Verapamil Hydrochloride

Treats hypertension. ANDA 75138, held by Mylan. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 75138 (Verapamil Hydrochloride), held by Mylan, was first approved by FDA on Apr 20, 1999, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 20, 1999
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 20, 1999	Original application	Approved	Label Letter Review

Products

3 strengths and forms


Verapamil Hydrochloride120MG · capsule, extended release;oral	Verapamil Hydrochloride	Rx
Verapamil Hydrochloride180MG · capsule, extended release;oral	Verapamil Hydrochloride	Rx
Verapamil Hydrochloride240MG · capsule, extended release;oral	Verapamil Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Mar 2, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Sep 27, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Oct 27, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Oct 27, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Aug 12, 2010	Supplement 12Labeling	Approved	None posted
Dec 3, 2009	Supplement 11Labeling	Approved	None posted
Mar 30, 2001	Supplement 3Labeling	Approved	None posted
Feb 9, 2000	Supplement 2Labeling	Approved	None posted
Nov 4, 1999	Supplement 1Labeling	Approved	None posted
Apr 20, 1999	Original application	Approved	Label Letter Review

Identifiers

Application: ANDA 75138
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