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ET-400 FDA Approval Status

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

FDA Approved: No
Brand name: ET-400
Generic name: hydrocortisone
Dosage form: Oral Solution
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 ET-400

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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