Verapamil Hydrochloride

ANDA 72751, held by Pliva. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 72751 (Verapamil Hydrochloride), held by Pliva, was first approved by FDA on Feb 23, 1996, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 23, 1996
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 23, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Verapamil Hydrochloride40MG · tablet;oral	Verapamil Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 7, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 5, 1998	Supplement 1Labeling	Approved	None posted
Feb 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 72751
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