Leukine
These highlights do not include all the information needed to use LEUKINE safely and effectively. See full prescribing information for LEUKINE. LEUKINE (sargramostim) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 1991
Approved
Approval ID
bb9a3820-f31a-4dd9-bef4-97094c01a398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Partner Therapeutics, Inc.
DUNS: 080709490
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SARGRAMOSTIM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71837-5843
Application NumberBLA103362
Product Classification
M
Marketing Category
C73585
G
Generic Name
SARGRAMOSTIM
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (6)
SARGRAMOSTIMActive
Quantity: 250 ug in 1 mL
Code: 5TAA004E22
Classification: ACTIB
MANNITOLInactive
Quantity: 40 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 1 mL
Code: C151H8M554
Classification: IACT
TROMETHAMINEInactive
Quantity: 1.2 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT