药品注册申请号：017378
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 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Yes Yes AP 1979/02/02 Approved Prior to Jan 1, 1982 Prescription
002 PLASMA-LYTE A IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Yes Yes AP 1982/11/22 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
1979/02/02 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
2019/08/05 SUPPL-75（补充） Approval Labeling-Package Insert STANDARD
2016/04/28 SUPPL-72（补充） Approval Manufacturing (CMC) STANDARD
2016/01/26 SUPPL-71（补充） Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL-69（补充） Approval Manufacturing (CMC) STANDARD
2013/09/11 SUPPL-68（补充） Approval Labeling-Package Insert STANDARD
2009/01/27 SUPPL-65（补充） Approval Labeling STANDARD
2002/04/03 SUPPL-55（补充） Approval Labeling STANDARD
2001/08/14 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2001/02/01 SUPPL-58（补充） Approval Labeling STANDARD
1999/11/24 SUPPL-57（补充） Approval Manufacturing (CMC) STANDARD
1999/02/04 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/29 SUPPL-54（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/09/30 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/02/18 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/04/29 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/03/26 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/02/15 SUPPL-47（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/05/24 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/07/25 SUPPL-45（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/05/28 SUPPL-44（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/02/27 SUPPL-42（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/08/28 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/08/28 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/06/13 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/04/15 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/01/26 SUPPL-40（补充） Approval Labeling
1985/01/24 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/01/19 SUPPL-35（补充） Approval Labeling
1984/09/22 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/16 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/28 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/07/11 SUPPL-25（补充） Approval Labeling
1983/07/11 SUPPL-24（补充） Approval Labeling
1982/11/22 SUPPL-30（补充） Approval Labeling
1982/11/22 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/03 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/16 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/16 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/12/21 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/20 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/09/03 SUPPL-17（补充） Approval Labeling
1981/09/03 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/08/26 SUPPL-19（补充） Approval Labeling
1981/06/29 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/04/16 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/21 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/08/07 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/31 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/28 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/18 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/30 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/02/25 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/08/02 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/06/14 SUPPL-2（补充） Approval Manufacturing (CMC)-Control 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
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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
无
与本品治疗等效的药品
>>>活性成分:MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML; 治疗等效代码:AP<<<
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
017378 001 NDA PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017378 002 NDA PLASMA-LYTE A IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription Yes Yes AP 1982/11/22 BAXTER HLTHCARE
215371 001 ANDA MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription No No AP 2022/06/08 FRESENIUS KABI USA
215370 001 ANDA MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription No No AP 2022/06/29 FRESENIUS KABI USA
>>>活性成分:MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML; 治疗等效代码:AP<<<
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
017378 001 NDA PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017378 002 NDA PLASMA-LYTE A IN PLASTIC CONTAINER MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription Yes Yes AP 1982/11/22 BAXTER HLTHCARE
215371 001 ANDA MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription No No AP 2022/06/08 FRESENIUS KABI USA
215370 001 ANDA MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML Prescription No No AP 2022/06/29 FRESENIUS KABI USA
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