Verapamil Hydrochloride

ANDA 72124, held by Pliva. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 72124 (Verapamil Hydrochloride), held by Pliva, was first approved by FDA on Jan 26, 1989, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1989
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 26, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Verapamil Hydrochloride80MG · tablet;oral	Verapamil Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jul 7, 2000	Supplement 8Manufacturing	Approved	None posted
Aug 5, 1998	Supplement 7Labeling	Approved	None posted
May 11, 1994	Supplement 5Manufacturing	Approved	None posted
Sep 8, 1992	Supplement 4Labeling	Approved	None posted
Apr 6, 1992	Supplement 3Labeling	Approved	None posted
Feb 10, 1992	Supplement 2Manufacturing	Approved	None posted
Dec 12, 1991	Supplement 1Labeling	Approved	None posted
Jan 26, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72124
Drugs@FDA: Overview at FDA
Company: PLIVA

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