药品注册申请号:216081
申请类型:ANDA (仿制药申请)
申请人:HENGRUI PHARMA
申请人全名:JIANGSU HENGRUI PHARMACEUTICALS CO LTD
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 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 18.1416GM/30ML (604.72MG/ML) No No AP 2023/09/08 2023/09/08 Prescription
002 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 39.3068GM/65ML (604.72MG/ML) No No AP 2023/09/08 Prescription
003 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) No No AP 2022/11/17 Prescription
004 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) No No AP 2022/11/17 Prescription
005 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) No No AP 2022/11/17 Prescription
006 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) No No AP 2022/11/17 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
2024/08/19 SUPPL-4(补充) Approval Labeling STANDARD
2023/09/08 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 2024/04/29
002 CGT 2024/04/29
与本品治疗等效的药品
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:18.1416GM/30ML (604.72MG/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
201277 004 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 18.1416GM/30ML (604.72MG/ML) Prescription Yes Yes AP 2011/03/14 BAYER HLTHCARE
216081 001 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 18.1416GM/30ML (604.72MG/ML) Prescription No No AP 2023/09/08 HENGRUI PHARMA
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:39.3068GM/65ML (604.72MG/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
201277 005 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 39.3068GM/65ML (604.72MG/ML) Prescription Yes Yes AP 2011/03/14 BAYER HLTHCARE
216081 002 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 39.3068GM/65ML (604.72MG/ML) Prescription No No AP 2023/09/08 HENGRUI PHARMA
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1.20944GM/2ML (604.72MG/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
215061 001 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) Prescription No No AP -- HENGRUI PHARMA
201277 006 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) Prescription Yes Yes AP 2013/12/18 BAYER HLTHCARE
216081 003 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) Prescription No No AP 2022/11/17 HENGRUI PHARMA
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:4.5354GM/7.5ML (604.72MG/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
215061 002 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) Prescription No No AP -- HENGRUI PHARMA
201277 001 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) Prescription Yes Yes AP 2011/03/14 BAYER HLTHCARE
216081 004 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) Prescription No No AP 2022/11/17 HENGRUI PHARMA
217480 001 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) Prescription No No AP 2023/03/15 HAINAN POLY PHARM
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:6.0472GM/10ML (604.72MG/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
215061 003 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) Prescription No No AP -- HENGRUI PHARMA
201277 002 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) Prescription Yes Yes AP 2011/03/14 BAYER HLTHCARE
216081 005 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) Prescription No No AP 2022/11/17 HENGRUI PHARMA
活性成分:GADOBUTROL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:9.0708GM/15ML (604.72MG/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
215061 004 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) Prescription No No AP -- HENGRUI PHARMA
201277 003 NDA GADAVIST GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) Prescription Yes Yes AP 2011/03/14 BAYER HLTHCARE
216081 006 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) Prescription No No AP 2022/11/17 HENGRUI PHARMA
217480 002 ANDA GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) Prescription No No AP 2023/03/15 HAINAN POLY PHARM
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