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 |
|---|
| 2024/02/12 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/31 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/31 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/31 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/31 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/06/27 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/06/27 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/06 |
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:LINEZOLID 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:200MG/100ML (2MG/ML) 治疗等效代码:AP
| 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 |
|---|
| 021131 |
001 |
NDA |
ZYVOX |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
Yes |
No |
AP |
2000/04/18
|
PFIZER |
| 200904 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2015/07/16
|
SANDOZ |
| 207354 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2016/12/20
|
NANG KUANG PHARM CO |
| 204696 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/03/02
|
SAGENT PHARMS INC |
| 207001 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/07/07
|
HQ SPCLT PHARMA |
| 205154 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
MYLAN LABS LTD |
活性成分:LINEZOLID 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:600MG/300ML (2MG/ML) 治疗等效代码:AP
| 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 |
|---|
| 021131 |
003 |
NDA |
ZYVOX |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
Yes |
Yes |
AP |
2000/04/18
|
PFIZER |
| 200222 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Discontinued |
No |
No |
AP |
2012/06/27
|
TEVA PHARMS |
| 200904 |
002 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2015/07/16
|
SANDOZ |
| 204764 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
| 206917 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2016/08/04
|
EUGIA PHARMA |
| 207354 |
002 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2016/12/20
|
NANG KUANG PHARM CO |
| 204696 |
002 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/03/02
|
SAGENT PHARMS INC |
| 207001 |
002 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/07/07
|
HQ SPCLT PHARMA |
| 205154 |
002 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
MYLAN LABS LTD |
| 206454 |
001 |
ANDA |
LINEZOLID |
LINEZOLID |
SOLUTION;INTRAVENOUS |
600MG/300ML (2MG/ML) |
Prescription |
No |
No |
AP |
2022/08/22
|
HIKMA |
