药品注册申请号：205323
申请类型：ANDA (仿制药申请)
申请人：GLAND
申请人全名：GLAND PHARMA 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 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No AP 2017/02/06 2017/02/06 Prescription
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No AP 2019/11/18 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
2019/11/20 SUPPL-1（补充） Approval Labeling STANDARD
2017/02/06 ORIG-1（原始申请） Approval 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
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:HEPARIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:5,000 UNITS/ML 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
017037 002 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
017651 006 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017029 014 NDA HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription Yes Yes AP 1985/12/05 FRESENIUS KABI USA
090571 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2009/08/31 HOSPIRA INC
090808 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
091682 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2011/06/08 SANDOZ
202733 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
202957 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
206552 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2016/06/10 FRESENIUS KABI USA
205323 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2017/02/06 GLAND
203851 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2017/11/30 MYLAN LABS LTD
211007 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2019/05/28 NANJING KING-FRIEND
212061 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML Prescription No No AP 2020/07/15 NANJING KING-FRIEND
活性成分:HEPARIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:1,000 UNITS/ML 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
017037 001 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
017029 001 NDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
017029 013 NDA HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP 1985/12/05 FRESENIUS KABI USA
017029 010 NDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription Yes Yes AP 1986/04/28 FRESENIUS KABI USA
090571 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2009/08/31 HOSPIRA INC
090808 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
090810 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2010/06/30 SAGENT PHARMS
091682 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2011/06/08 SANDOZ
202732 001 ANDA HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
202957 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2014/06/12 SHENZHEN TECHDOW
203851 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2017/11/30 MYLAN LABS LTD
211005 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2018/12/14 NANJING KING-FRIEND
211007 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2019/05/28 NANJING KING-FRIEND
205323 002 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2019/11/18 GLAND
214804 001 ANDA HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML Prescription No No AP 2020/12/29 BE PHARMS
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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