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FDA NDA · NDA215310

EXKIVITY

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA215310
TYPE
NDA
ORIGINAL APPROVAL
2021-09-15
LATEST ACTION
2023-09-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

EXKIVITY · ReferenceDiscontinued
MOBOCERTINIB SUCCINATE EQ 40MG BASE · CAPSULE · ORAL

Approval history

2023-09-15Labeling · Supplement 3 · standard — Letter ↗AP
2023-03-02Labeling · Supplement 2 · standard — Letter ↗AP
2021-09-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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