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 |
|---|
| 2020/05/19 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/07/21 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/13 |
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:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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 |
|---|
| 074477 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
1996/02/13
|
PRINSTON INC |
| 074505 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
1996/02/13
|
HIKMA INTL PHARMS |
| 074532 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
1997/03/28
|
WOCKHARDT |
| 074677 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
1997/05/30
|
ANDAS 5 HOLDING |
| 074737 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
1998/10/28
|
COREPHARMA |
| 212809 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2019/12/13
|
AJANTA PHARMA LTD |
| 214442 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2023/01/27
|
CHANGZHOU PHARM |
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格: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 |
|---|
| 074477 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1996/02/13
|
PRINSTON INC |
| 074505 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1996/02/13
|
HIKMA INTL PHARMS |
| 074532 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1997/03/28
|
WOCKHARDT |
| 074677 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1997/05/30
|
ANDAS 5 HOLDING |
| 074737 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1998/10/28
|
COREPHARMA |
| 212809 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/12/13
|
AJANTA PHARMA LTD |
| 214442 |
002 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2023/01/27
|
CHANGZHOU PHARM |
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
|---|
| 074477 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1996/02/13
|
PRINSTON INC |
| 074505 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1996/02/13
|
HIKMA INTL PHARMS |
| 074532 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1997/03/28
|
WOCKHARDT |
| 074677 |
001 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1997/05/30
|
ANDAS 5 HOLDING |
| 074737 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1998/10/28
|
COREPHARMA |
| 212809 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/12/13
|
AJANTA PHARMA LTD |
| 214442 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/01/27
|
CHANGZHOU PHARM |
活性成分:CAPTOPRIL 剂型/给药途径:TABLET;ORAL 规格:100MG 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 |
|---|
| 074477 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1996/02/13
|
PRINSTON INC |
| 074505 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
Yes |
AB |
1996/02/13
|
HIKMA INTL PHARMS |
| 074532 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1997/03/28
|
WOCKHARDT |
| 074677 |
003 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1997/05/30
|
ANDAS 5 HOLDING |
| 074737 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1998/10/28
|
COREPHARMA |
| 212809 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2019/12/13
|
AJANTA PHARMA LTD |
| 214442 |
004 |
ANDA |
CAPTOPRIL |
CAPTOPRIL |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/01/27
|
CHANGZHOU PHARM |