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 |
|---|
| 2008/12/11 |
ORIG-1（原始申请） |
Approval |
|
|
|
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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:CIPROFLOXACIN HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:EQ 0.3% BASE 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 |
|---|
| 019992 |
001 |
NDA |
CILOXAN |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
Yes |
Yes |
AT |
1990/12/31
|
SANDOZ |
| 075928 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
No |
No |
AT |
2004/06/09
|
RUBICON |
| 076754 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Discontinued |
No |
No |
AT |
2004/06/09
|
THE J MOLNER |
| 076673 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
No |
No |
AT |
2005/01/21
|
WATSON LABS INC |
| 077689 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
No |
No |
AT |
2006/12/13
|
RISING |
| 077568 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
No |
No |
AT |
2008/06/30
|
FDC LTD |
| 076555 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Discontinued |
No |
No |
AT |
2008/12/11
|
SCIEGEN PHARMS INC |
| 204613 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.3% BASE |
Prescription |
No |
No |
AT |
2018/05/03
|
ALTAIRE PHARMS INC |