ANDA 215624, held by Apotex. Atropine Sulfate.
As of Nov 15, 2026, ANDA 215624 (Atropine Sulfate), held by Apotex, was first approved by FDA on Nov 26, 2021, with 1 approved supplement and 0 published complete response letters.
1. INDICATIONS AND USAGE Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three months and older for: Atropine is an anticholinergic agent
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% · solution/drops;ophthalmic | Atropine Sulfate | Rx |
| Mar 9, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 26, 2021 | Original application | Approved |
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
