PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA; PHOTREXA VISCOUS IN DEXTRAN 20%
NDA 203324 · New Drug Application (NDA) Prescription
RIBOFLAVIN 5'-PHOSPHATE SODIUM; RIBOFLAVIN 5'-PHOSPHATE
- 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 | PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA RIBOFLAVIN 5'-PHOSPHATE SODIUM | SOLUTION/DROPS;OPHTHALMIC EQ 0.146% BASE/ML;EQ 0.146% BASE/ML | Prescription | – | Reference listed drug, Reference standard | RXApproved |
| 002 | PHOTREXA VISCOUS IN DEXTRAN 20% RIBOFLAVIN 5'-PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC 0.146% | Prescription | – | Reference listed drug, Reference standard | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 10 | Approved | standard | Labeling | Letter for Supplement 10 (opens in a new tab)Label for Supplement 10 (opens in a new tab) | |
| Supplement 6 | Approved | standard | Labeling | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 7 | Approved | standard | Manufacturing (CMC) | None listed | |
| Original 2 | Approved | priority | Efficacy | Letter for Original 2 (opens in a new tab)Label for Original 2 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 3 - New Dosage Form | 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
No Orange Book exclusivities are listed for this application.
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.
Photrexa Cross-linking Kit
RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC · Glaukos Corporation · Version 26 · effective
Indications and usage
1 INDICATIONS AND USAGE PHOTREXA ® VISCOUS and PHOTREXA ® are indicated for use in corneal collagen cross-linking in combination with the KXL ® System for the treatment of PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus ( 1.1 ) and corneal ectasia following refractive surgery ( 1.2 ). 1.1 Progressive Keratoconus 1.2 Corneal Ectasia Following Refractive Surgery
Full label on DailyMed for Photrexa Cross-linking Kit (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 |
|---|---|---|---|---|---|
| 25357-025 in openFDA (opens in a new tab) | Photrexa Cross-linking Kit riboflavin 5-phosphate ophthalmic | Glaukos Corporation | KIT | NDA | From Ends |
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Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA 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.