药品注册申请号:211002
申请类型:ANDA (仿制药申请)
申请人:MEITHEAL
申请人全名:MEITHEAL 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 LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) No Yes AP 2019/08/16 2019/08/16 Prescription
002 LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) No No AP 2019/08/16 Discontinued
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
2023/09/22 SUPPL-3(补充) Approval Labeling STANDARD
2023/09/22 SUPPL-2(补充) Approval Labeling STANDARD
2019/08/16 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
与本品治疗等效的药品
活性成分:LEVOLEUCOVORIN CALCIUM 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 175MG BASE/17.5ML (EQ 10MG BASE/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
203563 001 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Prescription No No AP 2015/03/09 SANDOZ
207548 001 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Prescription No No AP 2017/09/08 AMNEAL
210892 001 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Prescription No No AP 2018/09/14 GLAND PHARMA LTD
211002 001 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Prescription No Yes AP 2019/08/16 MEITHEAL
217314 001 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Prescription No No AP 2023/05/22 HAINAN POLY PHARM
活性成分:LEVOLEUCOVORIN CALCIUM 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 250MG BASE/25ML (EQ 10MG BASE/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
210892 002 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Prescription No Yes AP 2018/09/14 GLAND PHARMA LTD
211002 002 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Discontinued No No AP 2019/08/16 MEITHEAL
217314 002 ANDA LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM SOLUTION;INTRAVENOUS EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Prescription No No AP 2023/05/22 HAINAN POLY PHARM
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