Orange Book product · Brand (NDA)

VISTOGARD

URIDINE TRIACETATE

Brand (NDA)NDA 208159RX BTG INTL

Dec 11, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 11, 2015
10 yr 8 mo ago
Today
Patent 7776838 expires
Listed method-of-use patent (U-1791) expiration.
Aug 17, 2027
in 1 yr 2 mo

Active ingredient

URIDINE TRIACETATE

Strength

10GM/PACKET

Dosage form

GRANULE

Route

ORAL

TE code

Not listed

Application

NDA 208159

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7776838	Aug 17, 2027	in 1 yr 2 mo	U-1791