药品注册申请号:202073
申请类型:ANDA (仿制药申请)
申请人:LUPIN LTD
申请人全名:LUPIN LTD
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 DARUNAVIR DARUNAVIR TABLET;ORAL 600MG No No AB 2022/09/29 2022/09/29 Prescription
002 DARUNAVIR DARUNAVIR TABLET;ORAL 800MG No No AB 2022/09/29 Prescription
003 DARUNAVIR DARUNAVIR TABLET;ORAL 300MG No No None -- None (Tentative Approval)
004 DARUNAVIR DARUNAVIR TABLET;ORAL 400MG No No None -- None (Tentative Approval)
005 DARUNAVIR DARUNAVIR TABLET;ORAL 600MG No No None -- None (Tentative Approval)
006 DARUNAVIR DARUNAVIR TABLET;ORAL 800MG No No None -- None (Tentative Approval)
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
2023/11/19 SUPPL-2(补充) Approval Labeling STANDARD
2023/11/19 SUPPL-1(补充) Approval Labeling STANDARD
2022/09/29 ORIG-1(原始申请) Approval Not Applicable
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:DARUNAVIR 剂型/给药途径:TABLET;ORAL 规格:600MG 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
206288 004 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG None (Tentative Approval) No No AB -- CIPLA
021976 002 NDA PREZISTA DARUNAVIR TABLET;ORAL 600MG Prescription Yes No AB 2008/02/25 JANSSEN PRODS
202118 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2017/11/21 TEVA PHARMS USA
202073 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2022/09/29 LUPIN LTD
202083 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/09/14 HETERO LABS LTD III
206288 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/11/28 CIPLA
210677 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/11/28 AUROBINDO PHARMA LTD
211578 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/11/28 DR REDDYS
215389 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/11/28 MSN
212493 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/12/08 AMNEAL
214085 001 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 600MG Prescription No No AB 2023/12/13 ZYDUS LIFESCIENCES
活性成分:DARUNAVIR 剂型/给药途径:TABLET;ORAL 规格:800MG 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
206288 005 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG None (Tentative Approval) No No AB -- CIPLA
021976 006 NDA PREZISTA DARUNAVIR TABLET;ORAL 800MG Prescription Yes Yes AB 2012/11/09 JANSSEN PRODS
202073 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2022/09/29 LUPIN LTD
206288 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/11/28 CIPLA
215389 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/11/28 MSN
210677 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/11/28 AUROBINDO PHARMA LTD
211578 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/11/28 DR REDDYS
212493 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/12/08 AMNEAL
214085 002 ANDA DARUNAVIR DARUNAVIR TABLET;ORAL 800MG Prescription No No AB 2023/12/13 ZYDUS LIFESCIENCES
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