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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208462
Company: TAKEDA PHARMS USA

Summary Review

Products on NDA 208462

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NINLARO	IXAZOMIB CITRATE	EQ 2.3MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
NINLARO	IXAZOMIB CITRATE	EQ 3MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
NINLARO	IXAZOMIB CITRATE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208462

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208462Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208462Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208462s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208462Orig1s016ltr.pdf
04/28/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf
04/28/2022	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf
03/10/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208462s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208462Orig1s010ltr.pdf
09/10/2020	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s007, s008ltr.pdf
09/10/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s007, s008ltr.pdf
02/21/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208462Orig1s006ltr.pdf
11/23/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208462s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208462Orig1s001ltr.pdf

Labels for NDA 208462

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208462s016lbl.pdf
04/28/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf
04/28/2022	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf
03/10/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208462s010lbl.pdf
09/10/2020	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf
09/10/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf
02/21/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462s006lbl.pdf
11/23/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208462s001lbl.pdf
11/20/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf

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