Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020387
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;50MG TABLET;ORAL Discontinued None Yes No
HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25MG;100MG TABLET;ORAL Discontinued None Yes No
HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/28/1995 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2018 SUPPL-63 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020387s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20387Orig1s063ltr.pdf
09/30/2014 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s060ltr.pdf
01/17/2014 SUPPL-59 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020387Orig1s059_replace_ltr.pdf
03/27/2013 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020387Orig1s057ltr.pdf
09/28/2012 SUPPL-56 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020387Orig1s056ltr.pdf
08/26/2011 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s055ltr.pdf
11/17/2011 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387Orig1s054Lbl_REPLACEMENT.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf
08/17/2011 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s052ltr.pdf
06/10/2011 SUPPL-50 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf
09/21/2010 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020387s048ltr.pdf
12/11/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020387s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020387Orig1s047ltr.pdf
06/12/2009 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020387s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020387s045ltr.pdf
08/29/2006 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s041ltr.pdf
12/21/2006 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s040ltr.pdf
04/20/2006 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s038LTR.pdf
10/20/2005 SUPPL-37 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020387_s037_hyzaar.pdf
04/12/2005 SUPPL-35 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
04/12/2005 SUPPL-34 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
04/05/2005 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020387s033ltr.pdf
09/30/2003 SUPPL-27 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm
01/08/2003 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/23/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20387slr024ltr.pdf
01/10/2002 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/24/2001 SUPPL-22 Labeling

Label is not available on this site.

06/22/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/16/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-18 Labeling

Label is not available on this site.

01/19/2000 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s020_cozaar.pdf
02/23/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm
01/28/2000 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20386-s018_cozaar.pdf
09/30/2003 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20387se1-027,slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-387S013S015S027Hyzaar.cfm
06/09/1999 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20387S012_Hyzaar.pdf
11/24/1998 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20387s011_Hyzaar.pdf
08/25/1998 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S010_Hyzaar.pdf
04/03/1998 SUPPL-9 Labeling

Label is not available on this site.

11/10/1998 SUPPL-8 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S008_Hyzaar.pdf
03/27/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1998 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-387S006_Hyzaar.pdf
11/07/1997 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020386ap.pdf
07/18/1996 SUPPL-4 Labeling

Label is not available on this site.

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

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-387S003_Hyzaar.pdf
11/22/1995 SUPPL-2 Labeling

Label is not available on this site.

11/06/1995 SUPPL-1 Manufacturing (CMC)-Expiration Date

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-63 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020387s063lbl.pdf
10/12/2018 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020387s063lbl.pdf
12/11/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020387s047lbl.pdf
09/30/2014 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s060lbl.pdf
01/17/2014 SUPPL-59 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf
01/17/2014 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf
03/27/2013 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020387s057lbl.pdf
09/28/2012 SUPPL-56 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf
09/28/2012 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf
11/17/2011 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387Orig1s054Lbl_REPLACEMENT.pdf
08/26/2011 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s055lbl.pdf
08/17/2011 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020387s052lbl.pdf
09/21/2010 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020387s048lbl.pdf
06/12/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020387s045lbl.pdf
08/29/2006 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s041lbl.pdf
04/20/2006 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020387s038lbl.pdf
10/20/2005 SUPPL-37 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s037lbl.pdf
04/12/2005 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s039,020387s035lbl.pdf
04/12/2005 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020386s040,020387s034lbl.pdf
04/05/2005 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020387s033lbl.pdf
09/30/2003 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf
09/30/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf
09/30/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20387se1-027,slr015_hyzaar_lbl.pdf

HYZAAR

TABLET;ORAL; 12.5MG;100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription Yes AB 020387 MERCK SHARP DOHME
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 091617 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 091629 AUROBINDO PHARMA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 201845 CADISTA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 201682 IPCA LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 078245 LUPIN LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 202289 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 091652 MYLAN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 204901 PRINSTON INC
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 077948 SANDOZ
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 077157 TEVA PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 090528 TORRENT PHARMS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 204832 UNICHEM LABS LTD
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5MG;100MG TABLET;ORAL Prescription No AB 077732 WEST-WARD PHARMS INT

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