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FDA NDA · NDA214120

ONUREG

azacitidine

Sponsor: BRISTOL

APPLICATION
NDA214120
TYPE
NDA
ORIGINAL APPROVAL
2020-09-01
LATEST ACTION
2026-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ONUREG · ReferencePrescription
AZACITIDINE 200MG · TABLET · ORAL
ONUREG · ReferencePrescription
AZACITIDINE 300MG · TABLET · ORAL

Approval history

2026-04-09Efficacy · Supplement 3 · standard — Letter ↗AP
2021-05-17Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2020-09-01Type 3 - New Dosage Form · 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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