Manages hypertension. ANDA 219165, held by Pai Holdings. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 219165 (Propranolol Hydrochloride), held by Pai Holdings, was first approved by FDA on Jun 10, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Propranolol hydrochloride oral solution is 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 oral solution is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride oral solution is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propranolol Hydrochloride20MG/5ML · solution;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
