Search Orphan Drug Designations and Approvals
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| Generic Name: | Hydrocortisone | |||||||||||||
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| 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 | |||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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 | |
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