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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1995/10/17 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2016/11/30 |
SUPPL-21（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2003/07/16 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/05 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2002/05/21 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2001/09/27 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
|
|
|
| 2001/09/05 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1999/11/10 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1998/03/18 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 1MG 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 |
|---|
| 074145 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1995/10/17
|
WATSON LABS |
| 074796 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1997/01/27
|
AUROBINDO PHARMA USA |
| 074673 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1997/02/28
|
EPIC PHARMA LLC |
| 075109 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1998/11/25
|
AMNEAL PHARM |
| 214689 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2021/03/03
|
UNICHEM |
| 216399 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2022/06/08
|
AIPING PHARM INC |
| 217293 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/04/27
|
AJANTA PHARMA LTD |
| 216828 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/10/05
|
I 3 PHARMS |
| 218326 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/02/23
|
XIROMED |
>>>活性成分:GUANFACINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 2MG 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 |
|---|
| 074145 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1995/10/17
|
WATSON LABS |
| 074796 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1997/01/27
|
AUROBINDO PHARMA USA |
| 074673 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1997/02/28
|
EPIC PHARMA LLC |
| 075109 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
Yes |
AB |
1998/11/25
|
AMNEAL PHARM |
| 214689 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2021/03/03
|
UNICHEM |
| 216399 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/06/08
|
AIPING PHARM INC |
| 217293 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2023/04/27
|
AJANTA PHARMA LTD |
| 216828 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2023/10/05
|
I 3 PHARMS |
| 218326 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/02/23
|
XIROMED |