ANDA 209415, held by Chartwell Rx. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 209415 (Trientine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 16, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trientine Hydrochloride250MG ยท capsule;oral | Trientine 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
