STIMUFEND
These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND (pegfilgrastim-fpgk) injection, for subcutaneous useInitial U.S. Approval: 2022
Approved
Approval ID
b44bcb82-7e60-4dab-a658-115bdf5c053c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegflilgrastim-fpgk
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-371
Application NumberBLA761173
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegflilgrastim-fpgk
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 15, 2022
FDA Product Classification
INGREDIENTS (6)
ACETATE IONInactive
Code: 569DQM74SC
Classification: IACT
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT