← FDA DRUG APPROVALS

FDA BLA · BLA761082

RELEUKO

filgrastim

Sponsor: KASHIV BIOSCIENCES LLC

APPLICATION
BLA761082
TYPE
BLA
ORIGINAL APPROVAL
2022-02-25
LATEST ACTION
2025-04-29
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RELEUKOPrescription
FILGRASTIM-AYOW 300MCG/0.5ML · SOLUTION · SUBCUTANEOUS
RELEUKOPrescription
FILGRASTIM-AYOW 300MCG/ML/VIAL · SOLUTION · INTRAVENOUS, SUBCUTANEOUS
RELEUKOPrescription
FILGRASTIM-AYOW 480MCG/0.8ML · SOLUTION · SUBCUTANEOUS
RELEUKOPrescription
FILGRASTIM-AYOW 480MCG/1.6ML/VIAL · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

Approval history

2025-04-29BIOSIMILAR · Supplement 14 — Label ↗AP
2023-09-01BIOSIMILAR · Supplement 10 — Letter ↗AP
2022-10-28Labeling · Supplement 3 · standard — Letter ↗AP
2022-02-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

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