药品注册申请号：018916
申请类型：NDA (新药申请)
申请人：HOSPIRA
申请人全名：HOSPIRA 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 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/100ML No No None 1984/01/31 1984/01/31 Discontinued
002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML No No None 1984/01/31 Discontinued
003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No None 1984/01/31 Discontinued
004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM INJECTABLE;INJECTION 100 UNITS/ML No No None 1984/01/31 Discontinued
005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML No No None 1984/01/31 Discontinued
006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML Yes Yes None 1984/01/31 Prescription
007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML Yes Yes None 1984/01/31 Prescription
008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML Yes Yes None 1984/01/31 Prescription
009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No None 1984/01/31 Discontinued
010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Yes Yes AP 1989/06/23 Prescription
011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Yes Yes AP 1989/06/23 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
1984/01/31 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
2025/11/19 SUPPL-83（补充） Approval Labeling-Package Insert STANDARD
2024/12/10 SUPPL-80（补充） Approval Labeling-Package Insert STANDARD
2024/10/24 SUPPL-79（补充） Approval Labeling-Package Insert STANDARD
2020/07/30 SUPPL-71（补充） Approval Labeling-Package Insert STANDARD
2019/09/04 SUPPL-63（补充） Approval Labeling-Container/Carton Labels STANDARD
2016/07/18 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
2016/04/05 SUPPL-69（补充） Approval Labeling-Package Insert STANDARD
2016/04/05 SUPPL-66（补充） Approval Labeling-Package Insert STANDARD
2015/04/14 SUPPL-68（补充） Approval Manufacturing (CMC) STANDARD
2015/03/03 SUPPL-67（补充） Approval Manufacturing (CMC) STANDARD
2014/01/15 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
2013/07/15 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
2013/02/12 SUPPL-60（补充） Approval Labeling-Package Insert STANDARD
2013/02/08 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
2012/11/30 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2011/12/23 SUPPL-57（补充） Approval Labeling-Package Insert STANDARD
1999/11/19 SUPPL-33（补充） Approval Labeling STANDARD
1998/10/27 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/08/25 SUPPL-28（补充） Approval Labeling STANDARD
1997/08/29 SUPPL-31（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/06/25 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1997/06/09 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1997/04/03 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1996/09/05 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1996/08/30 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-26（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1996/02/07 SUPPL-25（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1992/02/25 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1992/02/18 SUPPL-18（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/10/02 SUPPL-21（补充） Approval Labeling
1990/10/29 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/02/16 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/06/23 SUPPL-8（补充） Approval Efficacy-New Dosing Regimen
1988/10/24 SUPPL-12（补充） Approval Labeling
1987/08/21 SUPPL-7（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1986/10/29 SUPPL-6（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1986/08/08 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-4（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1985/10/29 SUPPL-3（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1985/04/16 SUPPL-2（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/09/24 SUPPL-1（补充） Approval Labeling
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:200 UNITS/100ML; 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
018609 001 NDA HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
018609 002 NDA HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
018916 010 NDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1989/06/23 HOSPIRA
018916 011 NDA HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1989/06/23 HOSPIRA
019953 001 NDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1992/07/20 B BRAUN
212441 001 ANDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 2020/07/24 FRESENIUS KABI USA
212441 002 ANDA HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 2020/07/24 FRESENIUS KABI USA
>>>活性成分:HEPARIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:200 UNITS/100ML; 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
018609 001 NDA HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
018609 002 NDA HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
018916 010 NDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1989/06/23 HOSPIRA
018916 011 NDA HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1989/06/23 HOSPIRA
019953 001 NDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription Yes Yes AP 1992/07/20 B BRAUN
212441 001 ANDA HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 2020/07/24 FRESENIUS KABI USA
212441 002 ANDA HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML Prescription No No AP 2020/07/24 FRESENIUS KABI USA
更多信息
药品NDC数据与药品包装、标签说明书
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