Treats pheochromocytoma. ANDA 204551, held by Rising. Phenoxybenzamine Hydrochloride.
As of Nov 15, 2026, ANDA 204551 (Phenoxybenzamine Hydrochloride), held by Rising, was first approved by FDA on Jun 20, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Phenoxybenzamine Hydrochloride Capsule, USP is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phenoxybenzamine Hydrochloride10MG · capsule;oral | Phenoxybenzamine 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
