Verapamil Hydrochloride

ANDA 70617, held by Luitpold. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 70617 (Verapamil Hydrochloride), held by Luitpold, was first approved by FDA on Nov 12, 1985, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 12, 1985
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 12, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Verapamil Hydrochloride2.5MG/ML · injectable;injection	Verapamil Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Apr 19, 2002	Supplement 14Manufacturing	Approved	None posted
Aug 13, 1997	Supplement 13Manufacturing	Approved	None posted
Feb 27, 1997	Supplement 12Manufacturing	Approved	None posted
Feb 27, 1997	Supplement 11Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 10Manufacturing	Approved	None posted
Dec 13, 1995	Supplement 9Labeling	Approved	None posted
Jul 14, 1994	Supplement 8Manufacturing	Approved	None posted
May 28, 1993	Supplement 6Manufacturing	Approved	None posted
May 21, 1992	Supplement 7Labeling	Approved	None posted
Oct 13, 1988	Supplement 5Labeling	Approved	None posted
Jun 12, 1987	Supplement 4Labeling	Approved	None posted
Mar 21, 1986	Supplement 3Labeling	Approved	None posted
Mar 21, 1986	Supplement 2Manufacturing	Approved	None posted
Mar 21, 1986	Supplement 1Manufacturing	Approved	None posted
Nov 12, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70617
Drugs@FDA: Overview at FDA
Company: Luitpold 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