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 |
|---|
| 2019/12/23 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/12/23 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/30 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/30 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/30 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/10/21 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2011/09/14 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1993/06/15 |
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:PIROXICAM 剂型/给药途径:CAPSULE;ORAL 规格:20MG 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 |
|---|
| 018147 |
003 |
NDA |
FELDENE |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
Yes |
Yes |
AB |
1982/04/06
|
PFIZER |
| 074131 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
1992/12/11
|
TEVA |
| 074118 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
1993/06/15
|
NOSTRUM LABS INC |
| 207938 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2016/09/09
|
FLAMINGO PHARMS |
| 208340 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/04/13
|
UNICHEM |
| 206136 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/06/20
|
STRIDES PHARMA |
| 209256 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2017/08/11
|
HIKMA |
| 206152 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/12/29
|
MICRO LABS |
| 210347 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/01/26
|
STRIDES PHARMA |
| 205585 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/07/17
|
ZYDUS LIFESCIENCES |
活性成分:PIROXICAM 剂型/给药途径:CAPSULE;ORAL 规格:10MG 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 |
|---|
| 018147 |
002 |
NDA |
FELDENE |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
Yes |
No |
AB |
1982/04/06
|
PFIZER |
| 074131 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
1992/12/11
|
TEVA |
| 074118 |
002 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
1993/06/15
|
NOSTRUM LABS INC |
| 207938 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2016/09/09
|
FLAMINGO PHARMS |
| 208340 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/04/13
|
UNICHEM |
| 206136 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/06/20
|
STRIDES PHARMA |
| 209256 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2017/08/11
|
HIKMA |
| 206152 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/12/29
|
MICRO LABS |
| 210347 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/01/26
|
STRIDES PHARMA |
| 205585 |
001 |
ANDA |
PIROXICAM |
PIROXICAM |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/07/17
|
ZYDUS LIFESCIENCES |