Treats hypertension. NDA 20062, held by Bausch. Diltiazem Hydrochloride.
As of Nov 13, 2026, NDA 20062 (Cardizem Cd), held by Bausch, was first approved by FDA on Dec 27, 1991, with 38 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 1992 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Aug 10, 1992 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Dec 27, 1991 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cardizem Cd120MG · capsule, extended release;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem Cd180MG · capsule, extended release;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem Cd240MG · capsule, extended release;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem Cd300MG · capsule, extended release;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem Cd360MG · capsule, extended release;oral | Diltiazem Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2025 | Supplement 48Labeling · Standard review | Approved | |
| Mar 26, 2020 | Supplement 46Labeling · Standard review | Approved | |
| Jan 23, 2017 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 18, 2016 | Supplement 43Labeling · Standard review | Approved | |
| Jun 29, 2016 | Supplement 42Labeling · Standard review | Approved | |
| Nov 22, 2010 | Supplement 40Labeling | Approved | |
| Mar 21, 2003 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 4, 2001 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 21, 2000 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1999 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1999 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1999 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1999 | Supplement 27Manufacturing · Standard review | Approved | |
| Apr 29, 1999 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1999 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1998 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1997 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1997 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1996 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 2, 1996 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 31, 1995 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1995 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 11, 1995 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 4, 1995 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1995 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1994 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1994 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1994 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1994 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 5, 1994 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1993 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1993 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 29, 1993 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1993 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 15, 1992 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Sep 18, 1992 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1992 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Aug 4, 1992 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1991 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
