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 |
|---|
| 2013/01/17 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/09/23 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2010/03/15 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2009/08/26 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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;ORAL 规格:0.1MG 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 |
|---|
| 070974 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
1986/12/16
|
ACTAVIS ELIZABETH |
| 070923 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
1987/09/04
|
TRUPHARMA |
| 071785 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
1988/04/05
|
CHARTWELL MOLECULES |
| 070886 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
1988/08/31
|
AUROBINDO PHARMA LTD |
| 077901 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
2007/03/09
|
PRINSTON INC |
| 078895 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
2009/08/26
|
UNICHEM |
| 078099 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
2009/08/27
|
IMPAX LABS |
| 091368 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
2011/12/06
|
ALEMBIC PHARMS LTD |
| 202297 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.1MG |
Prescription |
No |
No |
AB |
2013/06/13
|
YUNG SHIN PHARM |
活性成分:CLONIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:0.2MG 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 |
|---|
| 070975 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
1986/12/16
|
ACTAVIS ELIZABETH |
| 070923 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
1987/09/04
|
TRUPHARMA |
| 071785 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
1988/04/05
|
CHARTWELL MOLECULES |
| 070886 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
1988/08/31
|
AUROBINDO PHARMA LTD |
| 077901 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
2007/03/09
|
PRINSTON INC |
| 078895 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
2009/08/26
|
UNICHEM |
| 078099 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
2009/08/27
|
IMPAX LABS |
| 091368 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
2011/12/06
|
ALEMBIC PHARMS LTD |
| 202297 |
002 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.2MG |
Prescription |
No |
No |
AB |
2013/06/13
|
YUNG SHIN PHARM |
活性成分:CLONIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:0.3MG 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 |
|---|
| 070976 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
1986/12/16
|
ACTAVIS ELIZABETH |
| 070923 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
1987/09/04
|
TRUPHARMA |
| 071785 |
001 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
1988/04/05
|
CHARTWELL MOLECULES |
| 070886 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
1988/08/31
|
AUROBINDO PHARMA LTD |
| 077901 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
2007/03/09
|
PRINSTON INC |
| 078895 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
Yes |
AB |
2009/08/26
|
UNICHEM |
| 078099 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
2009/08/27
|
IMPAX LABS |
| 091368 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
2011/12/06
|
ALEMBIC PHARMS LTD |
| 202297 |
003 |
ANDA |
CLONIDINE HYDROCHLORIDE |
CLONIDINE HYDROCHLORIDE |
TABLET;ORAL |
0.3MG |
Prescription |
No |
No |
AB |
2013/06/13
|
YUNG SHIN PHARM |