← FDA DRUG APPROVALS

FDA NDA · NDA020401

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE

diltiazem hydrochloride

Sponsor: BAUSCH

APPLICATION
NDA020401
TYPE
NDA
ORIGINAL APPROVAL
1995-09-11
LATEST ACTION
2025-04-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 420MG · CAPSULE, EXTENDED RELEASE · ORAL
TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
TIAZAC · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 360MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-04-16Labeling · Supplement 44 · standard — Label ↗AP
2016-11-18Labeling · Supplement 42 · standard — Letter ↗AP
2015-11-20Manufacturing (CMC) · Supplement 41 · standardAP
2010-11-22Labeling · Supplement 36 · unknown — Letter ↗AP
2007-06-21Labeling · Supplement 34 · standard — Letter ↗AP
2002-10-03Manufacturing (CMC) · Supplement 25 · standardAP
2001-11-26Manufacturing (CMC) · Supplement 23 · standardAP
2001-09-24Manufacturing (CMC) · Supplement 22 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 20 · standardAP
2000-11-29Manufacturing (CMC) · Supplement 21 · standardAP
2000-04-05Labeling · Supplement 15 · standardAP
2000-03-24Labeling · Supplement 19 · standard — Review ↗AP
2000-02-17Manufacturing (CMC) · Supplement 18 · standardAP
1999-10-13Manufacturing (CMC) · Supplement 16 · standardAP
1999-02-17Manufacturing (CMC) · Supplement 14 · standardAP
1999-01-28Manufacturing (CMC) · Supplement 12 · standardAP
1998-10-16Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP
1998-01-30Efficacy · Supplement 7 · standard — Review ↗AP
1997-10-01Labeling · Supplement 6 · standardAP
1997-09-22Manufacturing (CMC) · Supplement 10 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 9 · standardAP
1997-09-03Manufacturing (CMC) · Supplement 8 · standardAP
1997-08-14Manufacturing (CMC) · Supplement 11 · standardAP
1997-03-14Manufacturing (CMC) · Supplement 4 · standardAP
1996-07-23Manufacturing (CMC) · Supplement 1 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 5 · standardAP
1996-05-29Manufacturing (CMC) · Supplement 2 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 3 · standardAP
1995-09-11Type 3 - New Dosage Form · Original · standardAP
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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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