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FDA NDA · NDA212209

VIVIMUSTA

bendamustine hydrochloride

Sponsor: AZURITY

APPLICATION
NDA212209
TYPE
NDA
ORIGINAL APPROVAL
2022-12-07
LATEST ACTION
2024-02-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2024-02-27Labeling · Supplement 5 · standard — Label ↗AP
2024-02-08Labeling · Supplement 4 · standard — Letter ↗AP
2023-05-15Labeling · Supplement 3 · standard — Letter ↗AP
2022-12-07Type 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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