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Purple Book
Database of Licensed Biological Products

Product Details for: Zinplava
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous1,000MG/40ML (25MG/ML)Single-Dose Vial351(a)ZinplavaRx

Proper Name
bezlotoxumab

BLA Number
761046

Applicant
Merck Sharp & Dohme LLC

Original Approval Date
October 21, 2016

Date of First Licensure