Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021842
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription AB Yes No
ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription AB 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
08/29/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021842ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021842s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2016 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf
12/12/2016 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf
08/16/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021842Orig1s019ltr.pdf
08/15/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/17/2012 SUPPL-16 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-15 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/04/2011 SUPPL-14 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/06/2010 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021842s012ltr.pdf
10/21/2009 SUPPL-11 REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s011ltr.pdf
05/17/2012 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf
09/14/2009 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s009ltr.pdf
05/17/2012 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf
01/04/2009 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s007ltr.pdf
09/26/2007 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021842s005ltr.pdf
09/28/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf
11/04/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf
08/30/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021842s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf
12/12/2016 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf
08/16/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf
05/17/2012 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf
05/17/2012 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf
08/04/2011 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf
08/04/2011 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf
08/04/2011 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf
10/21/2009 SUPPL-11 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf
01/04/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf
09/26/2007 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf
11/04/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf
08/30/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf
08/29/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf

ACTOPLUS MET

TABLET;ORAL; 500MG;EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription Yes AB 021842 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 200823 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 204802 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 090406 MYLAN
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 091273 SANDOZ
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 091155 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 202001 TORRENT PHARMS LTD

TABLET;ORAL; 850MG;EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription Yes AB 021842 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 200823 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 204802 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 090406 MYLAN
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 091273 SANDOZ
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 091155 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 202001 TORRENT PHARMS LTD

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