FYLNETRA
FYLNETRA (pegfilgrastim-pbbk) is biosimilar* to NEULASTA (pegfilgrastim).
Approved
Approval ID
eeadd641-573d-47fe-897a-61006e5f9e03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegfilgrastim
PRODUCT DETAILS
NDC Product Code70121-1627
Application NumberBLA761084
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 31, 2023
Generic Namepegfilgrastim
INGREDIENTS (6)
ACETIC ACIDInactive
Quantity: 0.36 mg in 0.6 mL
Code: Q40Q9N063P
Classification: IACT
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
SORBITOLInactive
Quantity: 30 mg in 0.6 mL
Code: 506T60A25R
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.02 mg in 0.6 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 0.03 mg in 0.6 mL
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT