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Label and Approval History
Drug Name(s) ACTOS (Brand Name Drug)
FDA Application No. (NDA) 021073
Active Ingredient(s) PIOGLITAZONE HYDROCHLORIDE
Company TAKEDA PHARMS NA
Go to Approval History
Label Information

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

    View the label approved on 09/09/2009  PDF file: requires free Adobe Acrobat Reader for ACTOS, NDA no. 021073

  • 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
NDA 021073

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
09/09/2009 037 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
12/11/2008 034 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
05/07/2008 033 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader
Patient Package Insert  PDF file: requires free Adobe Acrobat Reader 		Label is not available
on this site. 
09/06/2007 030 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
08/14/2007 031 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
02/25/2007 026 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
11/04/2006 028 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
09/28/2006 029 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
08/30/2006 027 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
08/03/2004 023 SupplementLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
07/20/2004 024 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
11/26/2003 020 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
06/11/2003 021 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
01/21/2003 017 Efficacy Supplement with Clinical Data to SupportLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
12/03/2002 018 Package ChangeLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
10/01/2002 013 Control SupplementReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
07/12/2002 010 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
02/28/2002 015 Control SupplementReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
01/07/2002 016 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		Label is not available
on this site. 
08/03/2001 014 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
07/06/2001 008 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
07/06/2001 009 Manufacturing Change or Addition This supplement type does
not usually require new labeling. 
07/02/2001 011 Labeling Revision Label is not available
on this site. 
05/22/2001 012 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
04/25/2001 007 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
11/03/2000 006 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
10/25/2000 004 Control SupplementReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
07/26/2000 005 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
04/11/2000 003 Manufacturing Change or AdditionReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
02/25/2000 001 Package ChangeReview  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
02/25/2000 002 Control SupplementReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
07/15/1999 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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