← FDA DRUG APPROVALS

FDA NDA · NDA208462

NINLARO

ixazomib

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA208462
TYPE
NDA
ORIGINAL APPROVAL
2015-11-20
LATEST ACTION
2024-07-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NINLARO · ReferencePrescription
IXAZOMIB CITRATE EQ 2.3MG BASE · CAPSULE · ORAL
NINLARO · ReferencePrescription
IXAZOMIB CITRATE EQ 3MG BASE · CAPSULE · ORAL
NINLARO · ReferencePrescription
IXAZOMIB CITRATE EQ 4MG BASE · CAPSULE · ORAL

Approval history

2024-07-01Labeling · Supplement 17 · standard — Letter ↗AP
2024-03-01Labeling · Supplement 16 · standard — Label ↗AP
2022-04-28Efficacy · Supplement 12 · standard — Label ↗AP
2022-04-28Labeling · Supplement 13 · standard — Label ↗AP
2021-03-10Labeling · Supplement 10 · standard — Letter ↗AP
2020-09-10Labeling · Supplement 7 · standard — Letter ↗AP
2020-09-10Labeling · Supplement 8 · standard — Letter ↗AP
2020-02-21Labeling · Supplement 6 · standard — Letter ↗AP
2016-11-23Labeling · Supplement 1 · standard — Letter ↗AP
2015-11-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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