药品注册申请号：091316
申请类型：ANDA (仿制药申请)
申请人：DR REDDYS LABS LTD
申请人全名：DR REDDYS LABORATORIES LTD
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 FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML No No AP 2011/07/11 2011/07/11 Prescription
002 FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML No No AP 2011/07/11 Prescription
003 FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML No No AP 2011/07/11 Prescription
004 FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML No No AP 2011/07/11 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
2016/02/18 SUPPL-3（补充） Approval Labeling STANDARD
2014/03/19 SUPPL-2（补充） Approval Labeling STANDARD
2011/07/11 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:FONDAPARINUX SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:2.5MG/0.5ML 治疗等效代码:AP
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
021345 001 NDA ARIXTRA FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription Yes Yes AP 2001/12/07 MYLAN IRELAND LTD
091316 001 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription No No AP 2011/07/11 DR REDDYS LABS LTD
206918 001 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription No No AP 2017/12/26 EUGIA PHARMA
206812 001 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription No No AP 2018/05/15 HENGRUI PHARMA
208615 001 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription No No AP 2018/11/14 SCINOPHARM TAIWAN
216493 001 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 2.5MG/0.5ML Prescription No No AP 2024/08/19 HANGZHOU ZHONGMEI
活性成分:FONDAPARINUX SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:5MG/0.4ML 治疗等效代码:AP
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
021345 002 NDA ARIXTRA FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription Yes Yes AP 2004/05/28 MYLAN IRELAND LTD
091316 002 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription No No AP 2011/07/11 DR REDDYS LABS LTD
206918 002 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription No No AP 2017/12/26 EUGIA PHARMA
206812 002 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription No No AP 2018/05/15 HENGRUI PHARMA
208615 002 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription No No AP 2018/11/14 SCINOPHARM TAIWAN
216493 002 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 5MG/0.4ML Prescription No No AP 2024/08/19 HANGZHOU ZHONGMEI
活性成分:FONDAPARINUX SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:7.5MG/0.6ML 治疗等效代码:AP
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
021345 003 NDA ARIXTRA FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription Yes Yes AP 2004/05/28 MYLAN IRELAND LTD
091316 003 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription No No AP 2011/07/11 DR REDDYS LABS LTD
206918 003 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription No No AP 2017/12/26 EUGIA PHARMA
206812 003 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription No No AP 2018/05/15 HENGRUI PHARMA
208615 003 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription No No AP 2018/11/14 SCINOPHARM TAIWAN
216493 003 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 7.5MG/0.6ML Prescription No No AP 2024/08/19 HANGZHOU ZHONGMEI
活性成分:FONDAPARINUX SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:10MG/0.8ML 治疗等效代码:AP
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
021345 004 NDA ARIXTRA FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription Yes Yes AP 2004/05/28 MYLAN IRELAND LTD
091316 004 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription No No AP 2011/07/11 DR REDDYS LABS LTD
206918 004 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription No No AP 2017/12/26 EUGIA PHARMA
206812 004 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription No No AP 2018/05/15 HENGRUI PHARMA
208615 004 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription No No AP 2018/11/14 SCINOPHARM TAIWAN
216493 004 ANDA FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTABLE;SUBCUTANEOUS 10MG/0.8ML Prescription No No AP 2024/08/19 HANGZHOU ZHONGMEI
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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