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 |
|---|
| 2014/02/20 |
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:CLONIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/10ML (0.1MG/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 |
|---|
| 020615 |
001 |
NDA |
DURACLON |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
Yes |
No |
AP |
1996/10/02
|
MYLAN INSTITUTIONAL |
| 200300 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2011/01/26
|
HIKMA FARMACEUTICA |
| 200673 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2011/07/08
|
FRESENIUS KABI USA |
| 203167 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2013/10/29
|
XGEN PHARMS |
| 202601 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2014/02/20
|
ZYDUS PHARMS |
活性成分:CLONIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5MG/10ML (0.5MG/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 |
|---|
| 200300 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
5MG/10ML (0.5MG/ML) |
Prescription |
No |
Yes |
AP |
2011/01/26
|
HIKMA FARMACEUTICA |
| 200673 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
5MG/10ML (0.5MG/ML) |
Prescription |
No |
No |
AP |
2011/07/08
|
FRESENIUS KABI USA |
| 203167 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
5MG/10ML (0.5MG/ML) |
Prescription |
No |
No |
AP |
2013/10/29
|
XGEN PHARMS |
| 202601 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
5MG/10ML (0.5MG/ML) |
Prescription |
No |
No |
AP |
2014/02/20
|
ZYDUS PHARMS |