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FDA NDA · NDA210656

DAURISMO

glasdegib

Sponsor: PFIZER

APPLICATION
NDA210656
TYPE
NDA
ORIGINAL APPROVAL
2018-11-21
LATEST ACTION
2023-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DAURISMO · ReferencePrescription
GLASDEGIB MALEATE EQ 100MG BASE · TABLET · ORAL
DAURISMO · ReferencePrescription
GLASDEGIB MALEATE EQ 25MG BASE · TABLET · ORAL

Approval history

2023-03-27Labeling · Supplement 5 · standard — Letter ↗AP
2020-03-19Labeling · Supplement 4 · standard — Label ↗AP
2020-03-19Labeling · Supplement 2 · standard — Label ↗AP
2018-11-21Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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