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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Choline chloride
Date Designated: 02/10/1994
Orphan Designation: Treatment of choline deficiency, specifically the choline deficiency, hepatic steatosis, and cholestasis, associated with long-term parenteral nutrition.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Protara Therapeutics, Inc.
345 Park Avenue South, 3rd Floor
New York, New York 10010
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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