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 21925

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

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.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-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