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 |
|---|
| 2023/02/01 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/05/31 |
SUPPL-28（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2010/04/28 |
SUPPL-27（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2009/11/13 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/04/13 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/08/13 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/08/30 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/09/22 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/10/03 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/09/06 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/09/06 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/07/23 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/07/23 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/06/09 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/02/19 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/11/24 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/08/17 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/12/13 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/04/18 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1988/12/07 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1988/10/27 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/07/21 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/05/11 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1988/05/11 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1987/10/14 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/09/18 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/18 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1984/10/10 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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 剂型/给药途径:SYSTEM;TRANSDERMAL 规格:0.1MG/24HR 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 |
|---|
| 018891 |
001 |
NDA |
CATAPRES-TTS-1 |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.1MG/24HR |
Prescription |
Yes |
No |
AB |
1984/10/10
|
LAVIPHARM |
| 076157 |
001 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.1MG/24HR |
Prescription |
No |
No |
AB |
2009/08/18
|
DIFGEN PHARMS |
| 076166 |
001 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.1MG/24HR |
Prescription |
No |
No |
AB |
2010/07/16
|
MYLAN TECHNOLOGIES |
| 079090 |
001 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.1MG/24HR |
Prescription |
No |
No |
AB |
2010/08/20
|
DR REDDYS LABS SA |
| 090873 |
001 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.1MG/24HR |
Prescription |
No |
No |
AB |
2014/05/06
|
ACTAVIS LABS UT INC |
活性成分:CLONIDINE 剂型/给药途径:SYSTEM;TRANSDERMAL 规格:0.2MG/24HR 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 |
|---|
| 018891 |
002 |
NDA |
CATAPRES-TTS-2 |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.2MG/24HR |
Prescription |
Yes |
No |
AB |
1984/10/10
|
LAVIPHARM |
| 076157 |
002 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.2MG/24HR |
Prescription |
No |
No |
AB |
2009/08/18
|
DIFGEN PHARMS |
| 076166 |
002 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.2MG/24HR |
Prescription |
No |
No |
AB |
2010/07/16
|
MYLAN TECHNOLOGIES |
| 079090 |
002 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.2MG/24HR |
Prescription |
No |
No |
AB |
2010/08/20
|
DR REDDYS LABS SA |
| 090873 |
002 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.2MG/24HR |
Prescription |
No |
No |
AB |
2014/05/06
|
ACTAVIS LABS UT INC |
活性成分:CLONIDINE 剂型/给药途径:SYSTEM;TRANSDERMAL 规格:0.3MG/24HR 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 |
|---|
| 018891 |
003 |
NDA |
CATAPRES-TTS-3 |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.3MG/24HR |
Prescription |
Yes |
Yes |
AB |
1984/10/10
|
LAVIPHARM |
| 076157 |
003 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.3MG/24HR |
Prescription |
No |
No |
AB |
2009/08/18
|
DIFGEN PHARMS |
| 076166 |
003 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.3MG/24HR |
Prescription |
No |
No |
AB |
2010/07/16
|
MYLAN TECHNOLOGIES |
| 079090 |
003 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.3MG/24HR |
Prescription |
No |
No |
AB |
2010/08/20
|
DR REDDYS LABS SA |
| 090873 |
003 |
ANDA |
CLONIDINE |
CLONIDINE |
SYSTEM;TRANSDERMAL |
0.3MG/24HR |
Prescription |
No |
No |
AB |
2014/05/06
|
ACTAVIS LABS UT INC |
