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encelto

revakinagene taroretcel-lwey

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

encelto

Proper name

revakinagene taroretcel-lwey

Licence type

351(a)

BLA number

125798

Applicant

Neurotech Pharmaceuticals Inc.

Center

CBER

Presentations

First licensure

March 5, 2025

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
200,000-440,000CELLS/IMPLANT	Implant	Implantation	Capsule	Rx	March 5, 2025

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 5, 1932

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