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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022271
Company: TAKEDA PHARMS USA

Medication Guide

Summary Review

Products on NDA 022271

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NESINA	ALOGLIPTIN BENZOATE	EQ 6.25MG BASE	TABLET;ORAL	Prescription	None	Yes	No
NESINA	ALOGLIPTIN BENZOATE	EQ 12.5MG BASE	TABLET;ORAL	Prescription	None	Yes	No
NESINA	ALOGLIPTIN BENZOATE	EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022271

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 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022271Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2023	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022271Orig1s015;203414Orig1s016ltr.pdf
03/11/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.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/2019/022271s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf
12/12/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s011ltr.pdf
05/27/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s009ltr.pdf
04/19/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/28/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf
07/20/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/05/2016	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf
08/15/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/26/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/30/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022271

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2023	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf
03/11/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.pdf
07/01/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf
12/12/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf
05/27/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf
04/05/2016	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf
08/28/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf
01/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf

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