FDA NDA · NDA020386

COZAAR

losartan potassium

Sponsor: ORGANON

APPLICATION

NDA020386

TYPE

NDA

ORIGINAL APPROVAL

1995-04-14

LATEST ACTION

2025-06-20

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

COZAAR · ReferencePrescription

LOSARTAN POTASSIUM 50MG · TABLET · ORAL

COZAAR · ReferencePrescription

LOSARTAN POTASSIUM 100MG · TABLET · ORAL

COZAAR · ReferencePrescription

LOSARTAN POTASSIUM 25MG · TABLET · ORAL

Approval history

2025-06-20Labeling · Supplement 69 · standard — Letter ↗AP

2021-10-15Labeling · Supplement 64 · standard — Letter ↗AP

2018-10-12Labeling · Supplement 62 · standard — Label ↗AP

2015-12-11Labeling · Supplement 54 · standard — Label ↗AP

2014-09-29Labeling · Supplement 61 · standard — Label ↗AP

2014-02-20Manufacturing (CMC) · Supplement 59 · standardAP

2014-01-17Labeling · Supplement 60 · standard — Label ↗AP

2013-03-27Labeling · Supplement 58 · standard — Label ↗AP

2012-09-28Labeling · Supplement 57 · unknown — Letter ↗AP

2011-11-17Labeling · Supplement 56 · unknown — Label ↗AP

2011-06-10Labeling · Supplement 53 · unknown — Letter ↗AP

2010-09-23Labeling · Supplement 52 · unknown — Letter ↗AP

2009-06-05Labeling · Supplement 49 · standard — Letter ↗AP

2006-09-21Labeling · Supplement 46 · standard — Patient Information Sheet ↗AP

2006-09-21Labeling · Supplement 43 · standard — Patient Package Insert ↗AP

2006-08-29Labeling · Supplement 45 · standard — Label ↗AP

2006-03-31Labeling · Supplement 42 · standard — Letter ↗AP

2005-04-12Labeling · Supplement 40 · standard — Label ↗AP

2005-04-12Labeling · Supplement 39 · standard — Label ↗AP

2004-03-11Efficacy · Supplement 29 · standard — Review ↗AP

2004-03-11Labeling · Supplement 19 · standard — Review ↗AP

2003-03-25Efficacy · Supplement 32 · priority — Review ↗AP

2002-10-23Manufacturing (CMC) · Supplement 31 · standardAP

2002-09-17Efficacy · Supplement 28 · priority — Review ↗AP

2002-01-10Manufacturing (CMC) · Supplement 27 · standardAP

2001-10-03Labeling · Supplement 22 · standardAP

2001-08-24Labeling · Supplement 26 · standardAP

2001-07-03Manufacturing (CMC) · Supplement 23 · standardAP

2001-06-22Manufacturing (CMC) · Supplement 25 · standardAP

2001-05-16Manufacturing (CMC) · Supplement 24 · standardAP

2000-02-23Manufacturing (CMC) · Supplement 21 · standardAP

2000-01-28Labeling · Supplement 18 · standard — Review ↗AP

2000-01-19Labeling · Supplement 20 · standard — Review ↗AP

1999-06-09Labeling · Supplement 17 · standard — Review ↗AP

1999-05-13Manufacturing (CMC) · Supplement 16 · standardAP

1998-11-24Labeling · Supplement 15 · standard — Review ↗AP

1998-10-13Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP

1998-08-31Labeling · Supplement 11 · standardAP

1998-08-31Labeling · Supplement 14 · standardAP

1998-08-31Labeling · Supplement 13 · standardAP

VIEW ON DRUGS@FDA ↗

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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COZAAR

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Approval history

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