APPLICATION
ANDA074067
TYPE
ANDA
ORIGINAL APPROVAL
1992-11-05
LATEST ACTION
1999-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
1999-03-23Manufacturing (CMC) · Supplement 13AP
1998-06-11Manufacturing (CMC) · Supplement 12AP
1996-11-25Labeling · Supplement 11AP
1996-07-02Labeling · Supplement 10AP
1996-05-31Manufacturing (CMC) · Supplement 9AP
1995-12-13Labeling · Supplement 8AP
1995-04-25Labeling · Supplement 7AP
1994-08-08Manufacturing (CMC) · Supplement 4AP
1993-11-12Labeling · Supplement 6AP
1993-09-01Manufacturing (CMC) · Supplement 5AP
1993-09-01Manufacturing (CMC) · Supplement 3AP
1993-09-01Manufacturing (CMC) · Supplement 1AP
1993-09-01Labeling · Supplement 2AP
1992-11-05OriginalAP
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.