药品注册申请号：210628
申请类型：ANDA (仿制药申请)
申请人：UMEDICA
申请人全名：UMEDICA LABORATORIES PRIVATE 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 50MG No No AB 2019/11/27 2019/11/27 Prescription
002 CELECOXIB CELECOXIB CAPSULE;ORAL 100MG No No AB 2019/11/27 Prescription
003 CELECOXIB CELECOXIB CAPSULE;ORAL 200MG No No AB 2019/11/27 Prescription
004 CELECOXIB CELECOXIB CAPSULE;ORAL 400MG No No AB 2019/11/27 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
2022/01/11 SUPPL-2（补充） Approval Labeling STANDARD
2019/11/27 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
无
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
无
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:50MG 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 004 NDA CELEBREX CELECOXIB CAPSULE;ORAL 50MG Prescription Yes No AB 2006/12/15 UPJOHN
076898 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2014/05/30 TEVA
078857 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Discontinued No No AB 2014/05/30 NORVIUM BIOSCIENCE
202240 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2014/10/29 LUPIN LTD
200562 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2015/02/11 WATSON LABS INC
204197 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2015/06/02 APOTEX
204519 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2015/08/21 ALEMBIC
207446 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2015/09/23 CIPLA
207677 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2015/12/23 TORRENT
206827 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2016/02/01 AUROBINDO PHARMA
204590 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2016/03/16 MACLEODS PHARMS LTD
210071 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2018/01/23 CSPC OUYI
204776 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2018/04/30 MICRO LABS
208856 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2019/08/07 QINGDAO BAHEAL PHARM
208701 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2019/11/14 CADILA PHARMS LTD
210628 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2019/11/27 UMEDICA
207872 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2020/02/25 TIANJIN TIANYAO
211412 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2020/03/06 YILING
205129 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 50MG Prescription No No AB 2020/12/03 SCIEGEN PHARMS INC
活性成分:CELECOXIB 剂型/给药途径:CAPSULE;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
020998 001 NDA CELEBREX CELECOXIB CAPSULE;ORAL 100MG Prescription Yes No AB 1998/12/31 UPJOHN
076898 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2014/05/30 TEVA
078857 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Discontinued No No AB 2015/02/11 NORVIUM BIOSCIENCE
200562 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/02/11 WATSON LABS INC
204197 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/06/02 APOTEX
202240 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/06/09 LUPIN LTD
204519 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/08/21 ALEMBIC
207446 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/09/23 CIPLA
207677 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2015/12/23 TORRENT
206827 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2016/02/01 AUROBINDO PHARMA
204590 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2016/03/16 MACLEODS PHARMS LTD
210071 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2018/01/23 CSPC OUYI
204776 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2018/04/30 MICRO LABS
208856 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2019/08/07 QINGDAO BAHEAL PHARM
208701 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2019/11/14 CADILA PHARMS LTD
210628 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2019/11/27 UMEDICA
207872 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2020/02/25 TIANJIN TIANYAO
211412 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2020/03/06 YILING
205129 002 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Prescription No No AB 2020/12/03 SCIEGEN PHARMS INC
212564 001 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 100MG Discontinued No No AB 2023/04/10 YABAO PHARM
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
活性成分:CELECOXIB 剂型/给药途径:CAPSULE;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
020998 003 NDA CELEBREX CELECOXIB CAPSULE;ORAL 400MG Prescription Yes Yes AB 2002/08/29 UPJOHN
076898 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2014/05/30 TEVA
078857 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Discontinued No No AB 2015/02/11 NORVIUM BIOSCIENCE
200562 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2015/02/11 WATSON LABS INC
202240 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2015/06/09 LUPIN LTD
204519 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2015/08/21 ALEMBIC
207446 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2015/09/23 CIPLA
207677 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2015/12/23 TORRENT
206827 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2016/02/01 AUROBINDO PHARMA
204590 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2016/03/16 MACLEODS PHARMS LTD
204776 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2018/04/30 MICRO LABS
208856 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2019/08/07 QINGDAO BAHEAL PHARM
208701 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2019/11/14 CADILA PHARMS LTD
210628 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2019/11/27 UMEDICA
207872 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2020/02/25 TIANJIN TIANYAO
211412 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2020/03/06 YILING
205129 004 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Prescription No No AB 2020/12/03 SCIEGEN PHARMS INC
212564 003 ANDA CELECOXIB CELECOXIB CAPSULE;ORAL 400MG Discontinued No No AB 2023/04/10 YABAO PHARM
更多信息
药品NDC数据与药品包装、标签说明书
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