← FDA DRUG APPROVALS

FDA NDA · NDA022405

CAPRELSA

vandetanib

Sponsor: GENZYME CORP

APPLICATION
NDA022405
TYPE
NDA
ORIGINAL APPROVAL
2011-04-06
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CAPRELSA · ReferencePrescription
VANDETANIB 100MG · TABLET · ORAL
CAPRELSA · ReferencePrescription
VANDETANIB 300MG · TABLET · ORAL

Approval history

2026-01-27Labeling · Supplement 26 · standard — Letter ↗AP
2025-09-23REMS · Supplement 25 — Letter ↗AP
2025-06-26REMS · Supplement 24 — Letter ↗AP
2025-05-14Labeling · Supplement 23 · standard — Label ↗AP
2024-03-07Efficacy · Supplement 22 · standard — Letter ↗AP
2023-04-13REMS · Supplement 21 — Letter ↗AP
2022-03-28Labeling · Supplement 19 · standard — Letter ↗AP
2020-06-15Labeling · Supplement 17 · standard — Label ↗AP
2020-06-05Labeling · Supplement 16 · standard — Label ↗AP
2018-10-12Efficacy · Supplement 14 · standard — Label ↗AP
2017-05-16REMS · Supplement 9 — Letter ↗AP
2017-02-24Labeling · Supplement 11 · standardAP
2016-07-28Labeling · Supplement 10 · standard — Letter ↗AP
2014-03-31Labeling · Supplement 7 · standard — Label ↗AP
2013-11-27Labeling · Supplement 5 · standard — Letter ↗AP
2013-07-03Labeling · Supplement 4 · standard — Label ↗AP
2012-10-09Labeling · Supplement 3 · standard — Label ↗AP
2011-06-22Labeling · Supplement 1 · unknown — Label ↗AP
2011-04-06Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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