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=NDA213330"
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
0143-9363-10 0143-9363 HUMAN PRESCRIPTION DRUG Labetalol HCl in Sodium Chloride LABETALOL HYDROCHLORIDE INJECTION INTRAVENOUS 20201109 N/A NDA NDA213330 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 1 mg/mL 10 BAG in 1 BOX (0143-9363-10) / 100 mL in 1 BAG (0143-9363-01)
0143-9364-10 0143-9364 HUMAN PRESCRIPTION DRUG Labetalol HCl in Sodium Chloride LABETALOL HYDROCHLORIDE INJECTION INTRAVENOUS 20201109 N/A NDA NDA213330 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 1 mg/mL 10 BAG in 1 BOX (0143-9364-10) / 200 mL in 1 BAG (0143-9364-01)
0143-9365-10 0143-9365 HUMAN PRESCRIPTION DRUG Labetalol HCl in Sodium Chloride LABETALOL HYDROCHLORIDE INJECTION INTRAVENOUS 20201109 N/A NDA NDA213330 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 1 mg/mL 10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01)
0143-9366-10 0143-9366 HUMAN PRESCRIPTION DRUG Labetalol HCl in Dextrose Labetalol Hydrochloride INJECTION INTRAVENOUS 20201109 N/A NDA NDA213330 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 1 mg/mL 10 BAG in 1 BOX (0143-9366-10) / 200 mL in 1 BAG (0143-9366-01)
0641-6252-10 0641-6252 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 20220318 N/A NDA NDA213330 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 5 mg/mL 10 SYRINGE, GLASS in 1 CARTON (0641-6252-10) / 2 mL in 1 SYRINGE, GLASS
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