Treats hypertension. NDA 20033, held by Validus Pharms. Benazepril Hydrochloride; Hydrochlorothiazide.
As of Nov 13, 2026, NDA 20033 (Lotensin Hct), held by Validus Pharms, was first approved by FDA on May 19, 1992, with 44 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 1992 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotensin Hct5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Benazepril Hydrochloride; Hydrochlorothiazide | DiscontinuedReference drug |
| Lotensin Hct10MG;12.5MG · tablet;oral | Benazepril Hydrochloride; Hydrochlorothiazide | RxReference drug |
| Lotensin Hct20MG;25MG · tablet;oral | Benazepril Hydrochloride; Hydrochlorothiazide | RxReference drug |
| Lotensin Hct20MG;12.5MG · tablet;oral | Benazepril Hydrochloride; Hydrochlorothiazide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2020 | Supplement 63Labeling · Standard review | Approved | |
| Aug 8, 2018 | Supplement 62Labeling · Standard review | Approved | |
| Aug 3, 2017 | Supplement 61Labeling · Standard review | Approved | |
| Jun 3, 2016 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| May 5, 2016 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2016 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Aug 25, 2015 | Supplement 52Labeling · Standard review | Approved | |
| Jul 7, 2015 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2014 | Supplement 50Labeling · Standard review | Approved | |
| Aug 14, 2014 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jul 22, 2014 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Sep 21, 2012 | Supplement 47Labeling | Approved | |
| Jul 27, 2012 | Supplement 46Labeling | Approved | |
| Feb 16, 2012 | Supplement 43Labeling | Approved | |
| Jan 19, 2012 | Supplement 45Labeling | Approved | |
| Jun 14, 2011 | Supplement 41Labeling | Approved | |
| Mar 17, 2011 | Supplement 40Labeling | Approved | |
| Nov 10, 2009 | Supplement 38Labeling | Approved | |
| Jan 22, 2009 | Supplement 37Labeling · Standard review | Approved | |
| May 29, 2008 | Supplement 36Labeling · Standard review | Approved | |
| Feb 2, 2007 | Supplement 33Labeling · Standard review | Approved | |
| Oct 29, 2003 | Supplement 25Labeling · Standard review | Approved | |
| Oct 25, 2002 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 20, 2002 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 29, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 14, 2001 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 30, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 16, 2001 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 13, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 10, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1999 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1998 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 9, 1997 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jan 13, 1997 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1996 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 2, 1995 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 5, 1995 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 20, 1993 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 21, 1993 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 30, 1993 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1993 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1992 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 23, 1992 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1992 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 19, 1992 | 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
