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Adstiladrin

nadofaragene firadenovec-vncg

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Adstiladrin

Proper name

nadofaragene firadenovec-vncg

Licence type

351(a)

BLA number

125700

Applicant

Ferring Pharmaceuticals A/S

Center

CBER

Presentations

First licensure

December 16, 2022

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
3x10^11 viral particles (vp)/mL	For Suspension	Intravesical	Single-Dose Vial	Rx	December 16, 2022

Purple Book	FDA	Licence type, presentations, reference product, exclusivity