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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  tacrolimus
Date Designated:  06/16/2020
Orphan Designation:  Prophylaxis of lung allograft rejection
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
TFF Pharmaceuticals, Inc.
2600 Via Fortuna, Suite 360
Austin, Texas 78746
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.
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