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Khindivi FDA Approval History

Last updated by Judith Stewart, BPharm on March 6, 2025.

FDA Approved: Yes (First approved May 28, 2025)
Brand name: Khindivi
Generic name: hydrocortisone
Dosage form: Oral Solution
Previous Name: ET-400
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency

ET-400 (hydrocortisone) is a proprietary, room temperature stable, oral solution formulation of the approved glucocorticoid hydrocortisone in development for use in children.

Development timeline for Khindivi

DateArticle
Feb  6, 2025Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400
Jul 15, 2024Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Apr 30, 2024Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

Further information

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