← FDA DRUG APPROVALS

FDA NDA · NDA020027

CARDIZEM

Sponsor: BIOVAIL LABS INTL

APPLICATION
NDA020027
TYPE
NDA
ORIGINAL APPROVAL
1991-10-24
LATEST ACTION
2004-12-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CARDIZEM · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CARDIZEM · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2004-12-21Labeling · Supplement 19 · standard — Letter ↗AP
2001-06-04Manufacturing (CMC) · Supplement 20 · standardAP
1998-02-05Manufacturing (CMC) · Supplement 18 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 17 · standardAP
1997-09-02Manufacturing (CMC) · Supplement 16 · standardAP
1997-08-05Manufacturing (CMC) · Supplement 15 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 14 · standardAP
1996-06-04Manufacturing (CMC) · Supplement 12 · standardAP
1996-05-28Manufacturing (CMC) · Supplement 13 · standardAP
1996-04-02Labeling · Supplement 9 · standardAP
1996-04-02Labeling · Supplement 11 · standardAP
1996-01-04Manufacturing (CMC) · Supplement 10 · standardAP
1995-10-24Manufacturing (CMC) · Supplement 8 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 6 · standardAP
1995-01-12Manufacturing (CMC) · Supplement 7 · standardAP
1994-09-28Manufacturing (CMC) · Supplement 5 · standardAP
1994-08-15Manufacturing (CMC) · Supplement 4 · standardAP
1994-05-24Manufacturing (CMC) · Supplement 2 · standardAP
1993-04-28Labeling · Supplement 3 · standardAP
1992-04-01Labeling · Supplement 1 · standardAP
1991-10-24Type 3 - New Dosage Form · Original · standardAP
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 →