Manages chronic stable angina and angina due to coronary artery spasm. NDA 18602, held by Bausch. Diltiazem Hydrochloride.
As of Nov 13, 2026, NDA 18602 (Cardizem), held by Bausch, was first approved by FDA on Nov 5, 1982, with 54 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 1993 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Dec 8, 1986 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1986 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Nov 5, 1982 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cardizem30MG · tablet;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem60MG · tablet;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem90MG · tablet;oral | Diltiazem Hydrochloride | RxReference drug |
| Cardizem120MG · tablet;oral | Diltiazem Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2025 | Supplement 72Labeling · Standard review | Approved | |
| Jun 29, 2020 | Supplement 69Manufacturing | Approved | |
| Nov 18, 2016 | Supplement 67Labeling · Standard review | Approved | |
| Nov 21, 2014 | Supplement 65Labeling · Standard review | Approved | |
| Jun 24, 2014 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Nov 23, 2010 | Supplement 63Labeling | Approved | |
| Mar 21, 2003 | Supplement 56Labeling · Standard review | Approved | None posted |
| Jun 4, 2001 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1999 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1998 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1997 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1997 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1996 | Supplement 50Labeling · Standard review | Approved | None posted |
| Apr 2, 1996 | Supplement 51Labeling · Standard review | Approved | None posted |
| Aug 29, 1995 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| May 4, 1995 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1994 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1994 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1994 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1994 | Supplement 40Labeling | Approved | None posted |
| Sep 21, 1994 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1993 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1993 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Apr 13, 1993 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1993 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| May 27, 1992 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1991 | Supplement 38Labeling | Approved | None posted |
| Mar 14, 1991 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Apr 12, 1990 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1989 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1989 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1988 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1988 | Supplement 32Labeling | Approved | None posted |
| Aug 12, 1988 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1988 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1988 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1987 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1987 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1987 | Supplement 25Labeling | Approved | None posted |
| Dec 8, 1986 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1986 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1986 | Supplement 22Labeling | Approved | None posted |
| Jun 20, 1985 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1985 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1984 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1983 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1983 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1983 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 27, 1983 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 27, 1983 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1983 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1983 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1982 | Original applicationNew molecular entity · 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
