药品注册申请号:201152
申请类型:NDA (新药申请)
申请人:BOEHRINGER INGELHEIM
申请人全名:BOEHRINGER INGELHEIM PHARMACEUTICALS 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 VIRAMUNE XR NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Yes No AB 2011/03/25 2011/03/25 Discontinued
002 VIRAMUNE XR NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 100MG Yes No AB;TBD 2012/11/08 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
2024/07/22 SUPPL-15(补充) Approval Labeling STANDARD
2022/06/10 SUPPL-14(补充) Approval Labeling STANDARD
2018/09/24 SUPPL-13(补充) Approval Labeling STANDARD
2017/03/27 SUPPL-10(补充) Approval Labeling STANDARD
2014/01/27 SUPPL-7(补充) Approval Labeling STANDARD
2012/11/08 SUPPL-4(补充) Approval Efficacy STANDARD
2012/09/28 SUPPL-5(补充) Approval Efficacy STANDARD
2011/11/09 SUPPL-2(补充) Approval Labeling STANDARD
2011/05/06 SUPPL-1(补充) Approval REMS N/A
2011/03/25 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
001 8460704 2029/03/12 U-1409 2013/06/21 PDF格式
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 NDF 2014/03/25**本条是由Drugfuture回溯的历史信息**
NPP 2015/11/08**本条是由Drugfuture回溯的历史信息**
002 NDF 2014/03/25**本条是由Drugfuture回溯的历史信息**
NPP 2015/11/08**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:NEVIRAPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:400MG 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
201152 001 NDA VIRAMUNE XR NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Discontinued Yes No AB 2011/03/25 BOEHRINGER INGELHEIM
203411 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2014/04/03 SANDOZ
205651 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2014/10/27 MYLAN
204621 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Discontinued No No AB 2015/07/10 ALVOGEN
207698 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Discontinued No No AB 2017/02/28 AUROBINDO PHARMA
206879 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No Yes AB 2017/10/06 MACLEODS PHARMS LTD
活性成分:NEVIRAPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:100MG 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
201152 002 NDA VIRAMUNE XR NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued Yes No AB 2012/11/08 BOEHRINGER INGELHEIM
204621 002 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB 2015/11/09 ALVOGEN
208616 001 ANDA NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB 2016/11/23 AUROBINDO PHARMA
活性成分:NEVIRAPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:100MG 治疗等效代码:TBD
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
201152 002 NDA VIRAMUNE XR NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued Yes No TBD 2012/11/08 BOEHRINGER INGELHEIM
更多信息
药品NDC数据与药品包装、标签说明书
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