药品注册申请号：020387
申请类型：NDA (新药申请)
申请人：ORGANON
申请人全名：ORGANON LLC A SUB OF ORGANON AND CO
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Yes No AB 1995/04/28 1995/04/28 Prescription
002 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Yes No AB 1998/11/10 Prescription
003 HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Yes No AB 2005/10/20 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1995/04/28 ORIG-1（原始申请） Approval Type 4 - New Combination STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/06/20 SUPPL-76（补充） Approval Labeling-Package Insert STANDARD
2023/03/17 SUPPL-71（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2020/08/20 SUPPL-67（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2020/08/20 SUPPL-66（补充） Approval STANDARD
2019/11/07 SUPPL-64（补充） Approval Labeling-Package Insert STANDARD
2018/10/12 SUPPL-63（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2015/12/11 SUPPL-47（补充） Approval Labeling-Package Insert STANDARD
2014/09/30 SUPPL-60（补充） Approval Labeling-Package Insert STANDARD
2014/01/17 SUPPL-59（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2013/03/27 SUPPL-57（补充） Approval Labeling-Package Insert STANDARD
2012/09/28 SUPPL-56（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert UNKNOWN
2011/11/17 SUPPL-54（补充） Approval Labeling-Package Insert UNKNOWN
2011/08/26 SUPPL-55（补充） Approval Labeling-Package Insert UNKNOWN
2011/08/17 SUPPL-52（补充） Approval Labeling-Package Insert UNKNOWN
2011/06/10 SUPPL-50（补充） Approval Labeling-Container/Carton Labels UNKNOWN
2010/09/21 SUPPL-48（补充） Approval Labeling-Package Insert UNKNOWN
2009/06/12 SUPPL-45（补充） Approval Labeling STANDARD
2006/12/21 SUPPL-40（补充） Approval Labeling STANDARD
2006/08/29 SUPPL-41（补充） Approval Labeling STANDARD
2006/04/20 SUPPL-38（补充） Approval Labeling STANDARD
2005/10/20 SUPPL-37（补充） Approval Efficacy-New Dosing Regimen STANDARD
2005/04/12 SUPPL-35（补充） Approval Labeling STANDARD
2005/04/12 SUPPL-34（补充） Approval Labeling STANDARD
2005/04/05 SUPPL-33（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2003/09/30 SUPPL-27（补充） Approval Efficacy-New Indication STANDARD
2003/09/30 SUPPL-15（补充） Approval Labeling STANDARD
2003/09/30 SUPPL-13（补充） Approval Labeling STANDARD
2003/01/08 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2002/11/07 SUPPL-24（补充） Approval Labeling STANDARD
2002/10/23 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/01/10 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2001/10/03 SUPPL-18（补充） Approval Labeling STANDARD
2001/08/24 SUPPL-22（补充） Approval Labeling STANDARD
2001/07/03 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/06/22 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2001/05/16 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/02/23 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/01/28 SUPPL-14（补充） Approval Labeling STANDARD
2000/01/19 SUPPL-17（补充） Approval Labeling STANDARD
1999/06/09 SUPPL-12（补充） Approval Labeling STANDARD
1998/11/24 SUPPL-11（补充） Approval Labeling STANDARD
1998/11/10 SUPPL-8（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1998/08/25 SUPPL-10（补充） Approval Labeling STANDARD
1998/08/24 SUPPL-6（补充） Approval Labeling STANDARD
1998/04/03 SUPPL-9（补充） Approval Labeling STANDARD
1998/03/27 SUPPL-7（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/11/07 SUPPL-5（补充） Approval Labeling STANDARD
1996/07/18 SUPPL-4（补充） Approval Labeling STANDARD
1995/12/01 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1995/11/22 SUPPL-2（补充） Approval Labeling STANDARD
1995/11/06 SUPPL-1（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 5138069 2009/08/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5138069*PED 2010/02/11 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197 2009/10/06 Y U-538 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197*PED 2010/04/06 U-538 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5608075 2014/03/04 PDF格式**本条是由Drugfuture回溯的历史信息**
5608075*PED 2014/09/04 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5138069 2009/08/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5138069*PED 2010/02/11 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197 2009/10/06 Y U-538 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197*PED 2010/04/06 U-538 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5608075 2014/03/04 PDF格式**本条是由Drugfuture回溯的历史信息**
5608075*PED 2014/09/04 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5138069 2009/08/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5138069*PED 2010/02/11 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197 2009/10/08 Y U-3 U-538 PDF格式**本条是由Drugfuture回溯的历史信息**
5153197*PED 2010/04/06 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-415 2006/09/30**本条是由Drugfuture回溯的历史信息**
002 I-415 2006/09/30**本条是由Drugfuture回溯的历史信息**
003 I-415 2006/09/30**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;50MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020387 001 NDA HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription Yes No AB 1995/04/28 ORGANON
077157 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/04/06 TEVA PHARMS
077948 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 CHARTWELL RX
078245 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 LUPIN LTD
078385 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
091629 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
091617 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/02/17 ALEMBIC PHARMS LTD
202289 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/08/09 MACLEODS PHARMS LTD
201845 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
201682 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Discontinued No No AB 2013/03/01 IPCA LABS LTD
204832 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2017/07/21 UNICHEM
204901 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Prescription No No AB 2017/11/06 PRINSTON INC
218015 001 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG Discontinued No No AB 2023/09/29 GRANULES
>>>活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:25MG;100MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020387 002 NDA HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription Yes No AB 1998/11/10 ORGANON
091629 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No Yes AB 2010/01/06 AUROBINDO PHARMA
077157 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/04/06 TEVA PHARMS
077948 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 CHARTWELL RX
078245 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 LUPIN LTD
078385 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
091617 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/02/17 ALEMBIC PHARMS LTD
202289 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/08/09 MACLEODS PHARMS LTD
201845 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
201682 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Discontinued No No AB 2013/03/01 IPCA LABS LTD
204832 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2017/07/21 UNICHEM
204901 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Prescription No No AB 2017/11/06 PRINSTON INC
218015 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG Discontinued No No AB 2023/09/29 GRANULES
>>>活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;100MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020387 003 NDA HYZAAR HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription Yes No AB 2005/10/20 ORGANON
077157 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2010/04/06 TEVA PHARMS
078245 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2010/05/21 LUPIN LTD
077948 003 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2010/08/19 CHARTWELL RX
091629 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
091617 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2012/02/17 ALEMBIC PHARMS LTD
202289 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2012/08/09 MACLEODS PHARMS LTD
201845 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
201682 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Discontinued No No AB 2013/03/01 IPCA LABS LTD
204832 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2017/07/21 UNICHEM
204901 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Prescription No No AB 2017/11/06 PRINSTON INC
218015 002 ANDA LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG Discontinued No No AB 2023/09/29 GRANULES
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