Verapamil Hydrochloride

ANDA 200878, held by Apotex Corp. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 200878 (Verapamil Hydrochloride), held by Apotex Corp, was first approved by FDA on Apr 20, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 20, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 20, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Verapamil Hydrochloride120MG · tablet, extended release;oral	Verapamil Hydrochloride	Discontinued
Verapamil Hydrochloride180MG · tablet, extended release;oral	Verapamil Hydrochloride	Discontinued
Verapamil Hydrochloride240MG · tablet, extended release;oral	Verapamil Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 26, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Apr 20, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200878
Drugs@FDA: Overview at FDA
Company: Apotex

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