Cardizem Sr

NDA 19471, held by Biovail. Diltiazem Hydrochloride.

As of Nov 13, 2026, NDA 19471 (Cardizem Sr), held by Biovail, was first approved by FDA on Jan 23, 1989, with 27 approved supplements and 0 published complete response letters.

First approved: Jan 23, 1989
Review: Standard
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
Jan 23, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Cardizem Sr60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Diltiazem Hydrochloride	DiscontinuedReference drug
Cardizem Sr90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Diltiazem Hydrochloride	DiscontinuedReference drug
Cardizem Sr120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Diltiazem Hydrochloride	DiscontinuedReference drug
Cardizem Sr180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Diltiazem Hydrochloride	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements


Mar 21, 2003	Supplement 29Labeling · Standard review	Approved	None posted
Jun 4, 2001	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 6, 1999	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 3, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 20, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 5, 1997	Supplement 26Manufacturing · Standard review	Approved	None posted
May 28, 1996	Supplement 24Labeling · Standard review	Approved	None posted
May 16, 1996	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 3, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 17, 1995	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 14, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 14, 1994	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 18, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 15, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 2, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 1, 1993	Supplement 15Labeling · Standard review	Approved	None posted
Oct 22, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 22, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 1, 1992	Supplement 10Labeling · Standard review	Approved	None posted
Jun 13, 1991	Supplement 11Labeling · Standard review	Approved	None posted
May 3, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 7, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 14, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 16, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 27, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 23, 1990	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 8, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 23, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19471
Drugs@FDA: Overview at FDA
Company: Biovail

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