Xospata
These highlights do not include all the information needed to use XOSPATA safely and effectively. See full prescribing information for XOSPATA. XOSPATA (gilteritinib) tablets, for oral useInitial U.S. Approval: 2018
Approved
Approval ID
b5ff59aa-9c0d-49a8-9053-1f179b482383
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2022
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gilteritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-1425
Application NumberNDA211349
Product Classification
M
Marketing Category
C73594
G
Generic Name
gilteritinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2022
FDA Product Classification
INGREDIENTS (10)
GILTERITINIB FUMARATEActive
Quantity: 40 mg in 1 1
Code: 5RZZ0Z1GJT
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT