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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
Trade Name: SEIZALAM
Date Designated: 02/04/2016
Orphan Designation: Treatment of status epilepticus
Orphan Designation Status: Designated/Approved
Meridian Medical Technologies
6350 Stevens Forest Road
Suite 301
Columbia, Maryland 21046
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: midazolam
Trade Name: SEIZALAM
Marketing Approval Date: 09/14/2018
Approved Labeled Indication: SEIZALAM is indicated for the treatment of status epilepticus in adults.
Exclusivity End Date: 09/14/2025 
Exclusivity Protected Indication* :  SEIZALAM is indicated for the treatment of status epilepticus in adults.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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