药品注册申请号:213598
申请类型:ANDA (仿制药申请)
申请人:NANJING
申请人全名:NANJING SIMCERE DONGYUAN PHARMACEUTICAL CO 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 CELECOXIB CELECOXIB CAPSULE;ORAL 200MG No No AB 2020/05/13 2020/05/13 Prescription
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
2020/05/13 ORIG-1(原始申请) Approval 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
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:CELECOXIB 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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
020998 002 NDA CELEBREX CELECOXIB CAPSULE;ORAL 200MG Prescription Yes No AB 1998/12/31 UPJOHN
076898 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2014/05/30 TEVA
078857 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Discontinued No No AB 2015/02/11 NORVIUM BIOSCIENCE
200562 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/02/11 WATSON LABS INC
204197 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/06/02 APOTEX
202240 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/06/09 LUPIN LTD
204519 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/08/21 ALEMBIC
207446 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/09/23 CIPLA
207677 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2015/12/23 TORRENT
206827 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2016/02/01 AUROBINDO PHARMA
204590 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2016/03/16 MACLEODS PHARMS LTD
210071 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2018/01/23 CSPC OUYI
204776 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2018/04/30 MICRO LABS
208856 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2019/08/07 QINGDAO BAHEAL PHARM
208701 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2019/11/14 CADILA PHARMS LTD
210628 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2019/11/27 UMEDICA
207872 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2020/02/25 TIANJIN TIANYAO
211412 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2020/03/06 YILING
213598 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2020/05/13 NANJING
205129 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Prescription No No AB 2020/12/03 SCIEGEN PHARMS INC
212564 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 200MG Discontinued No No AB 2023/04/10 YABAO PHARM
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