Verapamil Hydrochloride

ANDA 74587, held by Rising. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 74587 (Verapamil Hydrochloride), held by Rising, was first approved by FDA on Mar 23, 1996, with 27 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1996
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

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

Products

3 strengths and forms


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

All 28 submissions, including labeling and manufacturing supplements


May 18, 2020	Supplement 42Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 40Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 39Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 36Labeling · Standard review	Approved	None posted
Jul 31, 2010	Supplement 33Labeling	Approved	None posted
Mar 15, 2010	Supplement 32Labeling	Approved	None posted
Mar 21, 2008	Supplement 25Labeling	Approved	None posted
Jul 25, 2002	Supplement 19Manufacturing	Approved	None posted
Feb 8, 2002	Supplement 18Labeling	Approved	None posted
Mar 30, 2001	Supplement 17Labeling	Approved	None posted
Oct 5, 2000	Supplement 16Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 15Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 13Manufacturing	Approved	None posted
Aug 7, 2000	Supplement 14Labeling	Approved	None posted
May 18, 1998	Supplement 12Manufacturing	Approved	None posted
Sep 19, 1997	Supplement 11Labeling	Approved	None posted
Sep 19, 1997	Supplement 10Manufacturing	Approved	None posted
Sep 19, 1997	Supplement 9Manufacturing	Approved	None posted
Sep 19, 1997	Supplement 8Manufacturing	Approved	None posted
Sep 19, 1997	Supplement 7Manufacturing	Approved	None posted
Feb 21, 1997	Supplement 6Labeling	Approved	None posted
Feb 21, 1997	Supplement 5Manufacturing	Approved	None posted
Feb 21, 1997	Supplement 4Manufacturing	Approved	None posted
Feb 21, 1997	Supplement 3Manufacturing	Approved	None posted
Feb 21, 1997	Supplement 1Manufacturing	Approved	None posted
Nov 15, 1996	Supplement 2Manufacturing	Approved	None posted
Mar 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74587
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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