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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205374


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NDA 205374 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 205374
Tradename:FEBUXOSTAT
Applicant:Dr Reddys
Ingredient:febuxostat
Patents:0
Pharmacology for NDA: 205374
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 205374
Suppliers and Packaging for NDA: 205374
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEBUXOSTAT febuxostat TABLET;ORAL 205374 ANDA DR REDDY'S LABORATORIES LIMITED 55111-796 55111-796-01 100 TABLET in 1 BOTTLE (55111-796-01)
FEBUXOSTAT febuxostat TABLET;ORAL 205374 ANDA DR REDDY'S LABORATORIES LIMITED 55111-796 55111-796-05 500 TABLET in 1 BOTTLE (55111-796-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 22, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Oct 22, 2020TE:ABRLD:No

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