Verapamil Hydrochloride

Treats supraventricular tachyarrhythmias. NDA 18925, held by Exela Pharma. Verapamil Hydrochloride.

As of Nov 13, 2026, NDA 18925 (Verapamil Hydrochloride), held by Exela Pharma, was first approved by FDA on Mar 30, 1984, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1984
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 30, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Verapamil Hydrochloride5MG/2ML (2.5MG/ML) · solution;intravenous	Verapamil Hydrochloride	Rx
Verapamil Hydrochloride10MG/4ML (2.5MG/ML) · solution;intravenous	Verapamil Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Nov 18, 2016	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 8, 2016	Supplement 9Manufacturing	Approved	None posted
Nov 2, 2011	Supplement 8Labeling	Approved	Letter Label
Apr 13, 2010	Supplement 7Labeling	Approved	Letter Label
Oct 25, 1988	Supplement 6Labeling	Approved	None posted
Sep 16, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 15, 1986	Supplement 3Labeling	Approved	None posted
Sep 15, 1986	Supplement 5Labeling	Approved	None posted
Feb 21, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 10, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 30, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18925
Drugs@FDA: Overview at FDA
Company: Exela Pharma Sciences

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