药品注册申请号：018609
申请类型：NDA (新药申请)
申请人：BAXTER HLTHCARE
申请人全名：BAXTER HEALTHCARE CORP
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 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML No No AP 1982/04/28 1982/04/28 Prescription
002 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 200 UNITS/100ML No No AP 1982/04/28 Prescription
003 HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 500 UNITS/100ML No No None 1982/04/28 Discontinued
004 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 2,000 UNITS/1000ML No No None -- 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
2022/01/03 SUPPL-58（补充） Approval Labeling STANDARD
2019/07/15 SUPPL-54（补充） Approval Labeling STANDARD
2016/07/25 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
2015/08/18 SUPPL-49（补充） Approval Manufacturing (CMC) STANDARD
2012/02/27 SUPPL-42（补充） Approval Labeling STANDARD
2010/08/13 SUPPL-44（补充） Approval Labeling UNKNOWN
2001/08/21 SUPPL-35（补充） Approval Labeling STANDARD
2001/08/21 SUPPL-33（补充） Approval Labeling STANDARD
2001/08/14 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1999/11/23 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1999/06/01 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1997/05/20 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
1996/09/17 SUPPL-31（补充） Approval Labeling STANDARD
1994/09/14 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1994/03/10 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1993/04/15 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1991/03/04 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1991/02/01 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1990/07/26 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1989/11/08 SUPPL-21（补充） Approval Labeling
1989/11/08 SUPPL-15（补充） Approval Labeling
1989/11/08 SUPPL-10（补充） Approval Labeling
1989/08/24 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1987/04/29 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1986/12/01 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1986/12/01 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1985/09/20 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1985/09/20 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1984/10/16 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1984/08/03 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1984/03/06 SUPPL-11（补充） Approval Labeling
1984/03/06 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1984/03/06 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1984/03/06 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1982/08/09 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1982/08/09 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1982/06/29 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1982/04/28 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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: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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