← FDA DRUG APPROVALS

FDA NDA · NDA203756

COMETRIQ

cabozantinib

Sponsor: EXELIXIS

APPLICATION
NDA203756
TYPE
NDA
ORIGINAL APPROVAL
2012-11-29
LATEST ACTION
2025-10-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

COMETRIQ · ReferencePrescription
CABOZANTINIB S-MALATE EQ 80MG BASE · CAPSULE · ORAL
COMETRIQ · ReferencePrescription
CABOZANTINIB S-MALATE EQ 20MG BASE · CAPSULE · ORAL

Approval history

2025-10-09Labeling · Supplement 13 · standard — Label ↗AP
2023-08-23Labeling · Supplement 11 · standard — Letter ↗AP
2020-10-22Labeling · Supplement 9 · standard — Letter ↗AP
2020-01-31Labeling · Supplement 8 · standard — Label ↗AP
2018-01-12Labeling · Supplement 5 · standard — Letter ↗AP
2017-10-05Labeling · Supplement 4 · standard — Label ↗AP
2016-05-20Efficacy · Supplement 2 · standard — Label ↗AP
2014-02-28Manufacturing (CMC) · Supplement 1 · priorityAP
2012-11-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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