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FDA BLA · BLA761046

ZINPLAVA

bezlotoxumab

Sponsor: MERCK SHARP DOHME

APPLICATION
BLA761046
TYPE
BLA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2023-05-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZINPLAVAPrescription
BEZLOTOXUMAB 1000ML/40ML · INJECTABLE · INJECTION

Approval history

2023-05-26Efficacy · Supplement 12 · priority — Label ↗AP
2016-10-21Type 1 - New Molecular Entity · Original · priority — 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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