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 |
|---|
| 2023/12/22 |
SUPPL-42（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/02 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/20 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/07/27 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/12 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/12/12 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/05/03 |
SUPPL-28（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2011/05/03 |
SUPPL-27（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2009/11/06 |
SUPPL-26（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2007/09/25 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/01/24 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/04/04 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/06/22 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/02/16 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/04/01 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/01/15 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/10/09 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/04/24 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/05/30 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/04/15 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/11/24 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/09/07 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/03/26 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
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:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:5MG;6.25MG 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 |
|---|
| 020186 |
001 |
NDA |
ZIAC |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
Yes |
No |
AB |
1993/03/26
|
TEVA BRANDED PHARM |
| 075579 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
EPIC PHARMA LLC |
| 075768 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
MYLAN |
| 079106 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2010/07/28
|
UNICHEM |
| 212678 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2020/07/09
|
EDENBRIDGE PHARMS |
| 215562 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2021/11/04
|
NOVITIUM PHARMA |
| 215995 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2022/01/26
|
GLENMARK PHARMS LTD |
| 215666 |
002 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
5MG;6.25MG |
Prescription |
No |
No |
AB |
2022/11/04
|
CADILA |
活性成分:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:10MG;6.25MG 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 |
|---|
| 020186 |
002 |
NDA |
ZIAC |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
Yes |
Yes |
AB |
1993/03/26
|
TEVA BRANDED PHARM |
| 075579 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
EPIC PHARMA LLC |
| 075768 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
MYLAN |
| 079106 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2010/07/28
|
UNICHEM |
| 212678 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2020/07/09
|
EDENBRIDGE PHARMS |
| 215562 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2021/11/04
|
NOVITIUM PHARMA |
| 215995 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2022/01/26
|
GLENMARK PHARMS LTD |
| 215666 |
003 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
10MG;6.25MG |
Prescription |
No |
No |
AB |
2022/11/04
|
CADILA |
活性成分:BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:2.5MG;6.25MG 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 |
|---|
| 020186 |
003 |
NDA |
ZIAC |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
Yes |
No |
AB |
1993/03/26
|
TEVA BRANDED PHARM |
| 075579 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
EPIC PHARMA LLC |
| 075768 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2000/09/25
|
MYLAN |
| 079106 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2010/07/28
|
UNICHEM |
| 212678 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2020/07/09
|
EDENBRIDGE PHARMS |
| 215562 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2021/11/04
|
NOVITIUM PHARMA |
| 215995 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2022/01/26
|
GLENMARK PHARMS LTD |
| 215666 |
001 |
ANDA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
2.5MG;6.25MG |
Prescription |
No |
No |
AB |
2022/11/04
|
CADILA |
