BRYTLY
NDA 220341 · New Drug Application (NDA) Over-the-counter
APRACLONIDINE HYDROCHLORIDE
- 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 | BRYTLY APRACLONIDINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC EQ 0.125% BASE | Over-the-counter | – | Reference listed drug, Reference standard | Not listed |
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
No Orange Book exclusivities are listed for this application.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0065-8596 in openFDA (opens in a new tab) | BRYTLY Apraclonidine Hydrochloride | Alcon Laboratories, Inc. | SOLUTION/ DROPS OPHTHALMIC | 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.
- 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.