Verelan

Treats hypertension. NDA 19614, held by Azurity. Verapamil Hydrochloride.

As of Nov 14, 2026, NDA 19614 (Verelan), held by Azurity, was first approved by FDA on May 29, 1990, with 34 approved supplements and 0 published complete response letters.

First approved: May 29, 1990
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Verapamil hydrochloride sustained-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 35 submissions below

Date	Submission	Status	Documents
May 29, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Verelan120MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug
Verelan240MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug
Verelan180MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug
Verelan360MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Oct 1, 2019	Supplement 56Labeling · Standard review	Approved	Letter Label
Nov 18, 2016	Supplement 53Labeling · Standard review	Approved	Letter Label
Oct 9, 2014	Supplement 50Labeling	Approved	Label Letter
Nov 14, 2011	Supplement 49Labeling	Approved	Letter Label
Mar 30, 2010	Supplement 45Labeling	Approved	Label Letter
Mar 30, 2010	Supplement 34Labeling · Standard review	Approved	Letter
Nov 29, 2000	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 27, 2000	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 2, 1999	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 5, 1999	Supplement 27Labeling · Standard review	Approved	None posted
Oct 15, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 14, 1998	Supplement 24Labeling · Standard review	Approved	None posted
Dec 30, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Supplement 25Labeling · Standard review	Approved	None posted
Apr 23, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
May 16, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
May 10, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 1, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 2, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 21, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Oct 12, 1994	Supplement 6Labeling	Approved	None posted
Aug 18, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 5, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 30, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 6, 1993	Supplement 9Labeling · Standard review	Approved	None posted
Nov 8, 1993	Supplement 12Labeling · Standard review	Approved	None posted
Oct 2, 1992	Supplement 8Labeling	Approved	None posted
Oct 2, 1992	Supplement 7Labeling	Approved	None posted
Jan 9, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 13, 1991	Supplement 5Labeling	Approved	None posted
Jun 6, 1991	Supplement 4Labeling	Approved	None posted
May 29, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19614
Drugs@FDA: Overview at FDA
Company: Azurity 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