General MedicationsINJECTIONStandard
FILKRI
FILGRASTIM-LAHA
Standard Dose
480MCG/0.8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FILKRI is listed in Drugs@FDA under application 761027 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-LAHA Form and strength INJECTABLE;INJECTION - 480MCG/0.8ML Sponsor ACCORD BIOPHARMA INC.
Structured Monograph
Clinical summary
Approval overview FILKRI is listed in Drugs@FDA under application 761027 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-LAHA Form and strength INJECTABLE;INJECTION - 480MCG/0.8ML Sponsor ACCORD BIOPHARMA INC. Submission history Latest submission status date: 2026-01-15 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.