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=ANDA212993"
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
16714-131-01 16714-131 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloride Irinotecan hydrochloride INJECTION INTRAVENOUS 20201115 N/A ANDA ANDA212993 Northstar Rx LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-131-01) / 5 mL in 1 VIAL, SINGLE-DOSE
16714-027-01 16714-027 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloride Irinotecan hydrochloride INJECTION INTRAVENOUS 20201115 N/A ANDA ANDA212993 Northstar Rx LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-027-01) / 2 mL in 1 VIAL, SINGLE-DOSE
68083-382-01 68083-382 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloride Irinotecan hydrochloride INJECTION INTRAVENOUS 20191118 N/A ANDA ANDA212993 Gland Pharma Limited IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01) / 5 mL in 1 VIAL, SINGLE-DOSE
68083-381-01 68083-381 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloide Irinotecan hydrochloide INJECTION INTRAVENOUS 20191118 N/A ANDA ANDA212993 Gland Pharma Limited IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) / 2 mL in 1 VIAL, SINGLE-DOSE
68001-480-22 68001-480 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloide Irinotecan hydrochloide INJECTION INTRAVENOUS 20201214 N/A ANDA ANDA212993 BluePoint Laboratories IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE
68001-480-35 68001-480 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloide Irinotecan hydrochloide INJECTION INTRAVENOUS 20201214 N/A ANDA ANDA212993 BluePoint Laboratories IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSE
70700-169-22 70700-169 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloide Irinotecan hydrochloide INJECTION INTRAVENOUS 20191118 N/A ANDA ANDA212993 Xiromed LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (70700-169-22) / 2 mL in 1 VIAL, SINGLE-DOSE
70700-170-22 70700-170 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloride Irinotecan hydrochloride INJECTION INTRAVENOUS 20191118 N/A ANDA ANDA212993 Xiromed LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 CARTON (70700-170-22) / 5 mL in 1 VIAL, SINGLE-DOSE
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