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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: encochleated amikacin
Date Designated: 03/03/2016
Orphan Designation: Treatment of non-tuberculous mycobacteria (NTM) infections
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Matinas BioPharma Nanotechnologies, Inc
1545 Route 206 South, Suite 302
Bedminster Township, New Jersey 07921
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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