Product Details for: Kcentra

RETURN TO SEARCH RESULTS
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
500IU
Single-Dose Vial
351(a)
Kcentra
Rx
002
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Kcentra
Rx
Proper Name
Prothrombin Complex Concentrate (Human)
BLA Number
125421
Applicant
CSL Behring GmbH
Original Approval Date
April 29, 2013
Date of First Licensure
RETURN TO SEARCH RESULTS