ANDA 209921, held by Ani Pharms. Penicillamine.
As of Nov 15, 2026, ANDA 209921 (Luxzyla), held by Ani Pharms, was first approved by FDA on May 7, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Luxzyla250MG · capsule;oral | Penicillamine | Discontinued |
| Aug 27, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 7, 2019 | Original application | Approved |
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
