ANDA 204180, held by Chartwell Rx. Amiloride Hydrochloride.
As of Nov 15, 2026, ANDA 204180 (Amiloride Hydrochloride), held by Chartwell Rx, was first approved by FDA on Aug 7, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amiloride Hydrochloride5MG ยท tablet;oral | Amiloride Hydrochloride | Discontinued |
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
