Verapamil Hydrochloride

ANDA 70995, held by Watson Labs. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 70995 (Verapamil Hydrochloride), held by Watson Labs, was first approved by FDA on Oct 1, 1986, with 22 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1986
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Verapamil Hydrochloride Tablets 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 1. 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 ) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension: Verapamil 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 23 submissions below

Date	Submission	Status	Documents
Oct 1, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Verapamil Hydrochloride80MG · tablet;oral	Verapamil Hydrochloride	Rx

All 23 submissions, including labeling and manufacturing supplements


Oct 26, 2015	Supplement 35Labeling · Standard review	Approved	None posted
Nov 26, 2012	Supplement 34Labeling · Standard review	Approved	None posted
Apr 12, 2007	Supplement 27Manufacturing	Approved	None posted
Nov 7, 2002	Supplement 25Manufacturing	Approved	None posted
Jun 25, 2002	Supplement 24Manufacturing	Approved	None posted
May 21, 2002	Supplement 22Manufacturing	Approved	None posted
Aug 31, 2001	Supplement 21Manufacturing	Approved	None posted
Nov 10, 1999	Supplement 20Manufacturing	Approved	None posted
Aug 26, 1998	Supplement 19Labeling	Approved	None posted
Apr 10, 1996	Supplement 18Labeling	Approved	None posted
Oct 25, 1993	Supplement 11Labeling	Approved	None posted
Oct 25, 1993	Supplement 10Manufacturing	Approved	None posted
Jun 25, 1993	Supplement 16Manufacturing	Approved	None posted
Jun 25, 1993	Supplement 15Labeling	Approved	None posted
Jun 25, 1993	Supplement 14Manufacturing	Approved	None posted
Dec 2, 1992	Supplement 17Labeling	Approved	None posted
Feb 5, 1991	Supplement 13Labeling	Approved	None posted
Nov 13, 1989	Supplement 5Labeling	Approved	None posted
Mar 3, 1987	Supplement 4Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 3Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 2Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 1Manufacturing	Approved	None posted
Oct 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70995
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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