Treats amblyopia 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy eye in the…. ANDA 218148, held by Mankind Pharma. Atropine Sulfate.
As of Nov 15, 2026, ANDA 218148 (Atropine Sulfate), held by Mankind Pharma, was first approved by FDA on Jan 8, 2024, with 1 approved supplement and 0 published complete response letters.
Atropine Sulfate Ophthalmic Solution 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Cycloplegia Mydriasis Penalization of the healthy eye in the treatment of amblyopia 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy eye in the treatment of amblyopia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% · solution/drops;ophthalmic | Atropine Sulfate | Rx |
| May 7, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 8, 2024 | Original application | Approved | None posted |
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
