NDA 19778, held by Merck. Hydrochlorothiazide; Lisinopril.
As of Nov 13, 2026, NDA 19778 (Prinzide), held by Merck, was first approved by FDA on Feb 16, 1989, with 45 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 1993 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 16, 1989 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prinzide12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrochlorothiazide; Lisinopril | DiscontinuedReference drug |
| Prinzide25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrochlorothiazide; Lisinopril | DiscontinuedReference drug |
| Prinzide12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Hydrochlorothiazide; Lisinopril | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2013 | Supplement 49Labeling · Standard review | Approved | |
| Jun 6, 2012 | Supplement 48Labeling · Standard review | Approved | |
| Nov 17, 2011 | Supplement 46Labeling · Standard review | Approved | |
| Aug 26, 2011 | Supplement 47Labeling · Standard review | Approved | |
| Jun 10, 2011 | Supplement 44Labeling · Standard review | Approved | |
| Jan 28, 2011 | Supplement 45Labeling · Standard review | Approved | |
| Oct 9, 2008 | Supplement 43Labeling · Standard review | Approved | |
| Oct 9, 2008 | Supplement 42Labeling · Standard review | Approved | |
| Feb 2, 2007 | Supplement 40Labeling · Standard review | Approved | |
| Oct 18, 2006 | Supplement 39Labeling · Standard review | Approved | |
| Jun 16, 2006 | Supplement 37Labeling · Standard review | Approved | |
| Oct 5, 2005 | Supplement 36Labeling · Standard review | Approved | |
| Mar 2, 2004 | Supplement 35Labeling · Standard review | Approved | |
| Nov 8, 2002 | Supplement 32Labeling · Standard review | Approved | |
| Jul 2, 2002 | Supplement 34Manufacturing · Standard review | Approved | |
| Aug 23, 2001 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 7, 2001 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jun 9, 2000 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1999 | Supplement 29Labeling · Standard review | Approved | |
| Oct 28, 1998 | Supplement 28Labeling · Standard review | Approved | |
| Sep 3, 1996 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 1, 1995 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1995 | Supplement 26Labeling · Standard review | Approved | None posted |
| Sep 28, 1995 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 8, 1995 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 30, 1995 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 21, 1995 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1995 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jul 24, 1994 | Supplement 19Labeling · Standard review | Approved | None posted |
| May 11, 1994 | Supplement 16Labeling · Standard review | Approved | None posted |
| Mar 10, 1994 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jan 14, 1994 | Supplement 15Labeling · Standard review | Approved | None posted |
| Nov 18, 1993 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 23, 1993 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 10, 1993 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 13, 1992 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 7, 1992 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 23, 1992 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1991 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 6, 1991 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 12, 1990 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 30, 1989 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1989 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 16, 1989 | 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
