Product Details for: Zinplava Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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
BLA Number
761046
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
October 21, 2016
Date of First Licensure