General MedicationsINTRAVENOUSStandard
ELITEK
RASBURICASE
Standard Dose
1.5MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ELITEK is listed in Drugs@FDA under application 103946 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RASBURICASE Form and strength VIAL; INTRAVENOUS - 1.5MG/VIAL Sponsor SANOFI SYNTHELABO Submission history Latest submission status date: 2019-12-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview ELITEK is listed in Drugs@FDA under application 103946 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RASBURICASE Form and strength VIAL; INTRAVENOUS - 1.5MG/VIAL Sponsor SANOFI SYNTHELABO Submission history Latest submission status date: 2019-12-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.