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FDA NDA · NDA021248

TRISENOX

arsenic trioxide

Sponsor: CEPHALON

APPLICATION
NDA021248
TYPE
NDA
ORIGINAL APPROVAL
2000-09-25
LATEST ACTION
2020-10-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

TRISENOX · ReferencePrescription
ARSENIC TRIOXIDE 2MG/ML · INJECTABLE · INJECTION
TRISENOX · ReferenceDiscontinued
ARSENIC TRIOXIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-10-20Labeling · Supplement 19 · standard — Label ↗AP
2019-06-20Labeling · Supplement 18 · standard — Label ↗AP
2018-01-12Efficacy · Supplement 15 · priority — Letter ↗AP
2015-02-20Labeling · Supplement 13 · standard — Letter ↗AP
2010-07-23Labeling · Supplement 9 · standard — Label ↗AP
2010-07-23Labeling · Supplement 8 · standard — Label ↗AP
2003-01-07Manufacturing (CMC) · Supplement 2 · priorityAP
2001-06-13Manufacturing (CMC) · Supplement 1 · priorityAP
2000-09-25Type 1 - New Molecular Entity · Original · priority — Review ↗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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