ANDA 219628, held by Sentiss Pharma. Atropine Sulfate.
As of Nov 15, 2026, ANDA 219628 (Atropine Sulfate), held by Sentiss Pharma, was first approved by FDA on Oct 16, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1% ยท 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
