APPLICATION
BLA761126
TYPE
BLA
ORIGINAL APPROVAL
2024-06-28
LATEST ACTION
2024-06-28
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NYPOZIPrescription
FILGRASTIM-TXID 300MCG/0.5ML · INJECTABLE · INJECTION
NYPOZIPrescription
FILGRASTIM-TXID 480MCG/0.8ML · INJECTABLE · INJECTION
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.