NDA 18709, held by Apothecon. Captopril; Hydrochlorothiazide.
As of Nov 13, 2026, NDA 18709 (Capozide 25/15, Capozide 25/25, Capozide 50/25), held by Apothecon, was first approved by FDA on Oct 12, 1984, with 32 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 1991 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 12, 1984 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Capozide 25/1525MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril; Hydrochlorothiazide | DiscontinuedReference drug |
| Capozide 25/2525MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril; Hydrochlorothiazide | DiscontinuedReference drug |
| Capozide 50/2550MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril; Hydrochlorothiazide | DiscontinuedReference drug |
| Capozide 50/1550MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril; Hydrochlorothiazide | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2009 | Supplement 35Labeling · Standard review | Approved | |
| May 16, 2006 | Supplement 33Labeling · Standard review | Approved | |
| Jun 3, 1998 | Supplement 30Labeling · Standard review | Approved | None posted |
| May 20, 1997 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1996 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jul 31, 1996 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jun 26, 1996 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1995 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1994 | Supplement 21Labeling · Standard review | Approved | None posted |
| May 12, 1993 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1992 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jun 25, 1992 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 5, 1992 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1991 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1991 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 21, 1991 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 27, 1990 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 5, 1990 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1989 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 3, 1989 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jun 22, 1988 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 6, 1987 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 6, 1987 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1986 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1986 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 2, 1985 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 1, 1985 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1985 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1985 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1985 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1984 | Original applicationNew combination · 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
