Propranolol Hydrochloride

Manages hypertension. ANDA 70221, held by Ph Health. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70221 (Propranolol Hydrochloride), held by Ph Health, was first approved by FDA on Apr 14, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 14, 1986
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, 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 tablets, USP are 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.

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 14, 1986	Original application	Approved	None posted

Products

5 strengths and forms


Propranolol Hydrochloride80MG · tablet;oral	Propranolol Hydrochloride	Rx
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

All 15 submissions, including labeling and manufacturing supplements


Jan 27, 2012	Supplement 23Labeling	Approved	None posted
Nov 13, 1991	Supplement 19Labeling	Approved	None posted
Feb 13, 1991	Supplement 18Labeling	Approved	None posted
Oct 2, 1989	Supplement 21Bioequivalence	Approved	None posted
Sep 6, 1989	Supplement 17Labeling	Approved	None posted
Jul 11, 1989	Supplement 15Labeling	Approved	None posted
Mar 7, 1988	Supplement 12Manufacturing	Approved	None posted
Feb 11, 1988	Supplement 3Manufacturing	Approved	None posted
Jan 4, 1988	Supplement 11Manufacturing	Approved	None posted
Jan 4, 1988	Supplement 10Manufacturing	Approved	None posted
Jul 22, 1987	Supplement 5Manufacturing	Approved	None posted
Jul 22, 1987	Supplement 4Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 2Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 1Manufacturing	Approved	None posted
Apr 14, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70221
Drugs@FDA: Overview at FDA
Company: PH Health

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