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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

Sep 30, 2020Approval FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency
Dec  2, 2019Alkindi New Drug Application Submitted to US FDA

Further information

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