Product Details for: Obizur Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | For Injection | Intravenous | 500U | Single-Dose Vial | 351(a) | Obizur | Rx |
Proper Name
Antihemophilic Factor (Recombinant), Porcine Sequence
BLA Number
125512
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
October 23, 2014
Date of First Licensure