Manages hypertension. ANDA 78955, held by Ipca Labs Ltd. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 78955 (Propranolol Hydrochloride), held by Ipca Labs Ltd, was first approved by FDA on Jun 2, 2008, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are 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 |
|---|---|---|---|
| Jun 2, 2008 | 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 |
| Jan 27, 2012 | Supplement 4Labeling | Approved | None posted |
| Jun 2, 2008 | 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
