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kresladi

marnetegragene autotemcel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

kresladi

Proper name

marnetegragene autotemcel

Licence type

351(a)

BLA number

125806

Applicant

Rocket Pharmaceuticals Inc

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.34 to 6.1 10^6 cells/mL (including 0.32 to 6.1 10^6 CD34+ cells/mL)	Suspension	Intravenous	Bag	Rx	March 26, 2026

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