Visitor Monitoring Drug History: SALURON
 
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Label and Approval History

Drug Name: SALURON
FDA Application No: (NDA) 011949
Active Ingredient(s): HYDROFLUMETHIAZIDE
Company: SHIRE
 
Label History
 
Labels are not available on this site for SALURON, (NDA) 011949
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/24/1996 025Manufacturing Change or Addition  
12/2/1988 024Labeling Revision  
7/28/1986 023Manufacturing Change or Addition  
3/27/1985 022Control Supplement  
6/8/1984 021Package Change  
1/9/1984 020Labeling Revision  
11/7/1983 019Package Change  
3/27/1985 018Formulation Revision  
11/7/1983 017Package Change  
11/7/1983 016Control Supplement  
7/29/1985 015Practioner Draft Labeling  
5/6/1980 014Labeling Revision  
11/14/1986 013Package Change  
12/13/1979 012Labeling Revision  
1/30/1981 011Control Supplement  
4/27/1978 010Control Supplement  
4/29/1977 009Labeling Revision  
7/22/1959 000Approval  
 
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