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COMETRIQ (CABOZANTINIB)

EXELIXIS

Summary

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

Details

Source

Drug Approval

External ID

NDA203756-13

Action Date

2025-10-09

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

COMETRIQ (generic: CABOZANTINIB), CAPSULE, ORAL. Application: NDA203756

Company

Context & Analysis

Frequently Asked Questions

How often does EXELIXIS have FDA actions?

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

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA203756-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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