Product Details for: Rebyota

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Rectal
BETWEEN 1X10^8 AND 5X10^10CFU
Single-Use Bottle
351(a)
Rebyota
Rx
Proper Name
fecal microbiota, live-jslm
BLA Number
125739
Applicant
Ferring Pharmaceuticals Inc.
Original Approval Date
November 30, 2022
Date of First Licensure
11/30/2022
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