Fruzaqla
These highlights do not include all the information needed to use FRUZAQLA safely and effectively. See full prescribing information for FRUZAQLA. FRUZAQLA (fruquintinib) capsules, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
186d786e-dc8a-45f2-b5e1-01ac0201879f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fruquintinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63020-210
Application NumberNDA217564
Product Classification
M
Marketing Category
C73594
G
Generic Name
fruquintinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (8)
FRUQUINTINIBActive
Quantity: 1 mg in 1 1
Code: 49DXG3M5ZW
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
fruquintinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63020-225
Application NumberNDA217564
Product Classification
M
Marketing Category
C73594
G
Generic Name
fruquintinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (8)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FRUQUINTINIBActive
Quantity: 5 mg in 1 1
Code: 49DXG3M5ZW
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT