General MedicationsINJECTIONStandard
SAPHNELO
ANIFROLUMAB-FNIA
Standard Dose
300MG/2ML(150MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SAPHNELO is listed in Drugs@FDA under application 761123 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ANIFROLUMAB-FNIA Form and strength INJECTABLE;INJECTION - 300MG/2ML(150MG/ML) Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2024-08-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview SAPHNELO is listed in Drugs@FDA under application 761123 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ANIFROLUMAB-FNIA Form and strength INJECTABLE;INJECTION - 300MG/2ML(150MG/ML) Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2024-08-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.