Product Details for: Darzalex

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
Injection
Intravenous
100MG/5ML
Single-Dose Vial
351(a)
Darzalex
Rx
002
Injection
Intravenous
400MG/20ML
Single-Dose Vial
351(a)
Darzalex
Rx
Proper Name
daratumumab
BLA Number
761036
Applicant
Janssen Biotech, Inc.
Original Approval Date
November 16, 2015
Date of First Licensure
RETURN TO SEARCH RESULTS