← FDA DRUG APPROVALS

FDA NDA · NDA208169

XURIDEN

uridine triacetate

Sponsor: BTG INTL

APPLICATION
NDA208169
TYPE
NDA
ORIGINAL APPROVAL
2015-09-04
LATEST ACTION
2019-12-02
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

XURIDEN · ReferencePrescription
URIDINE TRIACETATE 2GM/PACKET · GRANULE · ORAL

Approval history

2019-12-02Efficacy · Supplement 3 · standard — Letter ↗AP
2015-09-04Type 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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