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 |
|---|
| 2018/06/22 |
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:CIPROFLOXACIN HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 250MG BASE 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 |
|---|
| 019537 |
002 |
NDA |
CIPRO |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
Yes |
No |
AB |
1987/10/22
|
BAYER HLTHCARE |
| 075593 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
DR REDDYS LABS LTD |
| 075939 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
AMNEAL |
| 076089 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
IVAX SUB TEVA PHARMS |
| 076126 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
CARLSBAD |
| 076558 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
HIKMA |
| 076593 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
AIPING PHARM INC |
| 076794 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
WATSON LABS |
| 076639 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/09/10
|
UNIQUE |
| 076896 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2004/11/04
|
CHARTWELL |
| 077859 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2007/04/26
|
AUROBINDO PHARMA |
| 208921 |
001 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 250MG BASE |
Prescription |
No |
No |
AB |
2018/06/22
|
YILING |
活性成分:CIPROFLOXACIN HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 500MG BASE 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 |
|---|
| 019537 |
003 |
NDA |
CIPRO |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
Yes |
Yes |
AB |
1987/10/22
|
BAYER HLTHCARE |
| 075593 |
004 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
DR REDDYS LABS LTD |
| 075817 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
RISING |
| 075939 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
AMNEAL |
| 076089 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
IVAX SUB TEVA PHARMS |
| 076126 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
CARLSBAD |
| 076558 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
HIKMA |
| 076593 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
AIPING PHARM INC |
| 076794 |
003 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/06/09
|
WATSON LABS |
| 076639 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/09/10
|
UNIQUE |
| 076896 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2004/11/04
|
CHARTWELL |
| 077859 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2007/04/26
|
AUROBINDO PHARMA |
| 208921 |
002 |
ANDA |
CIPROFLOXACIN HYDROCHLORIDE |
CIPROFLOXACIN HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2018/06/22
|
YILING |