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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Hydrocortisone
Date Designated:  05/13/2015
Orphan Designation:  Treatment of pediatric adrenal insufficiency (0 through 16 years of age).
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/29/2020 
Approved Labeled Indication:  ALKINDI® SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency
Exclusivity End Date:     
Exclusivity Protected Indication* :  
Eton Pharmaceuticals, Inc.
21925 West Field Parkway, Suite 235
Deer Park, Illinois 60010
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.