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 |
|---|
| 2020/05/29 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/11/20 |
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:CLONIDINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:0.1MG 治疗等效代码:AB1
| 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 |
|---|
| 022331 |
003 |
NDA |
KAPVAY |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Discontinued |
Yes |
No |
AB1 |
2010/09/28
|
CONCORDIA PHARMS INC |
| 202984 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Discontinued |
No |
No |
AB1 |
2013/09/30
|
ENDO OPERATIONS |
| 203320 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
No |
AB1 |
2015/05/15
|
ACTAVIS ELIZABETH |
| 209285 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
No |
AB1 |
2017/10/23
|
CHARTWELL RX |
| 209686 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
Yes |
AB1 |
2017/11/20
|
AJANTA PHARMA LTD |
| 209757 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
No |
AB1 |
2017/11/20
|
XIAMEN LP PHARM CO |
| 210052 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Discontinued |
No |
No |
AB1 |
2017/11/20
|
AMNEAL PHARMS NY |
| 210338 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
No |
AB1 |
2018/01/29
|
JUBILANT GENERICS |
| 209675 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
0.1MG |
Prescription |
No |
No |
AB1 |
2019/03/05
|
NOVAST LABS |