Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022024
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTOPLUS MET XR METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 1GM;EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ACTOPLUS MET XR METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 1GM;EQ 30MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/12/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022024s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022024_actoplus_met_xr_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022024s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf
12/12/2016 SUPPL-12 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf
03/16/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/17/2012 SUPPL-9 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf
08/04/2011 SUPPL-8 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/04/2011 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
12/22/2010 SUPPL-2 Labeling-Medication Guide, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022024s002ltr.pdf
11/12/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022024Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022024s013lbl.pdf
11/12/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf
08/04/2011 SUPPL-8 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf
08/04/2011 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf
08/04/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf
12/22/2010 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf
12/22/2010 SUPPL-2 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf
05/12/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf

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