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Hydrocortisone liquid - Eton Pharmaceuticals

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Drug Profile

Hydrocortisone liquid - Eton Pharmaceuticals

Alternative Names: ET-400; ET-800; Hydrocortisone vial; KHINDIVI

Latest Information Update: 01 Sep 2025

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At a glance

  • Originator Crossject
  • Developer Eton Pharmaceuticals
  • Class Alcohols; Anti-inflammatories; Antiallergics; Glucocorticoids; Pregnenediones; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Adrenal insufficiency
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Adrenal insufficiency

Most Recent Events

  • 07 Aug 2025 Eton Pharmaceuticals expects supplement new drug application (sNDA) approval for Hydrocortisone liquid before the end of 2026
  • 07 Aug 2025 Eton Pharmaceuticals expects to file a supplement new drug application (sNDA) for Hydrocortisone liquid in the first half of 2026
  • 07 Aug 2025 Eton Pharmaceuticals plans a pre-submission meeting with the FDA in September 2025

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