← FDA DRUG APPROVALS

FDA NDA · NDA206192

COTELLIC

cobimetinib

Sponsor: GENENTECH INC

APPLICATION
NDA206192
TYPE
NDA
ORIGINAL APPROVAL
2015-11-10
LATEST ACTION
2023-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COTELLIC · ReferencePrescription
COBIMETINIB FUMARATE EQ 20MG BASE · TABLET · ORAL

Approval history

2023-05-31Labeling · Supplement 6 · standard — Letter ↗AP
2022-10-28Efficacy · Supplement 5 · priority — Label ↗AP
2022-07-28Efficacy · Supplement 4 · priority — Letter ↗AP
2018-01-26Efficacy · Supplement 2 · standard — Label ↗AP
2016-05-31Labeling · Supplement 1 · standard — Label ↗AP
2015-11-10Type 1 - New Molecular Entity · Original · priority — Summary 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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