An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020386
Company: ORGANON

Patient Information Sheet

Other Important Information from FDA

Products on NDA 20386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COZAAR	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Prescription	AB	Yes	No
COZAAR	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Prescription	AB	Yes	No
COZAAR	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020386

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2021	SUPPL-64	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020386s064lbl.pdf
10/12/2018	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf
10/12/2018	SUPPL-62	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf
12/11/2015	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf
09/29/2014	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf
01/17/2014	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf
01/17/2014	SUPPL-60	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf
03/27/2013	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf
09/28/2012	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf
11/17/2011	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf
09/23/2010	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf
06/05/2009	SUPPL-49	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf
08/29/2006	SUPPL-45	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf
04/12/2005	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf
04/12/2005	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf
03/11/2004	SUPPL-29	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf
03/11/2004	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf
03/25/2003	SUPPL-32	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf
09/17/2002	SUPPL-28	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf

Top