美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=GADOBUTROL"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
GADOBUTROL 215061 001 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 1.20944GM/2ML (604.72MG/ML) No No 2022/11/17 2022/11/17 HENGRUI PHARMA Prescription
GADOBUTROL 215061 002 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) No No 2022/11/17 2022/11/17 HENGRUI PHARMA Prescription
GADOBUTROL 215061 003 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 6.0472GM/10ML (604.72MG/ML) No No 2022/11/17 2022/11/17 HENGRUI PHARMA Prescription
GADOBUTROL 215061 004 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) No No 2022/11/17 2022/11/17 HENGRUI PHARMA Prescription
GADOBUTROL 217480 001 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) No No 2023/03/15 2023/03/15 HAINAN POLY PHARM Prescription
GADOBUTROL 217480 002 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) No No 2023/03/15 2023/03/15 HAINAN POLY PHARM Prescription
GADOBUTROL 216081 001 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 18.1416GM/30ML (604.72MG/ML) No No 2023/09/08 2023/09/08 HENGRUI PHARMA Prescription
GADOBUTROL 216081 002 ANDA GADOBUTROL SOLUTION;INTRAVENOUS 39.3068GM/65ML (604.72MG/ML) No No 2023/09/08 2023/09/08 HENGRUI PHARMA Prescription
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