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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021842
Company: TAKEDA PHARMS USA

Medication Guide

Other Important Information from FDA

Products on NDA 021842

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021842

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
12/21/2017	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021842Orig1s022ltr.pdf
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

Labels for NDA 021842

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf
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

Therapeutic Equivalents for NDA 021842

ACTOPLUS MET

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	091155	TEVA PHARMS USA

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