药品注册申请号:021703
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE CORP
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 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes No None 2006/10/25 2006/10/25 Discontinued
002 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2006/10/25 Prescription
003 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2006/10/25 Prescription
004 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2006/10/25 Prescription
005 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No None 2006/10/25 Discontinued
006 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2006/10/25 Prescription
007 PRISMASOL BK 0/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No None 2006/10/25 Discontinued
008 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No None 2006/10/25 Discontinued
009 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No None 2006/10/25 Discontinued
010 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes No None 2008/10/10 Discontinued
011 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes Yes None 2008/10/10 Prescription
012 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) No No None 2008/10/10 Discontinued
013 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes No None 2008/10/10 Discontinued
014 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2008/10/10 Prescription
015 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes None 2008/10/10 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
2023/05/02 SUPPL-23(补充) Approval Labeling STANDARD
2018/11/01 SUPPL-20(补充) Approval Labeling STANDARD
2017/06/30 SUPPL-18(补充) Approval Labeling STANDARD
2016/07/20 SUPPL-17(补充) Approval Labeling STANDARD
2016/02/10 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2015/12/15 SUPPL-16(补充) Approval Labeling STANDARD
2015/06/17 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2013/12/13 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2013/10/18 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2013/06/10 SUPPL-10(补充) Approval Labeling STANDARD
2012/04/13 SUPPL-8(补充) Approval Labeling STANDARD
2009/04/20 SUPPL-4(补充) Approval Manufacturing (CMC) N/A
2008/10/10 SUPPL-3(补充) Approval Manufacturing (CMC) N/A
2006/10/25 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD
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