Product Details for: ELEVIDYS

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
Suspension
Intravenous
1.33 10E14 vector genomes (vg)/kg/bodyweight(bw)
Single-Dose Vial
351(a)
ELEVIDYS
Rx
Proper Name
delandistrogene moxeparvovec-rokl
BLA Number
125781
Applicant
Sarepta Therapeutics, Inc.
Original Approval Date
June 22, 2023
Date of First Licensure
06/22/2023
RETURN TO SEARCH RESULTS