Turalio
These highlights do not include all the information needed to use TURALIO safely and effectively. See full prescribing information for TURALIO. TURALIO (pexidartinib) capsules, for oral use Initial U.S. Approval: 2019
Approved
Approval ID
7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Daiichi Sankyo, Inc.
DUNS: 068605067
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pexidartinib hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-407
Application NumberNDA211810
Product Classification
M
Marketing Category
C73594
G
Generic Name
pexidartinib hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (9)
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
PEXIDARTINIB HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: YS6WAI3XN7
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT