Propranolol Hydrochloride

Manages hypertension. ANDA 70213, held by Mylan. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70213 (Propranolol Hydrochloride), held by Mylan, was first approved by FDA on Nov 19, 1985, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1985
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 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 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.

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
Nov 19, 1985	Original application	Approved	None posted

Products

5 strengths and forms


Propranolol Hydrochloride40MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride10MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride20MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride80MG · tablet;oral	Propranolol Hydrochloride	Rx
Propranolol Hydrochloride60MG · tablet;oral	Propranolol Hydrochloride	Rx

All 20 submissions, including labeling and manufacturing supplements


Jun 7, 2021	Supplement 36Labeling · Standard review	Approved	None posted
Nov 5, 2004	Supplement 23Labeling	Approved	None posted
Apr 3, 2002	Supplement 20Labeling	Approved	None posted
Nov 24, 1999	Supplement 19Labeling	Approved	None posted
Aug 10, 1998	Supplement 18Labeling	Approved	None posted
Feb 25, 1998	Supplement 17Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 16Manufacturing	Approved	None posted
Nov 16, 1993	Supplement 15Manufacturing	Approved	None posted
Jan 2, 1992	Supplement 13Manufacturing	Approved	None posted
Jul 16, 1991	Supplement 12Labeling	Approved	None posted
Aug 23, 1990	Supplement 11Labeling	Approved	None posted
May 11, 1990	Supplement 10Labeling	Approved	None posted
Aug 7, 1989	Supplement 9Manufacturing	Approved	None posted
Aug 7, 1989	Supplement 7Manufacturing	Approved	None posted
Jun 12, 1989	Supplement 49Labeling	Approved	None posted
Jun 12, 1989	Supplement 8Labeling	Approved	None posted
Jun 1, 1989	Supplement 6Labeling	Approved	None posted
Feb 20, 1987	Supplement 3Manufacturing	Approved	None posted
Jun 19, 1986	Supplement 1Manufacturing	Approved	None posted
Nov 19, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70213
Drugs@FDA: Overview at FDA
Company: Mylan

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