EPIOXA HD/EPIOXA KIT
NDA 219910 · New Drug Application (NDA) Prescription
RIBOFLAVIN 5'-PHOSPHATE SODIUM
- Sponsor (Drugs@FDA)
- GLAUKOS Company: GLAUKOS Corp (GKOS)
- First approved
- Latest action
Drugs on HealthTrade
No drug on HealthTrade cites this application. Novel approvals since 2015 by healthcare companies HealthTrade covers are listed from Drugs@FDA automatically, labelled “Not yet reviewed”; editors link the others.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | EPIOXA HD/EPIOXA KIT RIBOFLAVIN 5'-PHOSPHATE SODIUM | SOLUTION/DROPS;OPHTHALMIC EQ 0.239% BASE/ML;EQ 0.177% BASE/ML | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | standard | Type 5 - New Formulation or New Manufacturer | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NP | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
EPIOXA CROSS-LINKING
RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC · Glaukos Corporation · OPHTHALMIC · Version 3 · effective
Indications and usage
1 INDICATIONS AND USAGE EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles. EPIOXA HD and EPIOXA are photoenhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles ( 1 ).
Full label on DailyMed for EPIOXA CROSS-LINKING (opens in a new tab)
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 25357-024 in openFDA (opens in a new tab) | EPIOXA CROSS-LINKING riboflavin 5-phosphate ophthalmic | Glaukos Corporation | KIT OPHTHALMIC | NDA | From |
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Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-11-03.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-11-03.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-11-03.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-11-03.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.