• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
Generic Name:  Amantadine HCl
Date Designated:  07/20/2015
Orphan Designation:  Treatment of levodopa-induced dyskinesia
Orphan Designation Status:  Designated/Withdrawn
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.