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FDA NDA · NDA211288

VIZIMPRO

dacomitinib

Sponsor: PFIZER

APPLICATION
NDA211288
TYPE
NDA
ORIGINAL APPROVAL
2018-09-27
LATEST ACTION
2020-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VIZIMPRO · ReferenceDiscontinued
DACOMITINIB 30MG · TABLET · ORAL
VIZIMPRO · ReferenceDiscontinued
DACOMITINIB 45MG · TABLET · ORAL
VIZIMPRO · ReferenceDiscontinued
DACOMITINIB 15MG · TABLET · ORAL

Approval history

2020-12-18Labeling · Supplement 3 · standard — Letter ↗AP
2018-09-27Type 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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