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Data updated: Mar 10, 2026

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

RIBOFLAVIN 5'-PHOSPHATE SODIUM
Gastroenterology Approved 2016-04-15
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
9
Years on Market

Details

Status
Prescription
First Approved
2016-04-15
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

GLAUKOS
Active Ingredient: RIBOFLAVIN 5'-PHOSPHATE SODIUM

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA Approval History

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What PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA Treats

4 indications

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA is approved for 4 conditions since its original approval in 2016. 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.

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA 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.

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Data Sources

FDA Approval: NDA203324 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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