Propranolol Hydrochloride

Manages hypertension. ANDA 70177, held by Watson Labs. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70177 (Propranolol Hydrochloride), held by Watson Labs, was first approved by FDA on May 13, 1986, with 19 approved supplements and 0 published complete response letters.

First approved: May 13, 1986
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets, USP 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, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets, USP 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 20 submissions below

Date	Submission	Status	Documents
May 13, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride40MG · tablet;oral	Propranolol Hydrochloride	Rx

All 20 submissions, including labeling and manufacturing supplements


May 18, 2015	Supplement 49Labeling · Standard review	Approved	None posted
Jul 14, 2008	Supplement 36Labeling	Approved	None posted
May 3, 2005	Supplement 29Labeling	Approved	None posted
Jun 27, 2002	Supplement 25Labeling	Approved	None posted
Apr 25, 2001	Supplement 24Manufacturing	Approved	None posted
Oct 28, 1999	Supplement 23Labeling	Approved	None posted
Sep 8, 1998	Supplement 21Labeling	Approved	None posted
Feb 18, 1993	Supplement 19Labeling	Approved	None posted
Aug 7, 1991	Supplement 12Manufacturing	Approved	None posted
Jun 21, 1991	Supplement 16Labeling	Approved	None posted
Mar 21, 1991	Supplement 15Labeling	Approved	None posted
Jan 28, 1991	Supplement 13Manufacturing	Approved	None posted
May 8, 1989	Supplement 11Labeling	Approved	None posted
May 8, 1989	Supplement 7Labeling	Approved	None posted
Dec 22, 1988	Supplement 8Manufacturing	Approved	None posted
Jun 29, 1988	Supplement 10Manufacturing	Approved	None posted
Jun 29, 1988	Supplement 9Manufacturing	Approved	None posted
Mar 25, 1988	Supplement 6Manufacturing	Approved	None posted
Dec 22, 1987	Supplement 4Manufacturing	Approved	None posted
May 13, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70177
Drugs@FDA: Overview at FDA
Company: Watson 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