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Express Scripts
Johnson and Johnson

Last Updated: May 30, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210292

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NDA 210292 describes FEBUXOSTAT, which is a drug marketed by Alembic Pharms Ltd, Hikma, Indoco Remedies, MSN, Mylan, and Sun Pharm, and is included in six NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
Summary for 210292
Applicant:Indoco Remedies
Formulation / Manufacturing:see details
Pharmacology for NDA: 210292
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 210292
Suppliers and Packaging for NDA: 210292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEBUXOSTAT febuxostat TABLET;ORAL 210292 ANDA Indoco Remedies Limited 14445-156 14445-156-05 500 TABLET, FILM COATED in 1 BOTTLE (14445-156-05)
FEBUXOSTAT febuxostat TABLET;ORAL 210292 ANDA Indoco Remedies Limited 14445-156 14445-156-30 30 TABLET, FILM COATED in 1 BOTTLE (14445-156-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 30, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Dec 30, 2019TE:ABRLD:No

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