Viewing data from:

XURIDEN

NDA

URIDINE TRIACETATE | N208169 | BTG INTERNATIONAL INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CALBIOCHEM BEHRING CORPInactiveURIDINE

DMF 18151971

SIGMA F AND D DIV LTDInactiveURIDINE

DMF 33491978

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 3, 2019	SUPPL -3	View Letter (PDF)
Sep 10, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2GM/PACKET

RLD

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Sep 4, 2015

No patent or exclusivity listings for this strength.