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Rethymic

allogeneic processed thymus tissue-agdc

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rethymic

Proper name

allogeneic processed thymus tissue-agdc

Licence type

351(a)

BLA number

125685

Applicant

Sumitomo Pharma America, Inc.

Center

CBER

Presentations

First licensure

October 8, 2021

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
SEMI-QUANTITATIVE	For Suspension	Implantation	Dish	Rx	October 8, 2021

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 8, 2028

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