MedPath
FDA Product

FERRIPROX

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

Basic Information

FERRIPROX

10122-104

Regulatory Information

10122-104

NDA212269

C73594

July 27, 2023

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 use Initial U.S. Approval: 2011

HUMAN PRESCRIPTION DRUG LABEL

11

Company Information

Chiesi USA, Inc.

088084228

Active Ingredients

DEFERIPRONE

Quantity: 1000 mg in 1 1

Code: 2BTY8KH53L

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MAGNESIUM OXIDE

Code: 3A3U0GI71G

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

Code: NX76LV5T8J

Class Code: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)

Code: 6N003M473W

Class Code: IACT

Active Moieties

DEFERIPRONE

Code: 2BTY8KH53L

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