General MedicationsIV (INFUSION)Standard
ELAPRASE
IDURSULFASE
Standard Dose
6MG/3ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ELAPRASE is listed in Drugs@FDA under application 125151 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IDURSULFASE Form and strength INJECTABLE; IV (INFUSION) - 6MG/3ML Sponsor SHIRE Submission history Latest submission status date: 2018-11-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview ELAPRASE is listed in Drugs@FDA under application 125151 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient IDURSULFASE Form and strength INJECTABLE; IV (INFUSION) - 6MG/3ML Sponsor SHIRE Submission history Latest submission status date: 2018-11-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.