Treats hypertension. NDA 18998, held by Bausch. Enalapril Maleate.
As of Nov 13, 2026, NDA 18998 (Vasotec), held by Bausch, was first approved by FDA on Dec 24, 1985, with 65 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).
| Feb 13, 2001 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Nov 4, 1993 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Apr 8, 1992 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Jun 12, 1990 | Supplement 22Efficacy (new indication or use) | Approved | |
| Jun 24, 1988 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Dec 24, 1985 | Original applicationNew molecular entity · Priority review | Approved |
| Vasotec5MG · tablet;oral | Enalapril Maleate | RxReference drug |
| Vasotec10MG · tablet;oral | Enalapril Maleate | RxReference drug |
| Vasotec20MG · tablet;oral | Enalapril Maleate | RxReference drug |
| Vasotec2.5MG · tablet;oral | Enalapril Maleate | RxReference drug |
| Aug 1, 2018 | Supplement 83Labeling · Standard review | Approved | |
| Jul 21, 2017 | Supplement 82Labeling · Standard review | Approved | |
| Aug 25, 2015 | Supplement 80Labeling · Standard review | Approved | |
| Dec 24, 2014 | Supplement 79Labeling · Standard review | Approved | |
| Sep 13, 2012 | Supplement 77Labeling | Approved | |
| Feb 17, 2012 | Supplement 76Labeling | Approved | |
| Sep 25, 2008 | Supplement 71Labeling · Standard review | Approved | |
| Oct 31, 2007 | Supplement 70Labeling · Standard review | Approved | |
| Oct 10, 2002 | Supplement 64Manufacturing · Priority review | Approved | |
| Aug 30, 2002 | Supplement 63Manufacturing · Priority review | Approved | |
| Apr 3, 2002 | Supplement 62Manufacturing · Priority review | Approved | |
| Feb 4, 2002 | Supplement 61Manufacturing · Priority review | Approved | |
| Nov 27, 2001 | Supplement 58Labeling · Standard review | Approved | |
| Feb 13, 2001 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Feb 17, 1999 | Supplement 57Labeling · Standard review | Approved | |
| Dec 10, 1997 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jul 23, 1997 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Jul 21, 1997 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Jun 11, 1997 | Supplement 53Labeling · Standard review | Approved | |
| Feb 3, 1997 | Supplement 52Manufacturing · Priority review | Approved | |
| Jan 9, 1997 | Supplement 51Manufacturing · Priority review | Approved | |
| Jul 31, 1996 | Supplement 34Labeling · Standard review | Approved | |
| Mar 22, 1996 | Supplement 50Manufacturing · Priority review | Approved | |
| Sep 28, 1995 | Supplement 46Labeling · Standard review | Approved | |
| Sep 19, 1995 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Sep 19, 1995 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Sep 19, 1995 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1994 | Supplement 41Manufacturing · Priority review | Approved | |
| Jul 25, 1994 | Supplement 45Labeling · Standard review | Approved | |
| Jul 15, 1994 | Supplement 42Manufacturing · Priority review | Approved | |
| May 16, 1994 | Supplement 44Labeling · Standard review | Approved | |
| May 11, 1994 | Supplement 38Labeling · Standard review | Approved | |
| Feb 18, 1994 | Supplement 43Labeling · Standard review | Approved | |
| Jan 14, 1994 | Supplement 39Labeling · Standard review | Approved | |
| Nov 4, 1993 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Oct 21, 1993 | Supplement 40Labeling · Standard review | Approved | |
| Jul 26, 1993 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1993 | Supplement 37Labeling · Standard review | Approved | None posted |
| Feb 24, 1993 | Supplement 36Labeling · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Sep 30, 1992 | Supplement 33Labeling | Approved | None posted |
| May 13, 1992 | Supplement 30Labeling | Approved | None posted |
| May 7, 1992 | Supplement 31Labeling | Approved | None posted |
| Apr 8, 1992 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Aug 2, 1991 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Feb 20, 1991 | Supplement 17Manufacturing · Priority review | Approved | |
| Feb 6, 1991 | Supplement 25Labeling | Approved | |
| Nov 28, 1990 | Supplement 24Labeling | Approved | |
| Jul 19, 1990 | Supplement 23Manufacturing · Priority review | Approved | |
| Jun 12, 1990 | Supplement 22Efficacy (new indication or use) | Approved | |
| Mar 9, 1990 | Supplement 21Labeling | Approved | |
| Nov 30, 1989 | Supplement 20Labeling | Approved | |
| Apr 18, 1989 | Supplement 18Labeling | Approved | |
| Mar 29, 1989 | Supplement 15Labeling | Approved | |
| Jan 10, 1989 | Supplement 16Labeling | Approved | |
| Aug 3, 1988 | Supplement 13Manufacturing · Priority review | Approved | |
| Jul 26, 1988 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jun 24, 1988 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Apr 25, 1988 | Supplement 11Labeling | Approved | |
| Jul 10, 1987 | Supplement 9Manufacturing · Priority review | Approved | |
| May 14, 1987 | Supplement 5Labeling | Approved | |
| Jan 28, 1987 | Supplement 6Labeling | Approved | |
| Nov 7, 1986 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1986 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Oct 3, 1986 | Supplement 4Labeling | Approved | None posted |
| Dec 24, 1985 | Original applicationNew molecular entity · Priority review | Approved |
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
