← FDA DRUG APPROVALS

FDA NDA · NDA214096

TEPMETKO

tepotinib hydrochloride

Sponsor: EMD SERONO INC

APPLICATION
NDA214096
TYPE
NDA
ORIGINAL APPROVAL
2021-02-03
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TEPMETKO · ReferencePrescription
TEPOTINIB HYDROCHLORIDE EQ 225MG BASE · TABLET · ORAL

Approval history

2024-02-15Efficacy · Supplement 3 · standard — Label ↗AP
2023-03-23Labeling · Supplement 1 · standard — Letter ↗AP
2023-03-23Labeling · Supplement 2 · standard — Letter ↗AP
2021-02-03Type 1 - New Molecular Entity · Original · priority — Label ↗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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