Fulphila
These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA (pegfilgrastim-jmdb) is biosimilar* to NEULASTA (pegfilgrastim). (1)
Approved
Approval ID
9bfc4d3e-6120-7fec-f1d6-0b3743752034
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Biocon Biologics Inc.
DUNS: 117609395
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegfilgrastim-jmdb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-005
Application NumberBLA761075
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-jmdb
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT