Propranolol Hydrochloride

Manages hypertension. ANDA 70690, held by Hikma. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70690 (Propranolol Hydrochloride), held by Hikma, was first approved by FDA on May 15, 1987, with 17 approved supplements and 0 published complete response letters.

First approved: May 15, 1987
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypertension Propranolol hydrochloride 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 is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride is 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 18 submissions below

Date	Submission	Status	Documents
May 15, 1987	Original application	Approved	None posted

Products

2 strengths and forms


Propranolol Hydrochloride40MG/5ML · solution;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride20MG/5ML · solution;oral	Propranolol Hydrochloride	Rx

All 18 submissions, including labeling and manufacturing supplements


Jun 16, 2017	Supplement 21Labeling · Standard review	Approved	None posted
Sep 10, 2008	Supplement 20Labeling	Approved	None posted
Jul 9, 2008	Supplement 19Labeling	Approved	None posted
Jun 21, 2007	Supplement 17Labeling	Approved	None posted
Jun 9, 2004	Supplement 14Labeling	Approved	None posted
Aug 1, 2001	Supplement 13Labeling	Approved	None posted
Aug 12, 1999	Supplement 11Manufacturing	Approved	None posted
Oct 23, 1998	Supplement 12Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Jan 5, 1994	Supplement 8Labeling	Approved	None posted
May 16, 1991	Supplement 7Labeling	Approved	None posted
Oct 9, 1990	Supplement 6Labeling	Approved	None posted
Apr 4, 1990	Supplement 5Labeling	Approved	None posted
Jan 8, 1990	Supplement 1Labeling	Approved	None posted
Sep 25, 1989	Supplement 4Manufacturing	Approved	None posted
Jan 24, 1989	Supplement 3Manufacturing	Approved	None posted
Jan 24, 1989	Supplement 2Manufacturing	Approved	None posted
May 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70690
Drugs@FDA: Overview at FDA
Company: Hikma

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