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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: midazolam
Date Designated: 02/18/2016
Orphan Designation: Treatment of status epilepticus
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Laboratorios Lesvi, S.L.
Avda. Barcelona 69
Sant Joan Despí, Barcelona 08970
Spain

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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