NDA 206289, held by Rising. Atropine Sulfate.
As of Nov 13, 2026, NDA 206289 (Atropine Sulfate), held by Rising, was first approved by FDA on Jul 18, 2014, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2014 | Original applicationTYPE 7 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% · solution/drops;ophthalmic | Atropine Sulfate | RxReference drug |
| Sep 18, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Mar 18, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Jul 18, 2014 | Original applicationTYPE 7 · Priority review | 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
