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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021856

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NDA 021856 describes ULORIC, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from five suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ULORIC profile page.

The generic ingredient in ULORIC is febuxostat. There are twenty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 021856
Tradename:ULORIC
Applicant:Takeda Pharms Usa
Ingredient:febuxostat
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 021856
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 021856
Suppliers and Packaging for NDA: 021856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULORIC febuxostat TABLET;ORAL 021856 NDA Rebel Distributors Corp 21695-516 E 21695-516-30
ULORIC febuxostat TABLET;ORAL 021856 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-305 N 43353-305-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Feb 13, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES ON PATIENTS WITH SEVERE RENAL IMPAIRMENT
Patent:➤ Try a Free TrialPatent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
Patent:➤ Try a Free TrialPatent Expiration:Jun 18, 2019Product Flag?Substance Flag?YDelist Request?

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