Verapamil Hydrochloride

Controls rapid ventricular rate in atrial flutter or atrial fibrillation except. ANDA 75136, held by Hospira. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 75136 (Verapamil Hydrochloride), held by Hospira, was first approved by FDA on Oct 20, 1998, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1998
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications & Usage Verapamil Hydrochloride Injection, USP is indicated for the following:

Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 20, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Verapamil Hydrochloride10MG/4ML (2.5MG/ML) · solution;intravenous	Verapamil Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 20, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Dec 20, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Oct 20, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75136
Drugs@FDA: Overview at FDA
Company: Hospira

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