ANDA 209731, held by Chartwell Rx. Trientine Hydrochloride.
As of Nov 15, 2026, ANDA 209731 (Clovique), held by Chartwell Rx, was first approved by FDA on Oct 21, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clovique250MG 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
