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 |
|---|
| 2024/09/20 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/12/30 |
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:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 250MG/50ML (EQ 5MG/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 |
|---|
| 090343 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
Yes |
AP |
2011/07/07
|
INFORLIFE |
| 091375 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2011/09/16
|
HIKMA FARMACEUTICA |
| 200674 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/06/19
|
FRESENIUS KABI USA |
| 091397 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/08/08
|
BAXTER HLTHCARE CORP |
| 078579 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2015/09/03
|
HOSPIRA |
| 206919 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2016/02/10
|
EUGIA PHARMA |
| 206908 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2020/12/30
|
GLAND PHARMA LTD |
| 216164 |
001 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 250MG/50ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2024/01/29
|
KNACK |
活性成分:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG/100ML (EQ 5MG/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 |
|---|
| 090343 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
Yes |
AP |
2011/07/07
|
INFORLIFE |
| 091375 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2011/09/16
|
HIKMA FARMACEUTICA |
| 200674 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/06/19
|
FRESENIUS KABI USA |
| 091397 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/08/08
|
BAXTER HLTHCARE CORP |
| 078579 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2015/09/03
|
HOSPIRA |
| 206919 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2016/02/10
|
EUGIA PHARMA |
| 206908 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2020/12/30
|
GLAND PHARMA LTD |
| 216164 |
002 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 500MG/100ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2024/01/29
|
KNACK |
活性成分:LEVOFLOXACIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 750MG/150ML (EQ 5MG/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 |
|---|
| 090343 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
Yes |
AP |
2011/07/07
|
INFORLIFE |
| 091375 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2011/09/16
|
HIKMA FARMACEUTICA |
| 200674 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/06/19
|
FRESENIUS KABI USA |
| 091397 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2013/08/08
|
BAXTER HLTHCARE CORP |
| 078579 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2015/09/03
|
HOSPIRA |
| 206919 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2016/02/10
|
EUGIA PHARMA |
| 206908 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Prescription |
No |
No |
AP |
2020/12/30
|
GLAND PHARMA LTD |
| 216164 |
003 |
ANDA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
LEVOFLOXACIN |
INJECTABLE;INJECTION |
EQ 750MG/150ML (EQ 5MG/ML) |
Discontinued |
No |
No |
AP |
2024/01/29
|
KNACK |