药品注册申请号:019802
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 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No None 1992/07/20 1992/07/20 Discontinued
002 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML No No None 1992/07/20 Discontinued
003 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No None 1992/07/20 Discontinued
005 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No None 1992/07/20 Discontinued
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
2014/08/22 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2002/07/12 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2002/02/15 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/11/22 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1998/06/05 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1993/03/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1992/12/22 SUPPL-3(补充) Approval Labeling STANDARD
1992/12/02 SUPPL-2(补充) Approval Manufacturing (CMC) 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)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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