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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-[(2S)-2-methyl-1,4-dioxa-8-azaspiro[4.5]dec-8-yl]-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one
Date Designated: 03/15/2018
Orphan Designation: Treatment of Tuberculosis (TB)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Klinikum der Universität München
15 Marchioninistr.
München, Bayern
Germany

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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