药品注册申请号:019952
申请类型:NDA (新药申请)
申请人:B BRAUN
申请人全名:B BRAUN MEDICAL 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 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 4,000 UNITS/100ML Yes Yes None 1992/07/20 1992/07/20 Prescription
004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML Yes Yes AP 1992/07/20 Prescription
005 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML Yes Yes AP 1992/07/20 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
2023/07/12 SUPPL-48(补充) Approval Labeling STANDARD
2018/11/03 SUPPL-38(补充) Approval Labeling STANDARD
2016/11/17 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2016/05/26 SUPPL-33(补充) Approval Labeling STANDARD
2014/08/22 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2013/08/30 SUPPL-31(补充) Approval Labeling STANDARD
2013/01/09 SUPPL-30(补充) Approval Labeling UNKNOWN
2011/12/23 SUPPL-26(补充) Approval Labeling STANDARD
2009/02/26 SUPPL-21(补充) Approval Labeling STANDARD
2004/04/13 SUPPL-12(补充) Approval Labeling STANDARD
2002/07/12 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2002/02/15 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2000/11/22 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/03/01 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1998/06/05 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1996/07/30 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1994/12/08 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1993/03/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1992/12/22 SUPPL-2(补充) Approval Labeling STANDARD
1992/07/20 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
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
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/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
019339 004 NDA HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML Prescription No No AP 1985/03/27 HOSPIRA
019952 004 NDA HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML Prescription Yes Yes AP 1992/07/20 B BRAUN
活性成分:HEPARIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:10,000 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
019339 002 NDA HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML Prescription No No AP 1985/03/27 HOSPIRA
019339 003 NDA HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML Prescription No No AP 1985/03/27 HOSPIRA
019952 005 NDA HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML Prescription Yes Yes AP 1992/07/20 B BRAUN
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