Propranolol Hydrochloride

Manages hypertension. ANDA 71972, held by Impax Labs Inc. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 71972 (Propranolol Hydrochloride), held by Impax Labs Inc, was first approved by FDA on Apr 6, 1988, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 6, 1988
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Apr 6, 1988	Original application	Approved	None posted

Products

3 strengths and forms


Propranolol Hydrochloride10MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride20MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride40MG · tablet;oral	Propranolol Hydrochloride	Rx

All 15 submissions, including labeling and manufacturing supplements


Jan 22, 2015	Supplement 32Manufacturing	Approved	None posted
Dec 9, 2014	Supplement 29Labeling	Approved	None posted
Mar 20, 2008	Supplement 23Labeling	Approved	None posted
Jan 7, 2008	Supplement 24Labeling	Approved	None posted
May 24, 2002	Supplement 11Labeling	Approved	None posted
Jun 8, 2001	Supplement 10Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 9Manufacturing	Approved	None posted
Nov 22, 1999	Supplement 8Labeling	Approved	None posted
Jun 10, 1999	Supplement 7Labeling	Approved	None posted
Oct 20, 1998	Supplement 6Labeling	Approved	None posted
May 11, 1994	Supplement 5Manufacturing	Approved	None posted
Apr 23, 1992	Supplement 4Labeling	Approved	None posted
Oct 24, 1991	Supplement 3Labeling	Approved	None posted
Aug 30, 1988	Supplement 1Manufacturing	Approved	None posted
Apr 6, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71972
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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