TETRACAINE HYDROCHLORIDE
NDA 208135 · New Drug Application (NDA) Prescription
TETRACAINE HYDROCHLORIDE
- Sponsor (Drugs@FDA)
- ALCON LABS 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 | TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE | SOLUTION;OPHTHALMIC 0.5% | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 7 - Drug Already Marketed without Approved NDA | 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.
Tetracaine Hydrochloride
TETRACAINE HYDROCHLORIDE · REMEDYREPACK INC. · OPHTHALMIC · Version 3 · effective
Indications and usage
1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )
Full label on DailyMed for Tetracaine Hydrochloride (opens in a new tab)
Tetracaine Hydrochloride
TETRACAINE HYDROCHLORIDE · A-S Medication Solutions · OPHTHALMIC · Version 9 · effective
Indications and usage
1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )
Full label on DailyMed for Tetracaine Hydrochloride (opens in a new tab)
Tetracaine Hydrochloride
TETRACAINE HYDROCHLORIDE · Alcon Laboratories, Inc. · OPHTHALMIC · Version 14 · effective
Indications and usage
1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )
Full label on DailyMed for Tetracaine Hydrochloride (opens in a new tab)
NDC products
3 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0065-0741 in openFDA (opens in a new tab) | Tetracaine Hydrochloride tetracaine hydrochloride | Alcon Laboratories, Inc. | SOLUTION OPHTHALMIC | NDA | From |
| 50090-2364 in openFDA (opens in a new tab) | Tetracaine Hydrochloride tetracaine hydrochloride | A-S Medication Solutions | SOLUTION OPHTHALMIC | NDA | From |
| 70518-4183 in openFDA (opens in a new tab) | Tetracaine Hydrochloride tetracaine hydrochloride | REMEDYREPACK INC. | SOLUTION OPHTHALMIC | NDA | From |
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FDA drug shortages load here.
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.