Treats hypertension. NDA 20386, held by Organon. Losartan Potassium.
As of Nov 13, 2026, NDA 20386 (Cozaar), held by Organon, was first approved by FDA on Apr 14, 1995, with 50 approved supplements and 0 published complete response letters.
COZAAR is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2004 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2003 | Supplement 32Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2002 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Dec 29, 1995 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 14, 1995 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cozaar25MG · tablet;oral | Losartan Potassium | RxReference drug |
| Cozaar50MG · tablet;oral | Losartan Potassium | RxReference drug |
| Cozaar100MG · tablet;oral | Losartan Potassium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2025 | Supplement 69Labeling · Standard review | Approved | |
| Oct 15, 2021 | Supplement 64Labeling · Standard review | Approved | |
| Oct 12, 2018 | Supplement 62Labeling · Standard review | Approved | |
| Dec 11, 2015 | Supplement 54Labeling · Standard review | Approved | |
| Sep 29, 2014 | Supplement 61Labeling · Standard review | Approved | |
| Feb 20, 2014 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jan 17, 2014 | Supplement 60Labeling · Standard review | Approved | |
| Mar 27, 2013 | Supplement 58Labeling · Standard review | Approved | |
| Sep 28, 2012 | Supplement 57Labeling | Approved | |
| Nov 17, 2011 | Supplement 56Labeling | Approved | |
| Jun 10, 2011 | Supplement 53Labeling | Approved | |
| Sep 23, 2010 | Supplement 52Labeling | Approved | |
| Jun 5, 2009 | Supplement 49Labeling · Standard review | Approved | |
| Sep 21, 2006 | Supplement 46Labeling · Standard review | Approved | |
| Sep 21, 2006 | Supplement 43Labeling · Standard review | Approved | |
| Aug 29, 2006 | Supplement 45Labeling · Standard review | Approved | |
| Mar 31, 2006 | Supplement 42Labeling · Standard review | Approved | |
| Apr 12, 2005 | Supplement 40Labeling · Standard review | Approved | |
| Apr 12, 2005 | Supplement 39Labeling · Standard review | Approved | |
| Mar 11, 2004 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 2004 | Supplement 19Labeling · Standard review | Approved | |
| Mar 25, 2003 | Supplement 32Efficacy (new indication or use) · Priority review | Approved | |
| Oct 23, 2002 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Sep 17, 2002 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Jan 10, 2002 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Oct 3, 2001 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 24, 2001 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jul 3, 2001 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 22, 2001 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 16, 2001 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 23, 2000 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 28, 2000 | Supplement 18Labeling · Standard review | Approved | |
| Jan 19, 2000 | Supplement 20Labeling · Standard review | Approved | |
| Jun 9, 1999 | Supplement 17Labeling · Standard review | Approved | |
| May 13, 1999 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1998 | Supplement 15Labeling · Standard review | Approved | |
| Oct 13, 1998 | Supplement 8Manufacturing · Standard review | Approved | |
| Aug 31, 1998 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 31, 1998 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 31, 1998 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 27, 1998 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1998 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1998 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 7, 1997 | Supplement 7Labeling · Standard review | Approved | |
| Aug 7, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1996 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 29, 1995 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 1, 1995 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1995 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 14, 1995 | Original applicationNew molecular entity · Standard 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
