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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020386
Company: ORGANON
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
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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf
01/17/2014 SUPPL-60 Labeling-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
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