Manages hypertension. ANDA 216663, held by Mankind Pharma. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 216663 (Propranolol Hydrochloride), held by Mankind Pharma, was first approved by FDA on Jan 27, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets 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 is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2026 | Original application | Approved | None posted |
| Propranolol Hydrochloride10MG · tablet;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride20MG · tablet;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride40MG · tablet;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride60MG · tablet;oral | Propranolol Hydrochloride | Rx |
| Propranolol Hydrochloride80MG · tablet;oral | Propranolol 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
