NYVEPRIA
These highlights do not include all the information needed to use NYVEPRIA safely and effectively. See full prescribing information for NYVEPRIA. NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use Initial U.S. Approval: 2020
Approved
Approval ID
99d30b99-2743-446b-98f3-0430bf4ea869
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegfilgrastim-apgf
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0324
Application NumberBLA761111
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-apgf
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (6)
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT