General MedicationsINJECTIONStandard
SYLVANT
SILTUXIMAB
Standard Dose
400MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SYLVANT is listed in Drugs@FDA under application 125496 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SILTUXIMAB Form and strength INJECTABLE;INJECTION - 400MG Sponsor RECORDATI RARE DISEASES, INC.
Structured Monograph
Clinical summary
Approval overview SYLVANT is listed in Drugs@FDA under application 125496 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SILTUXIMAB Form and strength INJECTABLE;INJECTION - 400MG Sponsor RECORDATI RARE DISEASES, INC. Submission history Latest submission status date: 2019-12-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.