← FDA DRUG APPROVALS

FDA NDA · NDA212725

ROZLYTREK

entrectinib

Sponsor: GENENTECH INC

APPLICATION
NDA212725
TYPE
NDA
ORIGINAL APPROVAL
2019-08-15
LATEST ACTION
2024-01-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ROZLYTREK · ReferencePrescription
ENTRECTINIB 200MG · CAPSULE · ORAL
ROZLYTREK · ReferencePrescription
ENTRECTINIB 100MG · CAPSULE · ORAL

Approval history

2024-01-26Labeling · Supplement 11 · standard — Label ↗AP
2023-10-20Efficacy · Supplement 9 · priority — Letter ↗AP
2023-08-31Labeling · Supplement 8 · standard — Letter ↗AP
2023-06-16Labeling · Supplement 7 · standard — Letter ↗AP
2022-07-18Labeling · Supplement 6 · standard — Letter ↗AP
2021-11-05Labeling · Supplement 5 · standard — Label ↗AP
2019-08-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →