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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021925
Company: TAKEDA PHARMS USA

Medication Guide

Other Important Information from FDA

Products on NDA 021925

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	AB	Yes	Yes
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021925

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2006	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021925s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021925_duetact_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021925Orig1s017ltr.pdf
12/12/2016	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021925Orig1s016ltr.pdf
03/16/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021925Orig1s015ltr.pdf
11/12/2013	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf
07/22/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/17/2012	SUPPL-12	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-11	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/04/2011	SUPPL-10	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
09/23/2010	SUPPL-8	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021925s008ltr.pdf
09/09/2009	SUPPL-7	REMS-Proposal, Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s007ltr.pdf
11/12/2013	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf
01/04/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s005ltr.pdf
09/26/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s004ltr.pdf
10/01/2007	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s003ltr.pdf
09/06/2007	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s002ltr.pdf
02/06/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s001ltr.pdf

Labels for NDA 021925

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf
03/16/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf
11/12/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf
11/12/2013	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf
08/04/2011	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
08/04/2011	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
08/04/2011	SUPPL-10	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
09/23/2010	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf
01/04/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf
10/01/2007	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf
10/01/2007	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf
09/26/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf
09/06/2007	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf
09/06/2007	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf
02/06/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf
07/28/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf

Therapeutic Equivalents for NDA 021925

DUETACT

TABLET;ORAL; 2MG;30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	Yes	AB	021925	TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET;ORAL	Prescription	No	AB	201049	SANDOZ

TABLET;ORAL; 4MG;30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	Yes	AB	021925	TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET;ORAL	Prescription	No	AB	201049	SANDOZ

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