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FDA NDA · NDA208051

NERLYNX

neratinib

Sponsor: PUMA BIOTECH

APPLICATION
NDA208051
TYPE
NDA
ORIGINAL APPROVAL
2017-07-17
LATEST ACTION
2021-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NERLYNX · ReferencePrescription
NERATINIB MALEATE EQ 40MG BASE · TABLET · ORAL

Approval history

2021-06-28Efficacy · Supplement 9 · standard — Label ↗AP
2020-07-29Efficacy · Supplement 7 · standard — Letter ↗AP
2020-02-25Efficacy · Supplement 5 · standard — Letter ↗AP
2020-02-25Efficacy · Supplement 6 · standard — Letter ↗AP
2019-10-01Efficacy · Supplement 4 · standard — Letter ↗AP
2019-04-18Labeling · Supplement 3 · standard — Letter ↗AP
2018-06-28Labeling · Supplement 2 · standard — Label ↗AP
2017-07-17Type 1 - New Molecular Entity · Original · standard — 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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