药品注册申请号：077459
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA INC
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 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG No No AB 2010/10/06 2010/10/06 Discontinued
002 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG No No AB 2010/10/06 Discontinued
003 LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG No No AB 2010/10/06 Discontinued
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
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/09/16 SUPPL-14（补充） Approval Labeling STANDARD
2020/09/30 SUPPL-12（补充） Approval Labeling STANDARD
2016/06/10 SUPPL-10（补充） Approval Labeling STANDARD
2015/06/13 SUPPL-9（补充） Approval Labeling STANDARD
2014/09/26 SUPPL-8（补充） Approval Labeling STANDARD
2013/03/19 SUPPL-7（补充） Approval Labeling STANDARD
2012/12/19 SUPPL-6（补充） Approval Labeling STANDARD
2011/02/15 SUPPL-2（补充） Approval Manufacturing (CMC)
2010/11/16 SUPPL-1（补充） Approval Labeling
2010/10/06 ORIG-1（原始申请） Approval
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
无
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
无
与本品治疗等效的药品
活性成分:LOSARTAN POTASSIUM 剂型/给药途径:TABLET;ORAL 规格:25MG 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
020386 001 NDA COZAAR LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription Yes No AB 1995/04/14 ORGANON
077424 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 CHARTWELL RX
077459 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Discontinued No No AB 2010/10/06 HIKMA
078232 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 LUPIN LTD
078243 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
090083 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
090382 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 STRIDES PHARMA
090428 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 ALEMBIC PHARMS LTD
091129 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2010/10/06 WATSON LABS
091497 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2011/06/06 PRINSTON INC
202230 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2012/05/30 MACLEODS PHARMS LTD
201170 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
091541 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2012/09/24 MICRO LABS
200290 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2013/08/30 IPCA LABS LTD
203835 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2015/08/12 HETERO LABS LTD V
203030 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2015/10/14 UNICHEM
215959 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2023/02/23 GRANULES
217396 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2023/08/14 MSN
218551 001 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 25MG Prescription No No AB 2024/06/04 APOTEX
活性成分:LOSARTAN POTASSIUM 剂型/给药途径:TABLET;ORAL 规格: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
020386 002 NDA COZAAR LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription Yes No AB 1995/04/14 ORGANON
077424 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 CHARTWELL RX
077459 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Discontinued No No AB 2010/10/06 HIKMA
078232 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 LUPIN LTD
078243 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
090083 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
090382 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 STRIDES PHARMA
090428 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 ALEMBIC PHARMS LTD
091129 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2010/10/06 WATSON LABS
091497 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2011/06/06 PRINSTON INC
202230 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2012/05/30 MACLEODS PHARMS LTD
201170 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
091541 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2012/09/24 MICRO LABS
200290 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2013/08/30 IPCA LABS LTD
203835 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2015/08/12 HETERO LABS LTD V
203030 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2015/10/14 UNICHEM
215959 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2023/02/23 GRANULES
217396 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2023/08/14 MSN
218551 002 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 50MG Prescription No No AB 2024/06/04 APOTEX
活性成分:LOSARTAN POTASSIUM 剂型/给药途径:TABLET;ORAL 规格: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
020386 003 NDA COZAAR LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription Yes Yes AB 1998/10/13 ORGANON
077424 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 CHARTWELL RX
077459 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Discontinued No No AB 2010/10/06 HIKMA
078232 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 LUPIN LTD
078243 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 ZYDUS PHARMS USA INC
090083 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 AUROBINDO PHARMA
090382 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 STRIDES PHARMA
090428 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 ALEMBIC PHARMS LTD
091129 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2010/10/06 WATSON LABS
091497 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2011/06/06 PRINSTON INC
202230 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2012/05/30 MACLEODS PHARMS LTD
201170 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2012/09/18 JUBILANT CADISTA
091541 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2012/09/24 MICRO LABS
200290 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2013/08/30 IPCA LABS LTD
203835 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2015/08/12 HETERO LABS LTD V
203030 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2015/10/14 UNICHEM
215959 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2023/02/23 GRANULES
217396 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2023/08/14 MSN
218551 003 ANDA LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET;ORAL 100MG Prescription No No AB 2024/06/04 APOTEX
更多信息
药品NDC数据与药品包装、标签说明书
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