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 |
2022/01/05 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/10/09 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/10/09 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2019/10/09 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/09/16 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/09 |
ORIG-2(原始申请) |
Approval |
|
|
|
|
2014/10/29 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 | RLD | RS | TE 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 |
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 | RLD | RS | TE 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 |