Drug Index

ELAPRASE

Generic: IDURSULFASE

Review priority: STANDARD Marketing status: Prescription

Route: IV (INFUSION)
Class: General Medications
Safety profile: routine
Latest regulatory update: 16 Nov 2018, 12:00 am (UTC)

Structured Monograph

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.