft Labeling  
6/10/1982 017Package Change  
7/31/1979 016Labeling Revision  
10/3/1980 015Control Supplement  
10/3/1980 014Control Supplement  
5/15/1978 013Final Printed Labeling - MarkIV  
5/15/1978 012Package Change  
4/27/1978 011Control Supplement  
5/15/1978 010Control Supplement  
5/15/1978 009Formulation Revision  
6/23/1977 006Labeling Revision  
12/13/1977 005Other Amendment  
6/23/1977 003Formulation Revision  
6/20/1960 000Approval  
 
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