Treats Wilson's disease. ANDA 211251, held by Navinta LLC. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 211251 (Trientine Hydrochloride), held by Navinta LLC, was first approved by FDA on Jan 16, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Trientine Hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with Trientine Hydrochloride Capsule 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 Capsule and penicillamine cannot be considered interchangeable. Trientine hydrochloride Capsule should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2019 | 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
