Search Orphan Drug Designations and Approvals
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Generic Name: | Amantadine HCl |
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Date Designated: | 07/20/2015 |
Orphan Designation: | Treatment of levodopa-induced dyskinesia |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 08/17/2018 |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Osmotica Pharmaceutical Corporation Regulatory, Clinical Operations & Legal Lumina Station #2, Suite 209-A Wilmington, North Carolina 28403 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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