Verapamil Hydrochloride

ANDA 70225, held by Luitpold. Verapamil Hydrochloride.

As of Nov 15, 2026, ANDA 70225 (Verapamil Hydrochloride), held by Luitpold, was first approved by FDA on Nov 12, 1985, with 12 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 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 13 submissions, including labeling and manufacturing supplements


Feb 27, 1997	Supplement 13Manufacturing	Approved	None posted
Feb 27, 1997	Supplement 14Manufacturing	Approved	None posted
Dec 13, 1995	Supplement 12Labeling	Approved	None posted
May 28, 1993	Supplement 7Manufacturing	Approved	None posted
May 21, 1992	Supplement 11Labeling	Approved	None posted
Nov 20, 1990	Supplement 6Manufacturing	Approved	None posted
Nov 20, 1990	Supplement 8Manufacturing	Approved	None posted
Nov 20, 1990	Supplement 9Manufacturing	Approved	None posted
Nov 20, 1990	Supplement 10Manufacturing	Approved	None posted
Oct 13, 1988	Supplement 5Labeling	Approved	None posted
Mar 21, 1986	Supplement 1Manufacturing	Approved	None posted
Mar 21, 1986	Supplement 2Manufacturing	Approved	None posted
Nov 12, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70225
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