Manages hypertension. ANDA 212026, held by Amta. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 212026 (Propranolol Hydrochloride), held by Amta, was first approved by FDA on Jan 6, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol Hydrochloride Extended-Release Capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol Hydrochloride Extended-Release Capsules are indicated for the prophylaxis of common migraine headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 6, 2020 | Original application | Approved | None posted |
| Propranolol Hydrochloride60MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride80MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride120MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride160MG · capsule, extended release;oral | Propranolol Hydrochloride | Rx |
| Jul 11, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 6, 2020 | Original application | Approved | None posted |
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
