Treats amblyopia 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the Healthy Eye. NDA 213581, held by Bausch And Lomb Inc. Atropine Sulfate.
As of Nov 13, 2026, NDA 213581 (Atropine Sulfate), held by Bausch And Lomb Inc, was first approved by FDA on Mar 15, 2022, with 0 approved supplements and 0 published complete response letters.
Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Mydriasis Cycloplegia Penalization of the healthy eye in the treatment of amblyopia 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% · solution/drops;ophthalmic | Atropine Sulfate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
