INVELTYS
NDA 210565 · New Drug Application (NDA) Discontinued
LOTEPREDNOL ETABONATE
- Sponsor (Drugs@FDA)
- ALCON LABS INC Company: ALCON INC (ALC)
- 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 | INVELTYS LOTEPREDNOL ETABONATE | SUSPENSION/DROPS;OPHTHALMIC 1% | Discontinued | – | Reference listed drug | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| 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
14 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10058511Product 001 | Drug product | U-2492 | ||
| 10646437Product 001 | Drug product | – | ||
| 10688045Product 001 | Drug product | – | ||
| 10864219Product 001 | Method of use | U-3011 | ||
| 11219597Product 001 | Method of use | U-3278 | ||
| 11219597Product 001 | Method of use | U-3279 | ||
| 11642317Product 001 | Drug product | – | ||
| 11872318Product 001 | Drug product | – | ||
| 12115246Product 001 | Drug product | U-4025 | ||
| 9056057Product 001 | Drug product | U-2491 | ||
| 9393213Product 001 | Drug product | – | ||
| 9532955Product 001 | Method of use | U-2491 | ||
| 9737491Product 001 | Method of use | U-2492 | ||
| 9827191Product 001 | Drug product | U-2493 |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
No NDC directory product carries this application number.
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.
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.