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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021073
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription AB Yes No
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB Yes No
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf
12/12/2016 SUPPL-48 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf
11/12/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf
08/04/2011 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
08/04/2011 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
08/04/2011 SUPPL-43 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
02/03/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf
09/09/2009 SUPPL-37 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf
09/09/2009 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf
12/11/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf
09/06/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf
08/14/2007 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf
02/25/2007 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf
11/04/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf
08/30/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf
08/03/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf
07/20/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf
11/26/2003 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf
06/11/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf
07/12/2002 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf
07/15/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf
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