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FDA NDA · NDA216387

CALQUENCE

acalabrutinib

Sponsor: ASTRAZENECA

APPLICATION
NDA216387
TYPE
NDA
ORIGINAL APPROVAL
2022-08-03
LATEST ACTION
2026-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CALQUENCE · ReferencePrescription
ACALABRUTINIB MALEATE EQ 100MG BASE · TABLET · ORAL

Approval history

2026-02-19Efficacy · Supplement 6 · standard — Letter ↗AP
2025-01-16Efficacy · Supplement 5 · priority — Label ↗AP
2024-06-05Labeling · Supplement 4 · 901 required — Label ↗AP
2022-08-03Type 3 - New Dosage Form · Original · standard — Label ↗AP
2022-08-03Type 3 - New Dosage Form · Original · standard — Letter ↗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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