药品注册申请号:020972
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB CO
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001 SUSTIVA EFAVIRENZ CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1998/09/17 1998/09/17 Discontinued
002 SUSTIVA EFAVIRENZ CAPSULE;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1998/09/17 Discontinued
003 SUSTIVA EFAVIRENZ CAPSULE;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1998/09/17 Discontinued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
2023/11/08 SUPPL-59(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-57(补充) Approval Labeling STANDARD
2017/10/10 SUPPL-56(补充) Approval Labeling STANDARD
2017/01/30 SUPPL-54(补充) Approval Labeling STANDARD
2016/10/12 SUPPL-53(补充) Approval Labeling STANDARD
2016/08/31 SUPPL-51(补充) Approval Labeling STANDARD
2016/06/03 SUPPL-50(补充) Approval Manufacturing (CMC) PRIORITY
2016/03/31 SUPPL-49(补充) Approval Labeling STANDARD
2015/03/27 SUPPL-48(补充) Approval Labeling STANDARD
2014/08/14 SUPPL-47(补充) Approval Manufacturing (CMC) PRIORITY
2014/05/23 SUPPL-46(补充) Approval Labeling STANDARD
2014/01/22 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
2014/01/15 SUPPL-44(补充) Approval Manufacturing (CMC) PRIORITY
2013/05/02 SUPPL-43(补充) Approval Efficacy PRIORITY
2012/08/10 SUPPL-42(补充) Approval Labeling 901 REQUIRED
2012/06/22 SUPPL-41(补充) Approval Labeling STANDARD
2011/12/19 SUPPL-40(补充) Approval Labeling UNKNOWN
2011/09/26 SUPPL-38(补充) Approval Labeling UNKNOWN
2010/11/30 SUPPL-36(补充) Approval Labeling STANDARD
2010/03/31 SUPPL-35(补充) Approval Labeling UNKNOWN
2009/09/23 SUPPL-33(补充) Approval Labeling STANDARD
2009/03/11 SUPPL-31(补充) Approval Labeling STANDARD
2008/08/18 SUPPL-30(补充) Approval Labeling STANDARD
2007/01/24 SUPPL-29(补充) Approval Labeling STANDARD
2006/03/28 SUPPL-27(补充) Approval Labeling STANDARD
2005/04/20 SUPPL-26(补充) Approval Labeling STANDARD
2004/10/22 SUPPL-24(补充) Approval Labeling STANDARD
2004/08/13 SUPPL-22(补充) Approval Efficacy UNKNOWN
2003/11/13 SUPPL-21(补充) Approval Labeling STANDARD
2003/06/10 SUPPL-19(补充) Approval Labeling STANDARD
2003/06/10 SUPPL-18(补充) Approval Labeling STANDARD
2003/01/29 SUPPL-16(补充) Approval Labeling STANDARD
2002/09/20 SUPPL-17(补充) Approval Labeling STANDARD
2002/03/01 SUPPL-7(补充) Approval Labeling STANDARD
2002/02/28 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/21 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
2001/10/16 SUPPL-13(补充) Approval Labeling STANDARD
2001/05/16 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/12 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
2000/11/14 SUPPL-6(补充) Approval Labeling STANDARD
2000/05/31 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
2000/05/31 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/18 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/09 SUPPL-1(补充) Approval Efficacy STANDARD
1999/08/27 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1998/09/17 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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
001 5519021 2013/05/21 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5519021*PED 2013/11/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169 2014/09/02 U-257 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169*PED 2015/03/02 PDF格式**本条是由Drugfuture回溯的历史信息**
5811423 2012/08/07 Y Y U-256 PDF格式**本条是由Drugfuture回溯的历史信息**
6238695 2019/04/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6238695*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133 2019/04/06 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6639071 2018/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6639071*PED 2018/08/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6939964 2018/01/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6939964*PED 2018/07/20 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5519021 2013/05/21 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5519021*PED 2013/11/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169 2014/09/02 U-257 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169*PED 2015/03/02 PDF格式**本条是由Drugfuture回溯的历史信息**
5811423 2012/08/07 Y Y U-256 PDF格式**本条是由Drugfuture回溯的历史信息**
6238695 2019/04/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6238695*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133 2019/04/06 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6639071 2018/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6639071*PED 2018/08/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6939964 2018/01/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6939964*PED 2018/07/20 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5519021 2013/05/21 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5519021*PED 2013/11/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169 2014/09/02 U-257 PDF格式**本条是由Drugfuture回溯的历史信息**
5663169*PED 2015/03/02 PDF格式**本条是由Drugfuture回溯的历史信息**
5811423 2012/08/07 Y Y U-256 PDF格式**本条是由Drugfuture回溯的历史信息**
6238695 2019/04/06 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6238695*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133 2019/04/06 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
6555133*PED 2019/10/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6639071 2018/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6639071*PED 2018/08/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6939964 2018/01/20 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6939964*PED 2018/07/20 PDF格式**本条是由Drugfuture回溯的历史信息**
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 NPP 2016/05/02**本条是由Drugfuture回溯的历史信息**
PED 2016/11/02**本条是由Drugfuture回溯的历史信息**
003 NPP 2016/05/02**本条是由Drugfuture回溯的历史信息**
PED 2016/11/02**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:EFAVIRENZ 剂型/给药途径:CAPSULE;ORAL 规格:50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB
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
020972 001 NDA SUSTIVA EFAVIRENZ CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1998/09/17 BRISTOL MYERS SQUIBB
活性成分:EFAVIRENZ 剂型/给药途径:CAPSULE;ORAL 规格:200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB
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
020972 003 NDA SUSTIVA EFAVIRENZ CAPSULE;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1998/09/17 BRISTOL MYERS SQUIBB
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