Visitor Monitoring Drug History: FLOMAX
 
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Label and Approval History

Drug Name: FLOMAX
FDA Application No: (NDA) 020579
Active Ingredient(s): TAMSULOSIN HYDROCHLORIDE
Company: BOEHRINGER INGELHEIM
 
Label History
 
View the label approved on February 21, 2007 for FLOMAX, (NDA) 020579


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
2/16/2007 021Labeling Revision Letter
Label 
1/11/2007 020Labeling Revision Letter
Label 
10/18/2005 016Labeling Revision Letter
Label 
12/17/2001 012Control Supplement  
8/20/2001 011Manufacturing Change or Addition  
6/6/2001 010Control Supplement  
7/26/2000 009Package Change  
6/30/2000 008Manufacturing Change or Addition  
5/1/2001 007Labeling Revision  
9/2/1999 006Manufacturing Change or Addition  
2/23/1999 005Control Supplement  
1/19/1999 004Manufacturing Change or Addition  
12/8/1998 003Control Supplement  
5/26/1998 002Labeling Revision  
8/25/1997 001Control Supplement  
4/15/1997 000Approval Review 
 
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