Visitor Monitoring Drug History: FLOLAN
 
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: FLOLAN
FDA Application No: (NDA) 020444
Active Ingredient(s): EPOPROSTENOL SODIUM
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on April 14, 2000 for FLOLAN, (NDA) 020444


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
9/20/2002 010Manufacturing Change or Addition  
6/21/2002 009Manufacturing Change or Addition  
6/21/2002 008Package Change  
4/5/2002 007Manufacturing Change or Addition  
1/17/2002 006Manufacturing Change or Addition  
9/21/2000 005Labeling Revision  
11/2/1999 004Labeling Revision  
4/14/2000 003New or Modified Indication Letter
Label
Review 
11/21/1997 002Manufacturing Change or Addition  
3/18/1996 001Labeling Revision  
9/20/1995 000Approval  
 
There are no Therapeutic Equivalents
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