药品注册申请号:212093
申请类型:ANDA (仿制药申请)
申请人:LANNETT CO INC
申请人全名:LANNETT CO 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 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML No No AA 2020/11/02 2020/11/02 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
2020/11/02 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
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
与本品治疗等效的药品
活性成分:METHADONE HYDROCHLORIDE 剂型/给药途径:CONCENTRATE;ORAL 规格:10MG/ML 治疗等效代码:AA
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
017116 002 NDA METHADOSE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription Yes Yes AA Approved Prior to Jan 1, 1982 SPECGX LLC
089897 001 ANDA METHADONE HYDROCHLORIDE INTENSOL METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription No No AA 1988/09/06 HIKMA
040088 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription No No AA 1994/11/30 VISTAPHARM LLC
040180 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription No No AA 1998/04/30 HIKMA
207368 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription No No AA 2019/08/22 SPECGX LLC
212093 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE CONCENTRATE;ORAL 10MG/ML Prescription No No AA 2020/11/02 LANNETT CO INC
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药品NDC数据与药品包装、标签说明书
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