Cardizem La

Treats hypertension. NDA 21392, held by Bausch. Diltiazem Hydrochloride.

As of Nov 14, 2026, NDA 21392 (Cardizem La), held by Bausch, was first approved by FDA on Feb 6, 2003, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 6, 2003
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for:

treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives.
improving exercise tolerance in patients with chronic stable angina. 1.1 Hypertension CARDIZEM LA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Apr 2, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 6, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label

Products

6 strengths and forms


Cardizem La120MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug
Cardizem La180MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug
Cardizem La240MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug
Cardizem La300MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug
Cardizem La360MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug
Cardizem La420MG · tablet, extended release;oral	Diltiazem Hydrochloride	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 16, 2025	Supplement 25Labeling · Standard review	Approved	Label
Apr 16, 2025	Supplement 28Labeling · Standard review	Approved	Label
Nov 18, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 23, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 23, 2010	Supplement 14Labeling	Approved	Letter Label
Apr 27, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 2, 2004	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 6, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label

Identifiers

Application: NDA 21392
Drugs@FDA: Overview at FDA
Company: Bausch Health

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