ANDA 214752, held by Amneal. Atropine Sulfate.
As of Nov 15, 2026, ANDA 214752 (Atropine Sulfate), held by Amneal, was first approved by FDA on Jul 14, 2022, 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 |
|---|---|---|---|
| Jul 14, 2022 | Original application | Approved |
| 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
