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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
Trade Name: ALKINDI® SPRINKLE
Date Designated: 05/13/2015
Orphan Designation: Treatment of pediatric adrenal insufficiency (0 through 16 years of age).
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: Hydrocortisone
Trade Name: ALKINDI® SPRINKLE
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: TBD  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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