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Label and Approval History
Drug Name(s) VIREAD (Brand Name Drug)
FDA Application No. (NDA) 021356
Active Ingredient(s) TENOFOVIR DISOPROXIL FUMARATE
Company GILEAD
Go to Approval History
Label Information

What information does a label include?
Note: Not all labels are available in electronic format from FDA.

    The latest approved label (approved 01/15/2010) is not available on this site for VIREAD, NDA no. 021356

    View the label approved on 11/10/2009  PDF file: requires free Adobe Acrobat Reader   

  • To see if other previously-approved labels are available on this site, 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
NDA 021356

Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.

Click on a column header to re-sort the table:

Action
Date
Supplement
Number
Approval
Type 		Letters,
Reviews,
Labels,
Patient Package Insert  		 Note
01/15/2010 032 Manufacturing Change or Addition This supplement type does
not usually require new labeling. 
11/10/2009 028 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/07/2009 027 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
11/04/2008 026 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
08/11/2008 025 New or Modified IndicationLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
05/16/2008 024 Efficacy Supplement with Clinical Data to SupportLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
05/21/2007 021 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
03/07/2006 016 Accelerated ApprovalLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
11/30/2005 017 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
05/12/2005 011 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
07/01/2004 010 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/31/2003 006 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/14/2003 005 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
08/15/2003 003 Patient Population AlteredLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
12/02/2002 001 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/26/2001 000 ApprovalLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review 		 

PDF files, marked with an icon PDF file: requires free Adobe Acrobat Reader, require the free Adobe Acrobat Reader.

  • There are no Therapeutic Equivalents

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