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FDA NDA · NDA022249

TREANDA

bendamustine hydrochloride

Sponsor: CEPHALON

APPLICATION
NDA022249
TYPE
NDA
ORIGINAL APPROVAL
2008-03-20
LATEST ACTION
2022-10-25
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION, POWDER
MARKETING STATUS
Discontinued, Prescription

Products

TREANDA · ReferenceDiscontinued
BENDAMUSTINE HYDROCHLORIDE 180MG/2ML (90MG/ML) · SOLUTION · INTRAVENOUS
TREANDA · ReferencePrescription
BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · POWDER · INTRAVENOUS
TREANDA · ReferenceDiscontinued
BENDAMUSTINE HYDROCHLORIDE 45MG/0.5ML (90MG/ML) · SOLUTION · INTRAVENOUS
TREANDA · ReferencePrescription
BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2022-10-25Labeling · Supplement 26 · standard — Letter ↗AP
2021-06-10Labeling · Supplement 25 · standard — Label ↗AP
2019-11-21Labeling · Supplement 24 · standard — Label ↗AP
2017-12-15Labeling · Supplement 23 · standard — Letter ↗AP
2016-10-18Labeling · Supplement 22 · standard — Letter ↗AP
2015-11-05Labeling · Supplement 20 · standard — Label ↗AP
2015-09-02Labeling · Supplement 21 · standard — Label ↗AP
2015-07-08Manufacturing (CMC) · Supplement 18 · priorityAP
2015-03-10Labeling · Supplement 19 · standard — Label ↗AP
2014-03-27Manufacturing (CMC) · Supplement 17 · priorityAP
2013-09-13Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2013-08-28Labeling · Supplement 14 · standard — Label ↗AP
2012-06-26Labeling · Supplement 12 · standard — Pediatric Written Request ↗AP
2010-12-21Labeling · Supplement 6 · unknown — Label ↗AP
2010-02-26Labeling · Supplement 5 · 901 required — Label ↗AP
2009-05-01Manufacturing (CMC) · Supplement 1 — Label ↗AP
2009-04-22Labeling · Supplement 2 · standard — Letter ↗AP
2008-03-20Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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