Verelan Pm

Treats hypertension. NDA 20943, held by Azurity. Verapamil Hydrochloride.

As of Nov 13, 2026, NDA 20943 (Verelan Pm), held by Azurity, was first approved by FDA on Nov 25, 1998, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1998
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Verapamil Hydrochloride Extended-release Capsules (PM) for oral use is 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 16 submissions below

Date	Submission	Status	Documents
Nov 25, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Verelan Pm100MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug
Verelan Pm200MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug
Verelan Pm300MG · capsule, extended release;oral	Verapamil Hydrochloride	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Oct 3, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Nov 18, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
Oct 14, 2014	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 14, 2011	Supplement 28Labeling	Approved	Letter Label
Apr 1, 2010	Supplement 7Labeling · Standard review	Approved	Label Letter
Apr 1, 2010	Supplement 26Labeling	Approved	Letter Label
Dec 16, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
May 1, 2007	Supplement 20Labeling · Standard review	Approved	Letter
May 5, 2004	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 26, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 29, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 27, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 2, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 4, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Nov 25, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20943
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