Visitor Monitoring Drug History: REFLUDAN
 
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: REFLUDAN
FDA Application No: (NDA) 020807
Active Ingredient(s): LEPIRUDIN RECOMBINANT
Company: BAYER HLTHC
 
Label History
 
View the label approved on November 9, 2006 for REFLUDAN, (NDA) 020807


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
3/9/2007 015Labeling Revision Letter 
11/7/2006 011Labeling Revision Letter
Label 
4/2/2003 005Labeling Revision Letter 
4/1/1999 003Manufacturing Change or Addition  
3/4/1999 002Labeling Revision  
11/17/1998 001Control Supplement  
3/6/1998 000Approval Letter
Review
Consumer Information Sheet
Other 
 
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