← FDA DRUG APPROVALS

FDA NDA · NDA214018

NULIBRY

fosdenopterin hydrobromide

Sponsor: SENTYNL THERAPS INC

APPLICATION
NDA214018
TYPE
NDA
ORIGINAL APPROVAL
2021-02-26
LATEST ACTION
2026-05-26
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

NULIBRY · ReferencePrescription
FOSDENOPTERIN HYDROBROMIDE EQ 9.5MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-05-26Labeling · Supplement 3 · standard — Letter ↗AP
2022-10-27Efficacy · Supplement 2 · standard — Letter ↗AP
2021-02-26Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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