药品注册申请号：020183
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 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT 1992/12/04 1992/12/04 Prescription
002 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT 1992/12/04 Prescription
003 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No None 1992/12/04 Discontinued
004 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT 1992/12/04 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
2023/06/05 SUPPL-29（补充） Approval Labeling STANDARD
2016/08/16 SUPPL-27（补充） Approval Labeling STANDARD
2015/09/01 SUPPL-26（补充） Approval Labeling STANDARD
2015/02/09 SUPPL-24（补充） Approval Labeling STANDARD
2014/09/30 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2013/04/26 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL-19（补充） Approval Labeling STANDARD
2007/08/23 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2005/08/09 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2005/08/09 SUPPL-11（补充） Approval Labeling STANDARD
2002/02/12 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2001/08/22 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1996/11/22 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1994/06/01 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1992/12/04 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:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML 治疗等效代码:AT
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
017512 012 NDA DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1989/01/10 BAXTER HLTHCARE
020183 001 NDA DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML 治疗等效代码:AT
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
017512 013 NDA DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1990/07/11 BAXTER HLTHCARE
020183 002 NDA DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML 治疗等效代码:AT
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
017512 015 NDA DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1990/07/11 BAXTER HLTHCARE
020183 004 NDA DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
更多信息
药品NDC数据与药品包装、标签说明书
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