Alkindi Sprinkle FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 19, 2021.
FDA Approved: Yes (First approved September 29, 2020)
Brand name: Alkindi Sprinkle
Generic name: hydrocortisone
Dosage form: Oral Granules
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency
Alkindi Sprinkle (hydrocortisone granules in capsules for opening) is an immediate-release pediatric formulation of the approved glucocorticoid hydrocortisone for the treatment of adrenocortical insufficiency in infants, children and adolescents.
Development timeline for Alkindi Sprinkle
| Date | Article |
|---|---|
| Sep 30, 2020 | Approval FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency |
| Dec 2, 2019 | Alkindi New Drug Application Submitted to US FDA |
Further information
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