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=ANDA217480"
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
70436-216-51 70436-216 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-51) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-77)
70436-212-54 70436-212 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20231020 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
70436-212-80 70436-212 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20231020 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
70436-216-81 70436-216 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-81) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-36)
70436-213-82 70436-213 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33)
70436-217-50 70436-217 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-50) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-78)
70436-217-80 70436-217 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-80) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-38)
70436-214-54 70436-214 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20231020 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)
70436-214-80 70436-214 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20231020 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)
70436-218-84 70436-218 HUMAN PRESCRIPTION DRUG gadobutrol gadobutrol INJECTION INTRAVENOUS 20250416 N/A ANDA ANDA217480 Slate Run Pharmaceuticals, LLC GADOBUTROL 604.72 mg/mL 3 VIAL, SINGLE-DOSE in 1 CARTON (70436-218-84) / 2 mL in 1 VIAL, SINGLE-DOSE (70436-218-30)
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