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 |
|---|
| 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: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
|
MYLAN |
| 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 |