← FDA DRUG APPROVALS

FDA NDA · NDA021392

CARDIZEM LA

diltiazem hydrochloride

Sponsor: BAUSCH

APPLICATION
NDA021392
TYPE
NDA
ORIGINAL APPROVAL
2003-02-06
LATEST ACTION
2025-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 420MG · TABLET, EXTENDED RELEASE · ORAL
CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 180MG · TABLET, EXTENDED RELEASE · ORAL
CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 360MG · TABLET, EXTENDED RELEASE · ORAL
CARDIZEM LA · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-04-16Labeling · Supplement 28 · standard — Label ↗AP
2025-04-16Labeling · Supplement 25 · standard — Label ↗AP
2016-11-18Labeling · Supplement 20 · standard — Letter ↗AP
2015-03-23Labeling · Supplement 19 · standard — Label ↗AP
2010-11-23Labeling · Supplement 14 · unknown — Letter ↗AP
2007-04-27Labeling · Supplement 10 · standard — Letter ↗AP
2004-04-02Efficacy · Supplement 2 · standard — Label ↗AP
2003-02-06Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →