药品注册申请号:213330
申请类型:NDA (新药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 LABETALOL HYDROCHLORIDE IN DEXTROSE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 200MG/200ML (1MG/ML) Yes Yes None 2020/11/09 2020/11/09 Prescription
002 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/100ML (1MG/ML) Yes Yes None 2020/11/09 Prescription
003 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 200MG/200ML (1MG/ML) Yes Yes None 2020/11/09 Prescription
004 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 300MG/300ML (1MG/ML) Yes Yes None 2020/11/09 Prescription
005 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/2ML (5MG/ML) Yes No None 2022/03/18 Discontinued
006 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE SOLUTION;INTRAVENOUS 20MG/4ML (5MG/ML) Yes Yes None 2024/08/19 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/08/19 SUPPL-6(补充) Approval Manufacturing (CMC) N/A
2023/06/15 SUPPL-5(补充) Approval Labeling STANDARD
2022/03/18 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2020/11/09 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品治疗等效的药品
本品无治疗等效药品
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