药品注册申请号:214805
申请类型:ANDA (仿制药申请)
申请人:MILLA PHARMS
申请人全名:MILLA PHARMACEUTICALS INC
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 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 100MEQ/50ML (2MEQ/ML) No No AP 2021/05/04 2021/05/04 Prescription
002 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) No No AP 2023/08/25 Prescription
003 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 200MEQ/100ML (2MEQ/ML) No No AP 2021/05/04 Prescription
004 SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 40MEQ/20ML (2MEQ/ML) No No AP 2024/01/22 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
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
2024/01/22 SUPPL-5(补充) Approval Manufacturing (CMC) UNKNOWN
2021/05/04 ORIG-1(原始申请) Approval 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
001 CGT 2022/01/03**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:SODIUM ACETATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:100MEQ/50ML (2MEQ/ML) 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
018893 002 NDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 100MEQ/50ML (2MEQ/ML) Prescription Yes Yes AP 2014/09/02 HOSPIRA
214805 001 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 100MEQ/50ML (2MEQ/ML) Prescription No No AP 2021/05/04 MILLA PHARMS
216920 002 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 100MEQ/50ML (2MEQ/ML) Prescription No No AP 2024/03/15 HIKMA
活性成分:SODIUM ACETATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:400MEQ/100ML (4MEQ/ML) 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
206687 001 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) Prescription No Yes AP 2017/10/30 FRESENIUS KABI USA
214805 002 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) Prescription No No AP 2023/08/25 MILLA PHARMS
活性成分:SODIUM ACETATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:200MEQ/100ML (2MEQ/ML) 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
018893 003 NDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 200MEQ/100ML (2MEQ/ML) Prescription Yes Yes AP 2014/09/02 HOSPIRA
214805 003 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 200MEQ/100ML (2MEQ/ML) Prescription No No AP 2021/05/04 MILLA PHARMS
216920 003 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 200MEQ/100ML (2MEQ/ML) Prescription No No AP 2024/03/15 HIKMA
活性成分:SODIUM ACETATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:40MEQ/20ML (2MEQ/ML) 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
018893 001 NDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 40MEQ/20ML (2MEQ/ML) Prescription Yes Yes AP 1983/05/04 HOSPIRA
214805 004 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 40MEQ/20ML (2MEQ/ML) Prescription No No AP 2024/01/22 MILLA PHARMS
216920 001 ANDA SODIUM ACETATE SODIUM ACETATE SOLUTION;INTRAVENOUS 40MEQ/20ML (2MEQ/ML) Prescription No No AP 2024/03/15 HIKMA
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