药品注册申请号：077234
申请类型：ANDA (仿制药申请)
申请人：HIKMA FARMACEUTICA
申请人全名：HIKMA FARMACEUTICA (PORTUGAL) SA
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 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No AP 2008/02/25 2008/02/25 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
2009/07/10 SUPPL-5（补充） Approval Labeling
2008/02/25 ORIG-1（原始申请） Approval
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:AMIODARONE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/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
075761 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No Yes AP 2002/10/15 FRESENIUS KABI USA
076217 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No Yes AP 2002/10/15 MYLAN INSTITUTIONAL
077161 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No Yes AP 2005/04/20 GLAND PHARMA LTD
077234 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No No AP 2008/02/25 HIKMA FARMACEUTICA
077610 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No No AP 2008/10/30 ACELLA
077834 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No No AP 2008/10/30 ACELLA
203884 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Discontinued No No AP 2013/11/25 HOSPIRA
204550 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Discontinued No No AP 2017/10/25 EUGIA PHARMA
218253 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Prescription No No AP 2024/09/11 ZHEJIANG POLY PHARM
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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