You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

Details for New Drug Application (NDA): 205467


✉ Email this page to a colleague

« Back to Dashboard


NDA 205467 describes FEBUXOSTAT, which is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the FEBUXOSTAT profile page.

The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 205467
Tradename:FEBUXOSTAT
Applicant:Sun Pharm
Ingredient:febuxostat
Patents:0
Pharmacology for NDA: 205467
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 205467
Suppliers and Packaging for NDA: 205467
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEBUXOSTAT febuxostat TABLET;ORAL 205467 ANDA NorthStar RxLLC 16714-059 16714-059-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-059-01)
FEBUXOSTAT febuxostat TABLET;ORAL 205467 ANDA NorthStar RxLLC 16714-060 16714-060-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-060-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 1, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jul 1, 2019TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.