deferasirox
These highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral suspension Initial U.S. Approval: 2005
Approved
Approval ID
4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-568
Application NumberANDA209782
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (8)
DEFERASIROXActive
Quantity: 125 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-570
Application NumberANDA209782
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
DEFERASIROXActive
Quantity: 500 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-569
Application NumberANDA209782
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (8)
DEFERASIROXActive
Quantity: 250 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT