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FDA NDA · NDA209401

VYXEOS

(daunorubicin and cytarabine) liposome

Sponsor: JAZZ PHARMS THERAP

APPLICATION
NDA209401
TYPE
NDA
ORIGINAL APPROVAL
2017-08-03
LATEST ACTION
2026-01-27
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VYXEOS · ReferencePrescription
CYTARABINE 100MG, DAUNORUBICIN 44MG · POWDER · INTRAVENOUS

Approval history

2026-01-27Efficacy · Supplement 18 · priority — Letter ↗AP
2022-09-27Efficacy · Supplement 11 · standard — Letter ↗AP
2021-03-30Efficacy · Supplement 6 · priority — Label ↗AP
2020-01-13Labeling · Supplement 2 · standard — Letter ↗AP
2017-08-03Type 4 - New Combination · 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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