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FDA NDA · NDA208159

VISTOGARD

uridine triacetate

Sponsor: BTG INTL

APPLICATION
NDA208159
TYPE
NDA
ORIGINAL APPROVAL
2015-12-11
LATEST ACTION
2016-06-07
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

VISTOGARD · ReferencePrescription
URIDINE TRIACETATE 10GM/PACKET · GRANULE · ORAL

Approval history

2016-06-07Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
2016-03-29Labeling · Supplement 1 · standard — Label ↗AP
2015-12-11Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · 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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