← FDA DRUG APPROVALS

FDA NDA · NDA208692

CABOMETYX

cabozantinib

Sponsor: EXELIXIS INC

APPLICATION
NDA208692
TYPE
NDA
ORIGINAL APPROVAL
2016-04-25
LATEST ACTION
2025-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CABOMETYX · ReferencePrescription
CABOZANTINIB S-MALATE EQ 60MG BASE · TABLET · ORAL
CABOMETYX · ReferencePrescription
CABOZANTINIB S-MALATE EQ 20MG BASE · TABLET · ORAL
CABOMETYX · ReferencePrescription
CABOZANTINIB S-MALATE EQ 40MG BASE · TABLET · ORAL

Approval history

2025-10-09Labeling · Supplement 19 · standard — Label ↗AP
2025-09-10Efficacy · Supplement 18 · standard — Letter ↗AP
2025-03-26Efficacy · Supplement 17 · standard — Label ↗AP
2023-09-20Labeling · Supplement 16 · standard — Letter ↗AP
2023-02-13Labeling · Supplement 13 · standard — Letter ↗AP
2022-07-14Efficacy · Supplement 14 · standard — Letter ↗AP
2021-09-17Efficacy · Supplement 12 · priority — Label ↗AP
2021-01-22Efficacy · Supplement 10 · priority — Label ↗AP
2020-11-05Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2020-07-16Labeling · Supplement 8 · standard — Label ↗AP
2020-01-31Labeling · Supplement 7 · standard — Label ↗AP
2019-01-14Efficacy · Supplement 3 · standard — Label ↗AP
2017-12-19Efficacy · Supplement 2 · priority — Label ↗AP
2017-11-16Labeling · Supplement 1 · standard — Letter ↗AP
2016-04-25Type 3 - New Dosage Form · 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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