Treats pheochromocytoma. ANDA 213734, held by Amneal. Metyrosine.
As of Nov 15, 2026, ANDA 213734 (Metyrosine), held by Amneal, was first approved by FDA on Jul 24, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery. 2. Management of patients when surgery is contraindicated. 3. Chronic treatment of patients with malignant pheochromocytoma. Metyrosine capsules are not recommended for the control of essential hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metyrosine250MG · capsule;oral | Metyrosine | 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
