FDA NDA · NDA208434

ALECENSA

alectinib hydrochloride

Sponsor: HOFFMANN-LA ROCHE

APPLICATION

NDA208434

TYPE

NDA

ORIGINAL APPROVAL

2015-12-11

LATEST ACTION

2026-06-11

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

ALECENSA · ReferencePrescription

ALECTINIB HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL

2026-06-11Efficacy · Supplement 16 · standard — Letter ↗AP

2024-04-18Efficacy · Supplement 15 · priority — Letter ↗AP

2021-09-03Labeling · Supplement 12 · standard — Letter ↗AP

2021-01-29Labeling · Supplement 10 · standard — Label ↗AP

2018-06-05Labeling · Supplement 4 · standard — Label ↗AP

2017-11-06Efficacy · Supplement 3 · priority — Label ↗AP

2016-11-04Labeling · Supplement 1 · standard — Letter ↗AP

2015-12-11Type 1 - New Molecular Entity · Original · priority — Review ↗AP

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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