药品注册申请号:017512
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 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
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/12/09 SUPPL 125 Approval Manufacturing (CMC) STANDARD
2016/08/16 SUPPL 123 Approval Labeling STANDARD
2016/08/01 SUPPL 124 Approval Manufacturing (CMC) STANDARD
2015/09/01 SUPPL 122 Approval Labeling STANDARD
2015/07/29 SUPPL 121 Approval Manufacturing (CMC) STANDARD
2015/07/29 SUPPL 120 Approval Manufacturing (CMC) STANDARD
2015/05/22 SUPPL 119 Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL 118 Approval Labeling STANDARD
2014/09/30 SUPPL 117 Approval Manufacturing (CMC) STANDARD
2013/04/26 SUPPL 116 Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL 113 Approval Labeling STANDARD
2008/12/19 SUPPL 108 Approval Manufacturing (CMC) N/A
2005/08/09 SUPPL 106 Approval Labeling STANDARD
2005/08/09 SUPPL 104 Approval Labeling STANDARD
2002/09/20 SUPPL 99 Approval Manufacturing (CMC) STANDARD
2001/08/22 SUPPL 98 Approval Manufacturing (CMC) STANDARD
2000/09/20 SUPPL 97 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1997/01/17 SUPPL 95 Approval Manufacturing (CMC) STANDARD
1996/07/02 SUPPL 94 Approval Manufacturing (CMC) STANDARD
1995/07/21 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 92 Approval Manufacturing (CMC) STANDARD
1994/07/01 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1993/06/14 SUPPL 85 Approval Manufacturing (CMC) STANDARD
1992/11/23 SUPPL 88 Approval Manufacturing (CMC) STANDARD
1992/06/12 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL 86 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1990/11/28 SUPPL 83 Approval Labeling
1990/07/11 SUPPL 81 Approval Labeling
1990/07/11 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1989/10/16 SUPPL 73 Approval Labeling
1989/10/16 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1989/01/10 SUPPL 77 Approval Labeling
1989/01/10 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 75 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1987/01/14 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1986/09/04 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1986/05/27 SUPPL 70 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1985/11/18 SUPPL 68 Approval Labeling
1985/11/18 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1985/08/29 SUPPL 62 Approval Labeling
1985/08/29 SUPPL 61 Approval Labeling
1985/08/28 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1985/07/16 SUPPL 64 Approval Labeling
1985/07/16 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1985/07/16 SUPPL 18 Approval Labeling
1985/07/16 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1985/04/10 SUPPL 58 Approval Labeling
1985/01/24 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1984/07/09 SUPPL 53 Approval Labeling
1984/07/09 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1983/11/07 SUPPL 49 Approval Labeling
1983/11/07 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1982/12/08 SUPPL 41 Approval Labeling
1982/12/08 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1982/12/08 SUPPL 39 Approval Labeling
1982/12/08 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1982/12/03 SUPPL 37 Approval Labeling
1982/06/03 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1982/04/09 SUPPL 32 Approval Labeling
1982/04/09 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1982/02/16 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1981/12/15 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1981/11/13 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1981/10/05 SUPPL 25 Approval Labeling
1981/10/05 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 28 Approval Labeling
1981/06/29 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1980/06/02 SUPPL 13 Approval Labeling
1980/06/02 SUPPL 12 Approval Labeling
1980/06/02 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1980/06/02 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1980/06/02 SUPPL 8 Approval Labeling
1980/06/02 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1979/02/27 SUPPL 3 Approval Labeling
1978/11/21 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1978/09/27 ORIG 1 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: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 BAXTER 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 No No 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 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: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 BAXTER 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 No No 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 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: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 BAXTER 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 No No 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 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;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;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 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
©2006-2019 DrugFuture->U.S. FDA Drugs Database