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FDA BLA · BLA761027

FILKRI

filgrastim-laha

Sponsor: ACCORD BIOPHARMA INC.

APPLICATION
BLA761027
TYPE
BLA
ORIGINAL APPROVAL
2026-01-15
LATEST ACTION
2026-01-15
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FILKRIPrescription
FILGRASTIM-LAHA 300MCG/0.5ML · INJECTABLE · INJECTION
FILKRIPrescription
FILGRASTIM-LAHA 480MCG/0.8ML · INJECTABLE · INJECTION

Approval history

2026-01-15UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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