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FDA NDA · NDA216078

BENDAMUSTINE HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA216078
TYPE
NDA
ORIGINAL APPROVAL
2022-12-15
LATEST ACTION
2024-02-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2024-02-26Labeling · Supplement 2 · standard — Letter ↗AP
2022-12-15Type 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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