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 |
|---|
| 2020/05/21 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/04 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/04 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/11/30 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/11/10 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2012/10/05 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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, EXTENDED RELEASE;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 |
|---|
| 022037 |
001 |
NDA |
INTUNIV |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
Yes |
No |
AB |
2009/09/02
|
TAKEDA PHARMS USA |
| 200881 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2012/10/05
|
ACTAVIS ELIZABETH |
| 201382 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TEVA PHARMS USA |
| 201408 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TWI PHARMS |
| 202568 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2015/06/03
|
SANDOZ |
| 205689 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2017/11/16
|
SUN PHARM |
| 205430 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2018/07/25
|
APOTEX |
| 213428 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2020/11/25
|
YICHANG HUMANWELL |
| 217269 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/08/07
|
ALEMBIC |
| 217638 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/06/12
|
WANBANG BIOPHARMS |
| 219033 |
001 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/11/19
|
UNICHEM |
活性成分:GUANFACINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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 |
|---|
| 022037 |
002 |
NDA |
INTUNIV |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
Yes |
No |
AB |
2009/09/02
|
TAKEDA PHARMS USA |
| 200881 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2012/10/05
|
ACTAVIS ELIZABETH |
| 201382 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TEVA PHARMS USA |
| 201408 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TWI PHARMS |
| 202568 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2015/06/03
|
SANDOZ |
| 205689 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2017/11/16
|
SUN PHARM |
| 205430 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/07/25
|
APOTEX |
| 213428 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2020/11/25
|
YICHANG HUMANWELL |
| 217269 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2023/08/07
|
ALEMBIC |
| 217638 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/06/12
|
WANBANG BIOPHARMS |
| 219033 |
002 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/11/19
|
UNICHEM |
活性成分:GUANFACINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 3MG 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 |
|---|
| 022037 |
003 |
NDA |
INTUNIV |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
Yes |
No |
AB |
2009/09/02
|
TAKEDA PHARMS USA |
| 200881 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2012/10/05
|
ACTAVIS ELIZABETH |
| 201382 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TEVA PHARMS USA |
| 201408 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TWI PHARMS |
| 202568 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2015/06/03
|
SANDOZ |
| 205689 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2017/11/16
|
SUN PHARM |
| 205430 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2018/07/25
|
APOTEX |
| 213428 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2020/11/25
|
YICHANG HUMANWELL |
| 217269 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2023/08/07
|
ALEMBIC |
| 217638 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2024/06/12
|
WANBANG BIOPHARMS |
| 219033 |
003 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 3MG BASE |
Prescription |
No |
No |
AB |
2024/11/19
|
UNICHEM |
活性成分:GUANFACINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 4MG 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 |
|---|
| 022037 |
004 |
NDA |
INTUNIV |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
Yes |
Yes |
AB |
2009/09/02
|
TAKEDA PHARMS USA |
| 200881 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/10/05
|
ACTAVIS ELIZABETH |
| 201382 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TEVA PHARMS USA |
| 201408 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2015/06/02
|
TWI PHARMS |
| 202568 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2015/06/03
|
SANDOZ |
| 205689 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2017/11/16
|
SUN PHARM |
| 205430 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2018/07/25
|
APOTEX |
| 213428 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2020/11/25
|
YICHANG HUMANWELL |
| 217269 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2023/08/07
|
ALEMBIC |
| 217638 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2024/06/12
|
WANBANG BIOPHARMS |
| 219033 |
004 |
ANDA |
GUANFACINE HYDROCHLORIDE |
GUANFACINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2024/11/19
|
UNICHEM |
