Verapamil Hydrochloride

ANDA 71881, held by Heritage. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 71881 (Verapamil Hydrochloride), held by Heritage, was first approved by FDA on Apr 5, 1988, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 5, 1988
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Verapamil hydrochloride tablets, USP are indicated for the treatment of the following: Angina 1. Angina at rest including: - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension Verapamil hydrochloride is indicated for the treatment of hypertension, to lower blood pressure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 5, 1988	Original application	Approved	None posted

Products

3 strengths and forms


Verapamil Hydrochloride120MG · tablet;oral	Verapamil Hydrochloride	Rx
Verapamil Hydrochloride40MG · tablet;oral	Verapamil Hydrochloride	Rx
Verapamil Hydrochloride80MG · tablet;oral	Verapamil Hydrochloride	Rx

All 9 submissions, including labeling and manufacturing supplements


Nov 17, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Nov 17, 2017	Supplement 14Labeling · Standard review	Approved	None posted
Apr 18, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Oct 14, 2015	Supplement 5Manufacturing	Approved	Letter
Nov 29, 2011	Supplement 8Labeling	Approved	None posted
Jul 29, 2011	Supplement 6Labeling	Approved	None posted
Jan 10, 1992	Supplement 3Labeling	Approved	None posted
Jun 19, 1990	Supplement 1Labeling	Approved	None posted
Apr 5, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71881
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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