ISOPTO ATROPINE
NDA 208151 · New Drug Application (NDA) Prescription
ATROPINE SULFATE
- 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 | ISOPTO ATROPINE ATROPINE SULFATE | SOLUTION/DROPS;OPHTHALMIC 1% | Prescription | AT2 | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 3 | Approved | n/a | Manufacturing (CMC) | 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
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.
atropine sulfate
ATROPINE SULFATE · Alcon Laboratories, Inc. · OPHTHALMIC · Version 8 · effective
Indications and usage
1 INDICATIONS AND USAGE Atropine Sulfate Ophthalmic Solution, 1% is indicated for: Atropine Sulfate Ophthalmic Solution, 1% is a muscarinic antagonist indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia
Full label on DailyMed for atropine sulfate (opens in a new tab)
Isopto Atropine
ATROPINE SULFATE · Alcon Laboratories, Inc. · OPHTHALMIC · Version 8 · effective
Indications and usage
1 INDICATIONS AND USAGE ISOPTO ® Atropine 1% is indicated for: ISOPTO® Atropine 1% is a muscarinic antagonist indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia
Full label on DailyMed for Isopto Atropine (opens in a new tab)
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0065-0303 in openFDA (opens in a new tab) | Isopto Atropine atropine sulfate | Alcon Laboratories, Inc. | SOLUTION OPHTHALMIC | NDA | From |
| 0065-0817 in openFDA (opens in a new tab) | atropine sulfate atropine sulfate | Alcon Laboratories, 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.