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 |
|---|
| 2024/11/21 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/12/28 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/22 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2016/12/06 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2007/10/25 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2006/07/19 |
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:MELOXICAM 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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 |
|---|
| 020938 |
001 |
NDA |
MOBIC |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Discontinued |
Yes |
No |
AB |
2000/04/13
|
BOEHRINGER INGELHEIM |
| 077929 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
CIPLA |
| 077920 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
AIPING PHARM INC |
| 077921 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
ZYDUS PHARMS USA |
| 077932 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
GLENMARK PHARMS LTD |
| 077938 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
PURACAP PHARM |
| 077944 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/19
|
LUPIN PHARMS |
| 077882 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/20
|
COREPHARMA |
| 077931 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/07/25
|
DR REDDYS LABS INC |
| 078008 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/10/02
|
AUROBINDO PHARMA |
| 078102 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/11/07
|
TARO |
| 077918 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/12/07
|
YUNG SHIN PHARM |
| 077927 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/12/20
|
UNICHEM |
| 077928 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2009/05/13
|
ESJAY PHARMA |
| 217579 |
001 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2023/06/07
|
ASCENT PHARMS INC |
活性成分:MELOXICAM 剂型/给药途径:TABLET;ORAL 规格:15MG 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 |
|---|
| 020938 |
002 |
NDA |
MOBIC |
MELOXICAM |
TABLET;ORAL |
15MG |
Discontinued |
Yes |
No |
AB |
2000/08/23
|
BOEHRINGER INGELHEIM |
| 077929 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/19
|
CIPLA |
| 077920 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/19
|
AIPING PHARM INC |
| 077921 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
Yes |
AB |
2006/07/19
|
ZYDUS PHARMS USA |
| 077932 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/19
|
GLENMARK PHARMS LTD |
| 077938 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/19
|
PURACAP PHARM |
| 077944 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/19
|
LUPIN PHARMS |
| 077882 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/20
|
COREPHARMA |
| 077931 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/07/25
|
DR REDDYS LABS INC |
| 078008 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/10/02
|
AUROBINDO PHARMA |
| 078102 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/11/07
|
TARO |
| 077918 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/12/07
|
YUNG SHIN PHARM |
| 077927 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2006/12/20
|
UNICHEM |
| 077928 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/05/13
|
ESJAY PHARMA |
| 217579 |
002 |
ANDA |
MELOXICAM |
MELOXICAM |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2023/06/07
|
ASCENT PHARMS INC |
