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NULIBRY

NDA · New Drug Application · Sponsor: SENTYNL THERAPS INC · Approved 2021-02-26

Drug application

FDA Application #

NDA214018

Application type

New Drug Application

Brand name

NULIBRY

Generic name

FOSDENOPTERIN HYDROBROMIDE

Active ingredients

FOSDENOPTERIN HYDROBROMIDE

Dosage form

POWDER

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

SENTYNL THERAPS INC

Manufacturer

Sentynl Therapeutics, Inc.

First approval

2021-02-26

Source

Authoritative

Drugs@FDA application overview

Machine

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