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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: DL-3-n-butylphthalide
Date Designated: 02/28/2018
Orphan Designation: Treatment of amyotrophic lateral sclerosis (ALS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CSPC NBP Pharmaceutical Co, Ltd, subsidiary of CSPC Pharma Group
No. 88 Yangzi Road
Shijiazhuang Shi, Hebei Sheng

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.