药品注册申请号:091149
申请类型:ANDA (仿制药申请)
申请人:TEVA PHARMS USA
申请人全名:TEVA PHARMACEUTICALS USA
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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No None 2014/09/08 2014/09/08 Discontinued
002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No None 2014/09/08 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/07 SUPPL 14 Approval Labeling STANDARD
2018/10/31 SUPPL 13 Approval REMS
2018/02/01 SUPPL 12 Approval Labeling STANDARD
2018/02/01 SUPPL 11 Approval Labeling STANDARD
2018/01/31 SUPPL 10 Approval Labeling STANDARD
2017/05/23 SUPPL 9 Approval REMS
2016/12/16 SUPPL 8 Approval Labeling STANDARD
2016/12/16 SUPPL 6 Approval Labeling STANDARD
2016/07/07 SUPPL 3 Approval REMS
2015/02/12 SUPPL 1 Approval REMS
2015/02/05 SUPPL 2 Approval Labeling STANDARD
2014/09/08 ORIG 1 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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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