IDOSE TR
NDA 218010 · New Drug Application (NDA) Prescription
TRAVOPROST
- 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 | IDOSE TR TRAVOPROST | IMPLANT;INTRACAMERAL 75MCG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 4 | Approved | standard | Efficacy | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (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) | |
| Original 1 | Approved | standard | 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
4 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 12201557Product 001 | Drug substance, Drug product | U-4129 | ||
| 10206813Product 001 | Drug product | – | ||
| 11426306Product 001 | Drug product | – | ||
| 12201555Product 001 | Drug substance, Drug product | – |
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.
iDose TR
TRAVOPROST INTRACAMERAL · Glaukos Corporation · INTRACAMERAL · Version 5 · effective
Indications and usage
1 INDICATIONS AND USAGE iDose ® TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). iDose ® TR is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 25357-100 in openFDA (opens in a new tab) | iDose TR Travoprost Intracameral | Glaukos Corporation | IMPLANT INTRACAMERAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
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.