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Rebyota

fecal microbiota, live-jslm

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rebyota

Proper name

fecal microbiota, live-jslm

Licence type

351(a)

BLA number

125739

Applicant

Ferring Pharmaceuticals Inc.

Center

CBER

Presentations

First licensure

November 30, 2022

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
BETWEEN 1X10^8 AND 5X10^10CFU	Suspension	Rectal	Single-Use Bottle	Rx	November 30, 2022

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 30, 2029

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