General MedicationsINJECTIONStandard
GRANIX
TBO-FILGRASTIM
Standard Dose
300MCG/0.5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GRANIX is listed in Drugs@FDA under application 125294 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TBO-FILGRASTIM Form and strength INJECTABLE; INJECTION - 300MCG/0.5ML Sponsor SICOR BIOTECH Submission history Latest submission status date: 2023-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview GRANIX is listed in Drugs@FDA under application 125294 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient TBO-FILGRASTIM Form and strength INJECTABLE; INJECTION - 300MCG/0.5ML Sponsor SICOR BIOTECH Submission history Latest submission status date: 2023-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.