药品注册申请号：040901
申请类型：ANDA (仿制药申请)
申请人：HETERO LABS LTD III
申请人全名：HETERO LABS LTD UNIT III
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 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG No No AA 2008/09/12 2008/09/12 Prescription
002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No AA 2008/09/12 Prescription
003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No AA 2008/09/12 Prescription
004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG No No AA 2008/09/12 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
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
2016/01/05 SUPPL-8（补充） Approval Labeling STANDARD
2008/09/12 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:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AA
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
087836 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 1982/10/05 STRIDES PHARMA
089097 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No Yes AA 1985/12/18 PLIVA
040901 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2008/09/12 HETERO LABS LTD III
090255 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AA 2008/12/15 INVAGEN PHARMS
090527 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2009/05/29 GLENMARK PHARMS LTD
086242 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2010/02/04 HERITAGE
040858 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2010/02/26 HERITAGE PHARMS INC
200737 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2012/12/07 ALKEM LABS LTD
205236 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2017/05/26 SCIEGEN PHARMS INC
211010 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AA 2024/08/21 MACLEODS PHARMS LTD
活性成分:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AA
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
086242 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA Approved Prior to Jan 1, 1982 HERITAGE
086961 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA Approved Prior to Jan 1, 1982 STRIDES PHARMA
088467 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes Yes AA 1984/05/01 PLIVA
040901 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2008/09/12 HETERO LABS LTD III
090255 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AA 2008/12/15 INVAGEN PHARMS
090527 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2009/05/29 GLENMARK PHARMS LTD
040858 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2010/02/26 HERITAGE PHARMS INC
200737 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2012/12/07 ALKEM LABS LTD
200770 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2013/05/03 STRIDES PHARMA
203845 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2014/09/18 CADILA PHARMS LTD
205236 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2017/05/26 SCIEGEN PHARMS INC
211010 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2024/08/21 MACLEODS PHARMS LTD
活性成分:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AA
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
086242 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA Approved Prior to Jan 1, 1982 HERITAGE
086962 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA Approved Prior to Jan 1, 1982 STRIDES PHARMA
088468 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes Yes AA 1984/05/01 PLIVA
040901 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2008/09/12 HETERO LABS LTD III
090255 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AA 2008/12/15 INVAGEN PHARMS
090527 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2009/05/29 GLENMARK PHARMS LTD
040858 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2010/02/26 HERITAGE PHARMS INC
200737 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2012/12/07 ALKEM LABS LTD
200770 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2013/05/03 STRIDES PHARMA
203845 002 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2014/09/18 CADILA PHARMS LTD
205236 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2017/05/26 SCIEGEN PHARMS INC
211010 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2024/08/21 MACLEODS PHARMS LTD
活性成分:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 治疗等效代码:AA
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
088391 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 1983/09/27 STRIDES PHARMA
089098 001 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No Yes AA 1985/12/18 PLIVA
040901 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2008/09/12 HETERO LABS LTD III
090255 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Discontinued No No AA 2008/12/15 INVAGEN PHARMS
090527 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2009/05/29 GLENMARK PHARMS LTD
086242 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2010/02/04 HERITAGE
040858 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2010/02/26 HERITAGE PHARMS INC
200737 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2012/12/07 ALKEM LABS LTD
200770 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2013/05/03 STRIDES PHARMA
203845 003 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2014/09/18 CADILA PHARMS LTD
205236 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2017/05/26 SCIEGEN PHARMS INC
211010 004 ANDA HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AA 2024/08/21 MACLEODS PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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