Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020386
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COZAAR LOSARTAN POTASSIUM 25MG TABLET;ORAL Discontinued None Yes No
COZAAR LOSARTAN POTASSIUM 50MG TABLET;ORAL Discontinued None Yes No
COZAAR LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/14/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020386Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2018 SUPPL-62 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020386s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020386Orig1s062Ltr.pdf
09/29/2014 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s061ltr.pdf
01/17/2014 SUPPL-60 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020386s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020386Orig1s060ltr_replace.pdf
02/20/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/27/2013 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020386s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020386Orig1s058ltr.pdf
09/28/2012 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020386s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020386Orig1s057ltr.pdf
11/17/2011 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020386Orig1s056Lbl_REPLACEMENT.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf
12/11/2015 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020386s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020386Orig1s054ltr.pdf
06/10/2011 SUPPL-53 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
09/23/2010 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020386s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020386s052ltr.pdf
06/05/2009 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020386s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020386s049ltr.pdf
09/21/2006 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf
08/29/2006 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s045ltr.pdf
09/21/2006 SUPPL-43 Labeling Letter (PDF)
Patient Package Insert (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s043, s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020386s043PI.pdf
03/31/2006 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020386s042ltr.pdf
04/12/2005 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s040,020387s034ltr.pdf
04/12/2005 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020386s039,020387s035ltr.pdf
03/25/2003 SUPPL-32 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020386s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20386se1-032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-386s032_Cozaar.cfm
10/23/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/2004 SUPPL-29 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm
09/17/2002 SUPPL-28 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20386s28lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20386se1-028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-386s028_Cozaar.cfm
01/10/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/24/2001 SUPPL-26 Labeling

Label is not available on this site.

06/22/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/16/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-22 Labeling

Label is not available on this site.

02/23/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/2000 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf
03/11/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020386s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20386slr019,se5-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-386S019S029_Cozaar.cfm
01/28/2000 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf
06/09/1999 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20386S017_Cozaar.pdf
05/13/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1998 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386s015_Cozaar.pdf
08/31/1998 SUPPL-14 Labeling

Label is not available on this site.

08/31/1998 SUPPL-13 Labeling

Label is not available on this site.

04/03/1998 SUPPL-12 Labeling

Label is not available on this site.

08/31/1998 SUPPL-11 Labeling

Label is not available on this site.

03/27/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/13/1998 SUPPL-8 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20386-s008_cozaar.pdf
11/07/1997 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf
02/25/1998 SUPPL-6 Labeling

Label is not available on this site.

08/07/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1996 SUPPL-4 Labeling

Label is not available on this site.

12/01/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-2 Labeling

Label is not available on this site.

12/29/1995 SUPPL-1 Efficacy-Accelerated Approval Confirmatory Study

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

COZAAR

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COZAAR LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription Yes AB 020386 MERCK SHARP DOHME
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090428 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090083 AUROBINDO PHARMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 201170 CADISTA PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 203835 HETERO LABS LTD V
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 077459 HIKMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 200290 IPCA LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 078232 LUPIN LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 202230 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091541 MICRO LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091590 MYLAN
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091497 PRINSTON INC
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 077424 SANDOZ
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090382 STRIDES PHARMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090467 TORRENT PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 203030 UNICHEM LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090544 UPSHER SMITH LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091129 WATSON LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 078243 ZYDUS PHARMS USA INC

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