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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022426
Company: TAKEDA PHARMS USA

Medication Guide

Original Letter

Products on NDA 022426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 25MG BASE;EQ 15MG BASE	TABLET;ORAL	Prescription	None	Yes	No
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 25MG BASE;EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	No
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 25MG BASE;EQ 45MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 12.5MG BASE;EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	No
OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2013	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000Ltr_1_.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022426Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022426s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022271Orig1s013; 022426Orig1s014; 203414Orig1s013ltr.pdf
07/01/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf
12/21/2017	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022426s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022426Orig1s010ltr.pdf
12/12/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf
12/12/2016	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf
08/28/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf
03/17/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/05/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf
08/15/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022426s014lbl.pdf
07/01/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf
12/21/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022426s010lbl.pdf
12/12/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf
04/05/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf
08/28/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf
01/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf

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