Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020387
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|
| 06/20/2025 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020387s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020387Orig1s076ltr.pdf | |
| 03/17/2023 | SUPPL-71 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020387s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020387Orig1s071ltr.pdf | |
| 08/20/2020 | SUPPL-67 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020387s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020387Orig1s067ltr.pdf | |
| 08/20/2020 | SUPPL-66 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022387s066lbl.pdf | ||
| 11/07/2019 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020387s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020387Orig1s064ltr.pdf | |
| 10/12/2018 | SUPPL-63 | Labeling-Package Insert, Labeling-Patient 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-Package Insert, Labeling-Patient 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-Package Insert, Labeling-Patient 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.html | |
| 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.html | |
| 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.html | |
| 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 |
|---|---|---|---|---|---|
| 06/20/2025 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020387s076lbl.pdf | |
| 03/17/2023 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020387s071lbl.pdf | |
| 03/17/2023 | SUPPL-71 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020387s071lbl.pdf | |
| 08/20/2020 | SUPPL-67 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020387s067lbl.pdf | |
| 08/20/2020 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020387s067lbl.pdf | |
| 08/20/2020 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022387s066lbl.pdf | |
| 11/07/2019 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020387s064lbl.pdf | |
| 10/12/2018 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020387s063lbl.pdf | |
| 10/12/2018 | SUPPL-63 | Labeling-Patient 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020387s059lbledt.pdf | |
| 01/17/2014 | SUPPL-59 | Labeling-Patient 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020387s056lbl.pdf | |
| 09/28/2012 | SUPPL-56 | Labeling-Patient 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;50MG
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;50MG | TABLET;ORAL | Prescription | Yes | AB | 020387 | ORGANON |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 091617 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 091629 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 077948 | CHARTWELL RX |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 078245 | LUPIN LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 202289 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 204901 | PRINSTON INC |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 077157 | TEVA PHARMS |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 204832 | UNICHEM |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 078385 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 25MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 020387 | ORGANON |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 091617 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 091629 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077948 | CHARTWELL RX |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078245 | LUPIN LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 202289 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 204901 | PRINSTON INC |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077157 | TEVA PHARMS |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 204832 | UNICHEM |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078385 | ZYDUS PHARMS USA INC |
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 | ORGANON |
| 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 | 077948 | CHARTWELL RX |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| 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 | 204901 | PRINSTON INC |
| 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 | 204832 | UNICHEM |