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=ANDA075303"
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
0143-9320-01 0143-9320 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 19991129 N/A ANDA ANDA075303 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 BOX, UNIT-DOSE (0143-9320-01) / 20 mL in 1 VIAL
72572-350-01 72572-350 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 20191121 N/A ANDA ANDA075303 Civica, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 BOX, UNIT-DOSE (72572-350-01) / 20 mL in 1 VIAL
0143-9623-01 0143-9623 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 19991129 N/A ANDA ANDA075303 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 BOX, UNIT-DOSE (0143-9623-01) / 40 mL in 1 VIAL
51662-1602-9 51662-1602 HUMAN PRESCRIPTION DRUG LABETALOL HCl LABETALOL HCl INJECTION INTRAVENOUS 20221001 N/A ANDA ANDA075303 HF Acquisition Co LLC, DBA HealthFirst LABETALOL HYDROCHLORIDE 5 mg/mL 20 mL in 1 VIAL (51662-1602-9)
51662-1602-1 51662-1602 HUMAN PRESCRIPTION DRUG LABETALOL HCl LABETALOL HCl INJECTION INTRAVENOUS 20220829 N/A ANDA ANDA075303 HF Acquisition Co LLC, DBA HealthFirst LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1) / 20 mL in 1 VIAL
0143-9622-01 0143-9622 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 19991129 N/A ANDA ANDA075303 Hikma Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 5 mg/mL 1 VIAL in 1 BOX, UNIT-DOSE (0143-9622-01) / 20 mL in 1 VIAL
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