美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA216986"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
67684-4250-1 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-2 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-3 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-4 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-5 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-6 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4250-7 67684-4250 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
67684-4232-1 67684-4232 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL in 1 CARTON (67684-4232-1) / 10 mL in 1 VIAL
67684-4232-2 67684-4232 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 10 VIAL in 1 CARTON (67684-4232-2) / 10 mL in 1 VIAL
67684-4242-1 67684-4242 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 SYRINGE in 1 CARTON (67684-4242-1) / 15 mL in 1 SYRINGE
67684-4242-2 67684-4242 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 10 SYRINGE in 1 CARTON (67684-4242-2) / 15 mL in 1 SYRINGE
67684-4231-1 67684-4231 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL in 1 CARTON (67684-4231-1) / 7.5 mL in 1 VIAL
67684-4231-2 67684-4231 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 10 VIAL in 1 CARTON (67684-4231-2) / 7.5 mL in 1 VIAL
67684-4241-1 67684-4241 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 SYRINGE in 1 CARTON (67684-4241-1) / 10 mL in 1 SYRINGE
67684-4241-2 67684-4241 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 10 SYRINGE in 1 CARTON (67684-4241-2) / 10 mL in 1 SYRINGE
0270-7025-40 0270-7025 HUMAN PRESCRIPTION DRUG Vueway Gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 BRACCO DIAGNOSTICS INC GADOPICLENOL 485.1 mg/mL 10 VIAL, SINGLE-DOSE in 1 CASE (0270-7025-40) / 7.5 mL in 1 VIAL, SINGLE-DOSE
67684-4233-1 67684-4233 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 1 VIAL in 1 CARTON (67684-4233-1) / 15 mL in 1 VIAL
67684-4233-2 67684-4233 HUMAN PRESCRIPTION DRUG ELUCIREM gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 Guerbet LLC GADOPICLENOL 485.1 mg/mL 10 VIAL in 1 CARTON (67684-4233-2) / 15 mL in 1 VIAL
0270-7015-46 0270-7015 HUMAN PRESCRIPTION DRUG Vueway Gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 BRACCO DIAGNOSTICS INC GADOPICLENOL 485.1 mg/mL 25 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-46) / 30 mL in 1 VIAL, SINGLE-DOSE
0270-7015-48 0270-7015 HUMAN PRESCRIPTION DRUG Vueway Gadopiclenol INJECTION INTRAVENOUS 20220921 N/A NDA NDA216986 BRACCO DIAGNOSTICS INC GADOPICLENOL 485.1 mg/mL 25 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-48) / 50 mL in 1 VIAL, SINGLE-DOSE
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