Cardizem

NDA 20027, held by Biovail Labs Intl. Diltiazem Hydrochloride.

As of Nov 14, 2026, NDA 20027 (Cardizem), held by Biovail Labs Intl, was first approved by FDA on Oct 24, 1991, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1991
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 24, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Cardizem5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Diltiazem Hydrochloride	DiscontinuedReference drug
Cardizem25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Diltiazem Hydrochloride	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Dec 21, 2004	Supplement 19Labeling · Standard review	Approved	Letter
Jun 4, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 5, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 20, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 2, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 5, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 14, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 4, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
May 28, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 2, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Apr 2, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Jan 4, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 24, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 12, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 28, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 15, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
May 24, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 28, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Apr 1, 1992	Supplement 1Labeling · Standard review	Approved	None posted
Oct 24, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20027
Drugs@FDA: Overview at FDA
Company: Biovail Laboratories International

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