ANDA 211554, held by Zydus Pharms. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 211554 (Trientine Hydrochloride), held by Zydus Pharms, was first approved by FDA on Apr 26, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trientine Hydrochloride250MG ยท capsule;oral | Trientine Hydrochloride | 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
