ANDA 219013, held by Edenbridge Pharms. Atropine Sulfate.
As of Nov 15, 2026, ANDA 219013 (Atropine Sulfate), held by Edenbridge Pharms, was first approved by FDA on Apr 15, 2026, with 0 approved supplements and 0 published complete response letters.
Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three months and older for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% · solution/drops;ophthalmic | Atropine Sulfate | Rx |
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
