药品注册申请号：017512
申请类型：NDA (新药申请)
申请人：VANTIVE US HLTHCARE
申请人全名：VANTIVE US HEALTHCARE LLC
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 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1978/09/27 Approved Prior to Jan 1, 1982 Discontinued
002 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT Approved Prior to Jan 1, 1982 Prescription
005 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT Approved Prior to Jan 1, 1982 Prescription
006 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No AT Approved Prior to Jan 1, 1982 Prescription
007 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1984/07/09 Discontinued
008 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1984/07/09 Discontinued
009 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1984/07/09 Discontinued
010 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1985/11/18 Discontinued
011 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Yes No None 1985/11/18 Discontinued
012 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 1989/01/10 Prescription
013 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 1990/07/11 Prescription
014 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 AT 1990/07/11 Prescription
015 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 1990/07/11 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1978/09/27 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2016/12/09 SUPPL-125（补充） Approval ,Manufacturing (CMC) STANDARD
2016/08/16 SUPPL-123（补充） Approval Labeling-Package Insert STANDARD
2016/08/01 SUPPL-124（补充） Approval Manufacturing (CMC) STANDARD
2015/09/01 SUPPL-122（补充） Approval Labeling-Package Insert STANDARD
2015/07/29 SUPPL-121（补充） Approval Manufacturing (CMC) STANDARD
2015/07/29 SUPPL-120（补充） Approval Manufacturing (CMC) STANDARD
2015/05/22 SUPPL-119（补充） Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL-118（补充） Approval Labeling-Package Insert STANDARD
2014/09/30 SUPPL-117（补充） Approval Manufacturing (CMC) STANDARD
2013/04/26 SUPPL-116（补充） Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL-113（补充） Approval Labeling-Package Insert STANDARD
2008/12/19 SUPPL-108（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2005/08/09 SUPPL-106（补充） Approval Labeling STANDARD
2005/08/09 SUPPL-104（补充） Approval Labeling STANDARD
2002/09/20 SUPPL-99（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/08/22 SUPPL-98（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/09/20 SUPPL-97（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/04/29 SUPPL-96（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/01/17 SUPPL-95（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1996/07/02 SUPPL-94（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1995/07/21 SUPPL-89（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/09/30 SUPPL-92（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/07/01 SUPPL-91（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/02/18 SUPPL-93（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/06/14 SUPPL-85（补充） Approval Manufacturing (CMC) STANDARD
1992/11/23 SUPPL-88（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/06/12 SUPPL-84（补充） Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-86（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/02/15 SUPPL-82（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/11/28 SUPPL-83（补充） Approval Labeling
1990/07/11 SUPPL-81（补充） Approval Labeling
1990/07/11 SUPPL-80（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1989/10/16 SUPPL-73（补充） Approval Labeling
1989/10/16 SUPPL-72（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-79（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/01/12 SUPPL-78（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/01/10 SUPPL-77（补充） Approval Labeling
1989/01/10 SUPPL-76（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1987/07/25 SUPPL-75（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/05/28 SUPPL-71（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/01/14 SUPPL-74（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/09/04 SUPPL-69（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1986/05/27 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL-66（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/11/18 SUPPL-68（补充） Approval Labeling
1985/11/18 SUPPL-67（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/08/29 SUPPL-62（补充） Approval Labeling
1985/08/29 SUPPL-61（补充） Approval Labeling
1985/08/28 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/08/28 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/07/16 SUPPL-64（补充） Approval Labeling
1985/07/16 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/07/16 SUPPL-18（补充） Approval Labeling
1985/07/16 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/06/13 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/04/15 SUPPL-65（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/04/10 SUPPL-58（补充） Approval Labeling
1985/01/24 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/09/22 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/07/09 SUPPL-53（补充） Approval Labeling
1984/07/09 SUPPL-52（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/03/16 SUPPL-44（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/28 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/11/07 SUPPL-49（补充） Approval Labeling
1983/11/07 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/12/08 SUPPL-41（补充） Approval Labeling
1982/12/08 SUPPL-40（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/12/08 SUPPL-39（补充） Approval Labeling
1982/12/08 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/12/03 SUPPL-37（补充） Approval Labeling
1982/06/03 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/16 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/09 SUPPL-32（补充） Approval Labeling
1982/04/09 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/16 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/12/21 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/12/15 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/20 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/13 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/10/05 SUPPL-25（补充） Approval Labeling
1981/10/05 SUPPL-24（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1981/08/26 SUPPL-28（补充） Approval Labeling
1981/06/29 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/04/16 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/21 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/08/07 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/08/06 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/31 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/28 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/18 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/02 SUPPL-13（补充） Approval Labeling
1980/06/02 SUPPL-12（补充） Approval Labeling
1980/06/02 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/02 SUPPL-9（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1980/06/02 SUPPL-8（补充） Approval Labeling
1980/06/02 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/30 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/08/02 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/02/27 SUPPL-3（补充） Approval Labeling
1978/11/21 SUPPL-1（补充） Approval Manufacturing (CMC)-Formulation 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:25.7MG/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 004 NDA DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT Approved Prior to Jan 1, 1982 VANTIVE US HLTHCARE
018883 004 NDA DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 001 NDA DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 VANTIVE US HLTHCARE
>>>活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE; 剂型/给药途径:SOLUTION;INTRAPERITONEAL; 规格:25.7MG/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 005 NDA DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT Approved Prior to Jan 1, 1982 VANTIVE US HLTHCARE
018883 005 NDA DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 002 NDA DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 VANTIVE US HLTHCARE
>>>活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE; 剂型/给药途径:SOLUTION;INTRAPERITONEAL; 规格:25.7MG/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 006 NDA DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT Approved Prior to Jan 1, 1982 VANTIVE US HLTHCARE
018883 006 NDA DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 003 NDA DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription Yes No AT 1992/12/04 VANTIVE US 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;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 VANTIVE US 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 VANTIVE US 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 VANTIVE US 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 VANTIVE US 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;3.5GM/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 014 NDA 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 Prescription Yes No AT 1990/07/11 VANTIVE US 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 VANTIVE US 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 VANTIVE US HLTHCARE
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