Product Details for: Adstiladrin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Suspension
Intravesical
3x10^11 viral particles (vp)/mL
Single-Dose Vial
351(a)
Adstiladrin
Rx
Proper Name
nadofaragene firadenovec-vncg
nadofaragene firadenovec-vncg
BLA Number
125700
125700
Applicant
Ferring Pharmaceuticals A/S
Ferring Pharmaceuticals A/S
Original Approval Date
December 16, 2022
December 16, 2022
Date of First Licensure
12/16/2022
12/16/2022