药品注册申请号：217648
申请类型：ANDA (仿制药申请)
申请人：GLAND PHARMA LTD
申请人全名：GLAND PHARMA LTD
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 ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML No No AP 2024/10/03 2024/10/03 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
2024/10/03 ORIG-1（原始申请） Approval STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:ISOPROTERENOL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.2MG/ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
206961 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No Yes AP 2017/08/02 NEXUS
210322 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Discontinued No No AP 2018/06/12 CIPLA
210106 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2018/06/18 AMPHASTAR PHARMS INC
210576 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2018/10/17 AMNEAL
211864 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Discontinued No No AP 2021/02/09 EUGIA PHARMA
210845 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2021/02/16 MICRO LABS
211237 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2021/05/19 AMRING PHARMS
212189 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2021/11/19 AVET LIFESCIENCES
212573 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Discontinued No No AP 2022/09/06 NORVIUM BIOSCIENCE
215542 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2022/09/20 PENN LIFE
214775 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Discontinued No No AP 2022/10/19 AM REGENT
215557 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Discontinued No No AP 2023/04/14 ZYDUS PHARMS
211703 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2023/04/26 HIKMA
211590 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2024/08/06 SOMERSET THERAPS LLC
217648 001 ANDA ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Prescription No No AP 2024/10/03 GLAND PHARMA LTD
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药品NDC数据与药品包装、标签说明书
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