← FDA DRUG APPROVALS

FDA NDA · NDA208194

BENDEKA

bendamustine hydrochloride

Sponsor: EAGLE PHARMS

APPLICATION
NDA208194
TYPE
NDA
ORIGINAL APPROVAL
2015-12-07
LATEST ACTION
2024-01-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BENDEKA · ReferencePrescription
BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-01-11Labeling · Supplement 26 · standard — Letter ↗AP
2021-10-14Labeling · Supplement 24 · standard — Label ↗AP
2019-11-08Labeling · Supplement 20 · standard — Letter ↗AP
2019-10-08Labeling · Supplement 19 · standard — Letter ↗AP
2018-07-30Labeling · Supplement 13 · standard — Label ↗AP
2017-02-09Labeling · Supplement 5 · standard — Label ↗AP
2017-02-06UNKNOWN · Supplement 4 · standard — Review ↗AP
2016-09-23UNKNOWN · Supplement 3 · unknown — Review ↗AP
2016-06-23Labeling · Supplement 1 · standard — Label ↗AP
2016-06-23Labeling · Supplement 2 · standard — Label ↗AP
2015-12-07Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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