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FDA NDA · NDA213591

TABRECTA

capmatinib

Sponsor: NOVARTIS PHARM

APPLICATION
NDA213591
TYPE
NDA
ORIGINAL APPROVAL
2020-05-06
LATEST ACTION
2024-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TABRECTA · ReferencePrescription
CAPMATINIB HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
TABRECTA · ReferencePrescription
CAPMATINIB HYDROCHLORIDE EQ 200MG BASE · TABLET · ORAL

Approval history

2024-03-14Labeling · Supplement 11 · standard — Letter ↗AP
2023-03-24Labeling · Supplement 7 · standard — Letter ↗AP
2022-08-10Efficacy · Supplement 4 · priority — Letter ↗AP
2022-01-21Labeling · Supplement 2 · standard — Letter ↗AP
2020-05-06Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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