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FDA NDA · NDA206256

BELEODAQ

belinostat

Sponsor: ACROTECH BIOPHARMA

APPLICATION
NDA206256
TYPE
NDA
ORIGINAL APPROVAL
2014-07-03
LATEST ACTION
2024-11-19
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BELEODAQ · ReferencePrescription
BELINOSTAT 500MG/VIAL · POWDER · INTRAVENOUS

Approval history

2024-11-19Labeling · Supplement 6 · standard — Label ↗AP
2022-04-20Labeling · Supplement 4 · standard — Label ↗AP
2020-01-08Labeling · Supplement 3 · standard — Letter ↗AP
2017-04-12Labeling · Supplement 2 · standard — Label ↗AP
2015-04-23Manufacturing (CMC) · Supplement 1 · priorityAP
2014-07-03Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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