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FDA Drug information

Febuxostat

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20231004

Version

2

Spl Product Data Elements

febuxostat febuxostat FEBUXOSTAT FEBUXOSTAT SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE OVAL 401 febuxostat febuxostat FEBUXOSTAT FEBUXOSTAT SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 402

Application Number

ANDA205443

Brand Name

Febuxostat

Generic Name

febuxostat

Product Ndc

70771-1553

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Febuxostat Tablets, 40 mg – 30's count NDC- 70771-1552-3 Febuxostat Tablets, 80 mg – 30's count NDC- 70771-1553-3 40 mg label 80 mg label

Spl Medguide

SPL MEDGUIDE

Drug section

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