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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2022/11/23 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2023/08/25 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
UNKNOWN
|
|
|
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:OFLOXACIN; 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC; 规格:0.3%; 治疗等效代码:AT<<<
| 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 |
|---|
| 019921 |
001 |
NDA |
OCUFLOX |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
Yes |
Yes |
AT |
1993/07/30
|
ALLERGAN |
| 076513 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2004/05/14
|
APOTEX INC |
| 076615 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Discontinued |
No |
No |
AT |
2004/05/14
|
EPIC PHARMA LLC |
| 076622 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2004/05/14
|
BAUSCH AND LOMB |
| 076407 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2008/04/15
|
SENTISS |
| 078559 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2009/02/25
|
FDC LTD |
| 202692 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2013/04/29
|
ALTAIRE PHARMS INC |
| 215886 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2022/11/23
|
MANKIND PHARMA |
| 211524 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Discontinued |
No |
No |
AT |
2024/03/01
|
AMNEAL |
| 217904 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2024/04/12
|
CAPLIN |
| 213597 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2024/08/01
|
SOMERSET |