Treats Wilson’s disease. ANDA 216356, held by Hetero Labs Ltd Iii. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 216356 (Trientine Hydrochloride), held by Hetero Labs Ltd Iii, was first approved by FDA on Jun 23, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules are limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient’s dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trientine Hydrochloride250MG · 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
