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Data updated: Mar 10, 2026

EPIOXA HD/EPIOXA KIT

RIBOFLAVIN 5'-PHOSPHATE SODIUM
Gastroenterology Approved 2025-10-17
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-10-17
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

GLAUKOS
Active Ingredient: RIBOFLAVIN 5'-PHOSPHATE SODIUM

EPIOXA HD/EPIOXA KIT Approval History

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What EPIOXA HD/EPIOXA KIT Treats

4 indications

EPIOXA HD/EPIOXA KIT is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Fever
  • Burns
  • Gastrointestinal Disorder
  • Alcoholism
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

EPIOXA HD/EPIOXA KIT FDA Label Details

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Indications & Usage

FDA Label (PDF)

In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

EPIOXA HD/EPIOXA KIT Patents & Exclusivity

Exclusivity: Oct 2028

Exclusivity

NP Until Oct 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA219910 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.