药品注册申请号:020733
申请类型:NDA (新药申请)
申请人:INDIVIOR
申请人全名:INDIVIOR 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 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2002/10/08 2002/10/08 Discontinued
002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2002/10/08 Discontinued
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
2022/06/17 SUPPL-32(补充) Approval Labeling STANDARD
2022/06/17 SUPPL-31(补充) Approval Labeling STANDARD
2022/05/03 SUPPL-30(补充) Approval REMS N/A
2021/11/19 SUPPL-29(补充) Approval REMS N/A
2021/03/04 SUPPL-28(补充) Approval Labeling STANDARD
2020/03/02 SUPPL-27(补充) Approval REMS N/A ;Orphan
2019/10/31 SUPPL-24(补充) Approval Labeling STANDARD ;Orphan
2019/10/07 SUPPL-26(补充) Approval Labeling STANDARD ;Orphan
2018/10/26 SUPPL-25(补充) Approval REMS N/A ;Orphan
2018/06/11 SUPPL-23(补充) Approval REMS N/A ;Orphan
2018/02/01 SUPPL-22(补充) Approval Labeling STANDARD
2017/09/19 SUPPL-21(补充) Approval REMS N/A
2017/09/07 SUPPL-20(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-19(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-18(补充) Approval Labeling STANDARD
2016/07/07 SUPPL-17(补充) Approval REMS N/A
2015/09/22 SUPPL-16(补充) Approval REMS N/A
2014/12/11 SUPPL-14(补充) Approval Labeling STANDARD
2013/10/23 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
2013/08/08 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
2011/12/22 SUPPL-8(补充) Approval Labeling UNKNOWN
2011/12/22 SUPPL-7(补充) Approval REMS N/A
2006/10/04 SUPPL-3(补充) Approval Labeling STANDARD
2002/10/08 ORIG-1(原始申请) Approval Type 4 - New Combination PRIORITY ;Orphan
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
001 ODE 2009/10/08**本条是由Drugfuture回溯的历史信息**
002 ODE 2009/10/08**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
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