ANDA 210619, held by Amneal. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 210619 (Trientine Hydrochloride), held by Amneal, was first approved by FDA on Feb 8, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 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
