FERRIPROX

Basic Information

Product Name

FERRIPROX

FDA Product Code

52609-0006

Regulatory Information

NDC Product Code

52609-0006

Application Number

NDA021825

Marketing Category

C73594

Effective Date

April 27, 2011

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

DEFERIPRONE

Quantity: 500 mg in 1 1

Code: 2BTY8KH53L

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSE 2910 (15000 MPA.S)

Code: 288VBX44JC

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

DEFERIPRONE

Code: 2BTY8KH53L

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

SILICON DIOXIDE

POLYETHYLENE GLYCOL 3350

CELLULOSE, MICROCRYSTALLINE

HYPROMELLOSE 2910 (15000 MPA.S)

TITANIUM DIOXIDE

Active Moieties

DEFERIPRONE