FERRIPROX
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
Approved
Approval ID
dc8cbc3d-026c-0db5-42e8-8e93d374dd23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2020
Manufacturers
FDA
ApoPharma USA, Inc.
DUNS: 962810821
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deferiprone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52609-0006
Application NumberNDA021825
Product Classification
M
Marketing Category
C73594
G
Generic Name
deferiprone
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2011
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
DEFERIPRONEActive
Quantity: 500 mg in 1 1
Code: 2BTY8KH53L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT