APPLICATION
NDA020092
TYPE
NDA
ORIGINAL APPROVAL
1992-05-29
LATEST ACTION
2011-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DILACOR XR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
DILACOR XR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
DILACOR XR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2001-08-07Manufacturing (CMC) · Supplement 14 · standardAP
1998-10-28Manufacturing (CMC) · Supplement 11 · standardAP
1997-06-19Labeling · Supplement 3 · standardAP
1996-03-20Manufacturing (CMC) · Supplement 10 · standardAP
1995-10-31Manufacturing (CMC) · Supplement 9 · standardAP
1995-03-02Efficacy · Supplement 5 · standardAP
1995-02-09Manufacturing (CMC) · Supplement 7 · standardAP
1995-02-09Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-02Manufacturing (CMC) · Supplement 8 · standardAP
1993-12-06Labeling · Supplement 4 · standardAP
1992-10-15Labeling · Supplement 2 · standardAP
1992-10-02Labeling · Supplement 1 · standardAP
1992-05-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.