Visitor Monitoring Drug History: FLONASE
 
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: FLONASE
FDA Application No: (NDA) 020121
Active Ingredient(s): FLUTICASONE PROPIONATE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on April 5, 2004 for FLONASE, (NDA) 020121


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
3/26/2004 030Labeling Revision Letter
Label 
5/1/2003 028Efficacy Supplement with Clinical Data to Support Letter
Label 
5/7/2002 026Package Change  
3/4/2002 025Control Supplement  
2/19/2002 024Control Supplement  
5/23/2002 023New Dosage Regimen Letter 
7/9/2001 022Control Supplement  
6/25/2001 021Control Supplement  
5/9/2002 020Labeling Revision Letter 
8/3/2001 017Control Supplement  
6/20/2000 016Manufacturing Change or Addition  
5/17/2000 015Control Supplement  
5/9/2002 013Labeling Revision Letter 
2/18/2000 012Manufacturing Change or Addition  
5/9/2002 011Labeling Revision Letter 
10/1/1998 010Labeling Revision  
12/11/1998 009New or Modified Indication Letter
Label
Review 
9/26/2000 008Control Supplement  
2/18/1998 006Control Supplement  
10/31/1997 005New or Modified Indication  
12/12/1996 004Labeling Revision  
3/27/1996 003Labeling Revision  
8/1/1995 002Control Supplement  
10/19/1994 000Approval  
 
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