FDA NDA · NDA212725

ROZLYTREK

Sponsor: GENENTECH INC

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APPLICATION
NDA212725
TYPE
NDA
ORIGINAL APPROVAL
2019-08-15
LATEST ACTION
2026-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2026-10-01Labeling · Supplement 14 · standard — Letter ↗AP
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 ↗

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