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FDA Approval

Turalio

CompanyDaiichi Sankyo, Inc. (DUNS: 068605067)

Effective Date

November 21, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pexidartinib(125 mg in 1 1)

Products (1)

Turalio

NDC Product Code

65597-407

Application Number

NDA211810

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

POLOXAMER 407Inactive

Code: TUF2IVW3M2Class: IACT

PexidartinibActive

Code: YS6WAI3XN7Class: ACTIMQuantity: 125 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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