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CABOMETYX (CABOZANTINIB)

EXELIXIS INC

Summary

FDA approved CABOMETYX (CABOZANTINIB) by EXELIXIS INC. NDA (New Drug) approval (Labeling) on 2025-10-09. TABLET, ORAL.

Details

Source

Drug Approval

External ID

NDA208692-19

Action Date

2025-10-09

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

CABOMETYX (generic: CABOZANTINIB), TABLET, ORAL. Application: NDA208692

Context & Analysis

Frequently Asked Questions

How often does EXELIXIS INC have FDA actions?

This is the only FDA action we have on record for EXELIXIS INC in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA208692-19" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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