Treats Wilson's disease. ANDA 211076, held by Dr Reddys. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 211076 (Trientine Hydrochloride), held by Dr Reddys, was first approved by FDA on Jul 3, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND 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 is 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 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 |
|---|---|---|---|
| Jul 3, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trientine Hydrochloride250MG · capsule;oral | Trientine Hydrochloride | Rx |
| Apr 9, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 3, 2019 | Original application | Approved | None posted |
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
