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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 1-(2-chlorophenyl)-1-(S)-hydroxy-2-(S)-carbamoyloxy-propane
Date Designated: 07/07/2016
Orphan Designation: Treatment of status epilepticus
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bio-Pharm Solutions Co., Ltd.
Greits Pangyo, 4th Floor
117 Bundangnaegok-ro
Bundang-gu, Seongnam-si, Gyeonggi-do 13529
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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