药品注册申请号:019395
申请类型:NDA (新药申请)
申请人:FRESENIUS MEDCL
申请人全名:FRESENIUS MEDICAL CARE NORTH AMERICA
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 INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100ML No No None 1986/03/26 1986/03/26 Discontinued
002 INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100ML No No None 1986/03/26 Discontinued
003 INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100ML No No None 1986/03/26 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
1999/09/27 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1996/07/03 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1986/03/26 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
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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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