MedPath
FDA Product

FERRIPROX

Product approved by U.S. Food and Drug Administration (US)

Basic Information

FERRIPROX

10122-100

Regulatory Information

10122-100

NDA021825

C73594

August 14, 2021

USA

These highlights do not include all the information needed to use FERRIPROX Tablets safely and effectively. See full prescribing information for FERRIPROX Tablets.FERRIPROX (deferiprone) tablets, for oral useInitial U.S. Approval: 2011

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Chiesi USA, Inc.

088084228

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

DEFERIPRONE

Quantity: 500 mg in 1 1

Code: 2BTY8KH53L

Class Code: ACTIB

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (15000 MPA.S)

Code: 288VBX44JC

Class Code: IACT

Active Moieties

DEFERIPRONE

Code: 2BTY8KH53L

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