Product Details for: Kovaltry 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 | For Injection | Intravenous | 1000IU | Single-Dose Vial | 351(a) | Kovaltry | Rx |
002 | For Injection | Intravenous | 250IU | Single-Dose Vial | 351(a) | Kovaltry | Rx |
003 | For Injection | Intravenous | 2000IU | Single-Dose Vial | 351(a) | Kovaltry | Rx |
004 | For Injection | Intravenous | 3000IU | Single-Dose Vial | 351(a) | Kovaltry | Rx |
005 | For Injection | Intravenous | 500IU | Single-Dose Vial | 351(a) | Kovaltry | Rx |
Proper Name
Antihemophilic Factor (Recombinant), Full Length
BLA Number
125574
Applicant
Bayer HealthCare LLC
Original Approval Date
March 16, 2016
Date of First Licensure