Deferasirox Oral Granules
These highlights do not include all the information needed to use DEFERASIROX ORAL GRANULES safely and effectively. See full prescribing information for DEFERASIROX ORAL GRANULES. DEFERASIROX oral granules, for oral useInitial U.S. Approval: 2005
Approved
Approval ID
7eda83c3-a282-47f6-9f06-d2f9612f5c5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
EPIC PHARMA, LLC
DUNS: 827915443
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-372
Application NumberANDA214559
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEFERASIROXActive
Quantity: 180 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-373
Application NumberANDA214559
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DEFERASIROXActive
Quantity: 360 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-371
Application NumberANDA214559
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (7)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
DEFERASIROXActive
Quantity: 90 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT