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FDA NDA · NDA211530

BENDAMUSTINE HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA211530
TYPE
NDA
ORIGINAL APPROVAL
2022-12-15
LATEST ACTION
2024-01-25
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

BENDAMUSTINE HYDROCHLORIDE · ReferenceDiscontinued
BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) · SOLUTION · INTRAVENOUS
BENDAMUSTINE HYDROCHLORIDE · ReferenceDiscontinued
BENDAMUSTINE HYDROCHLORIDE 200MG/8ML (25MG/ML) · SOLUTION · INTRAVENOUS
BENDAMUSTINE HYDROCHLORIDE · ReferenceDiscontinued
BENDAMUSTINE HYDROCHLORIDE 25MG/ML (25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-01-25Labeling · Supplement 1 · standard — Label ↗AP
2022-12-15Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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