Search Orphan Drug Designations and Approvals
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Generic Name: | L-baclofen |
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Date Designated: | 01/06/1998 |
Orphan Designation: | Treatment of trigeminal neuralgia |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Osmotica Pharmaceutical Corp. 1205 Culbreth Dr. Suite 200 Wilmington, North Carolina 28405 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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