Product Details for: Zinplava
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1,000MG/40ML (25MG/ML)
Single-Dose Vial
351(a)
Zinplava
Rx
Proper Name
bezlotoxumab
bezlotoxumab
BLA Number
761046
761046
Applicant
Merck Sharp & Dohme LLC
Merck Sharp & Dohme LLC
Original Approval Date
October 21, 2016
October 21, 2016
Date of First Licensure