药品注册申请号:077142
申请类型:ANDA (仿制药申请)
申请人:SPECGX LLC
申请人全名:SPECGX LLC
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 TABLET, FOR SUSPENSION;ORAL 40MG No No AA 2005/07/12 2005/07/12 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
2018/09/18 SUPPL-17(补充) Approval REMS
2014/12/13 SUPPL-11(补充) Approval Labeling STANDARD
2014/11/05 SUPPL-8(补充) Approval Manufacturing (CMC)
2009/11/09 SUPPL-6(补充) Approval Labeling
2007/04/04 SUPPL-5(补充) Approval Labeling
2006/09/20 SUPPL-2(补充) Approval Labeling
2006/03/23 SUPPL-3(补充) Approval Labeling
2005/07/12 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
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:TABLET, FOR SUSPENSION;ORAL 规格:40MG 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
017058 001 NDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION;ORAL 40MG Prescription Yes Yes AA Approved Prior to Jan 1, 1982 HIKMA
074184 001 ANDA METHADOSE METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION;ORAL 40MG Prescription No No AA 1993/04/29 SPECGX LLC
075082 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION;ORAL 40MG Prescription No No AA 1998/03/25 VISTAPHARM
077142 001 ANDA METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION;ORAL 40MG Prescription No No AA 2005/07/12 SPECGX LLC
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药品NDC数据与药品包装、标签说明书
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