Propranolol Hydrochloride

Manages hypertension. ANDA 70322, held by Innogenix. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70322 (Propranolol Hydrochloride), held by Innogenix, was first approved by FDA on Aug 4, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 4, 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. They 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
Aug 4, 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


Dec 1, 1998	Supplement 18Manufacturing	Approved	None posted
Aug 4, 1998	Supplement 19Labeling	Approved	None posted
Dec 23, 1994	Supplement 17Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 15Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 13Manufacturing	Approved	None posted
Aug 19, 1991	Supplement 12Manufacturing	Approved	None posted
Jun 26, 1991	Supplement 11Labeling	Approved	None posted
Sep 7, 1989	Supplement 10Manufacturing	Approved	None posted
Aug 16, 1988	Supplement 8Labeling	Approved	None posted
Dec 23, 1987	Supplement 7Manufacturing	Approved	None posted
Dec 23, 1987	Supplement 5Manufacturing	Approved	None posted
Dec 23, 1987	Supplement 4Manufacturing	Approved	None posted
Mar 31, 1987	Supplement 2Manufacturing	Approved	None posted
Aug 4, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70322
Drugs@FDA: Overview at FDA
Company: Innogenix

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