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=ANDA214533"
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
72603-146-01 72603-146 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20230428 N/A ANDA ANDA214533 NorthStar Rx LLC LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL, MULTI-DOSE in 1 CARTON (72603-146-01) / 20 mL in 1 VIAL, MULTI-DOSE
65145-125-01 65145-125 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20250214 N/A ANDA ANDA214533 Caplin Steriles Limited LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL, MULTI-DOSE in 1 CARTON (65145-125-01) / 40 mL in 1 VIAL, MULTI-DOSE
65145-124-01 65145-124 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20250214 N/A ANDA ANDA214533 Caplin Steriles Limited LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL, MULTI-DOSE in 1 CARTON (65145-124-01) / 20 mL in 1 VIAL, MULTI-DOSE
25021-317-20 25021-317 HUMAN PRESCRIPTION DRUG labetalol hydrochloride labetalol hydrochloride INJECTION, SOLUTION INTRAVENOUS 20220901 N/A ANDA ANDA214533 Sagent Pharmaceuticals LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL
25021-317-40 25021-317 HUMAN PRESCRIPTION DRUG labetalol hydrochloride labetalol hydrochloride INJECTION, SOLUTION INTRAVENOUS 20220901 N/A ANDA ANDA214533 Sagent Pharmaceuticals LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL
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