← FDA DRUG APPROVALS

FDA NDA · NDA020062

CARDIZEM CD

diltiazem hydrochloride

Sponsor: BAUSCH

APPLICATION

NDA020062

TYPE

NDA

ORIGINAL APPROVAL

1991-12-27

LATEST ACTION

2025-04-16

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

CARDIZEM CD · ReferencePrescription

DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL

CARDIZEM CD · ReferencePrescription

DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL

CARDIZEM CD · ReferencePrescription

DILTIAZEM HYDROCHLORIDE 360MG · CAPSULE, EXTENDED RELEASE · ORAL

CARDIZEM CD · ReferencePrescription

DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL

CARDIZEM CD · ReferencePrescription

DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-04-16Labeling · Supplement 48 · standard — Label ↗AP

2020-03-26Labeling · Supplement 46 · standard — Letter ↗AP

2017-01-23Manufacturing (CMC) · Supplement 44 · standardAP

2016-11-18Labeling · Supplement 43 · standard — Letter ↗AP

2016-06-29Labeling · Supplement 42 · standard — Label ↗AP

2010-11-22Labeling · Supplement 40 · unknown — Label ↗AP

2003-03-21Labeling · Supplement 25 · standardAP

2001-06-04Manufacturing (CMC) · Supplement 33 · standardAP

2000-01-21Manufacturing (CMC) · Supplement 32 · standardAP

1999-12-03Manufacturing (CMC) · Supplement 31 · standardAP

1999-11-18Manufacturing (CMC) · Supplement 29 · standardAP

1999-10-19Manufacturing (CMC) · Supplement 30 · standardAP

1999-08-24Manufacturing (CMC) · Supplement 27 · standard — Review ↗AP

1999-04-29Manufacturing (CMC) · Supplement 28 · standardAP

1999-04-15Manufacturing (CMC) · Supplement 26 · standardAP

1998-04-07Manufacturing (CMC) · Supplement 24 · standardAP

1997-11-21Manufacturing (CMC) · Supplement 23 · standardAP

1997-08-06Manufacturing (CMC) · Supplement 22 · standardAP

1996-04-02Labeling · Supplement 21 · standardAP

1996-04-02Labeling · Supplement 19 · standardAP

1995-10-31Manufacturing (CMC) · Supplement 18 · standardAP

1995-09-25Manufacturing (CMC) · Supplement 13 · standardAP

1995-05-11Manufacturing (CMC) · Supplement 17 · standardAP

1995-05-04Manufacturing (CMC) · Supplement 15 · standardAP

1995-04-03Manufacturing (CMC) · Supplement 10 · standardAP

1994-11-22Manufacturing (CMC) · Supplement 16 · standardAP

1994-10-24Manufacturing (CMC) · Supplement 14 · standardAP

1994-09-28Manufacturing (CMC) · Supplement 12 · standardAP

1994-09-14Manufacturing (CMC) · Supplement 11 · standardAP

1994-05-05Manufacturing (CMC) · Supplement 9 · standardAP

1993-11-01Manufacturing (CMC) · Supplement 8 · standardAP

1993-10-06Labeling · Supplement 7 · standardAP

1993-06-29Manufacturing (CMC) · Supplement 6 · standardAP

1993-04-28Labeling · Supplement 5 · standardAP

1992-10-15Efficacy · Supplement 1AP

1992-09-18Manufacturing (CMC) · Supplement 4 · standardAP

1992-08-10Efficacy · Supplement 3AP

1992-08-04Manufacturing (CMC) · Supplement 2 · standardAP

1991-12-27Type 5 - New Formulation or New Manufacturer · Original · standardAP

VIEW ON DRUGS@FDA ↗

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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.

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