Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Partner Therapeutics
Partner Therapeutics, Inc.
081059614
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Leukine
Product Details
NDC Product Code
71837-5843Application Number
BLA103362Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUS, INTRAVENOUSEffective Date
August 31, 2023SargramostimActive
Code: 5TAA004E22Class: ACTIBQuantity: 250 ug in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 40 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 10 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 1.2 mg in 1 mL