← FDA DRUG APPROVALS

FDA ANDA · ANDA074752

CARTIA XT

diltiazem hydrochloride

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA074752
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-09
LATEST ACTION
2026-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CARTIA XTPrescription
DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
CARTIA XTPrescription
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
CARTIA XTPrescription
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
CARTIA XTPrescription
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-01-24Labeling · Supplement 56 · standardAP
2026-01-24Labeling · Supplement 49 · standardAP
2026-01-24Labeling · Supplement 53 · standardAP
2011-10-28Labeling · Supplement 38AP
2007-05-11Labeling · Supplement 26AP
2006-12-04Labeling · Supplement 25AP
2003-11-18Supplement · Supplement 18 — Review ↗AP
2002-12-24Manufacturing (CMC) · Supplement 17 — Review ↗AP
2002-10-11Manufacturing (CMC) · Supplement 16 — Review ↗AP
2002-02-27Manufacturing (CMC) · Supplement 15 — Review ↗AP
2001-01-08Manufacturing (CMC) · Supplement 13 — Review ↗AP
2001-01-08Manufacturing (CMC) · Supplement 12 — Review ↗AP
2000-08-16Manufacturing (CMC) · Supplement 11 — Review ↗AP
2000-07-18Manufacturing (CMC) · Supplement 8 — Review ↗AP
2000-05-12Manufacturing (CMC) · Supplement 9 — Review ↗AP
1999-06-08Labeling · Supplement 7 — Review ↗AP
1999-06-08Manufacturing (CMC) · Supplement 3 — Review ↗AP
1999-06-08Manufacturing (CMC) · Supplement 1 — Review ↗AP
1999-06-08Labeling · Supplement 6 — Review ↗AP
1999-06-08Manufacturing (CMC) · Supplement 4 — Review ↗AP
1999-06-08Manufacturing (CMC) · Supplement 2 — Review ↗AP
1999-04-02Labeling · Supplement 5 — Review ↗AP
1998-07-09Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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