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 |
|---|
| 2015/03/30 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2005/02/09 |
SUPPL-42（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/02/03 |
SUPPL-39（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/10/19 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/08/14 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/11/03 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/06/24 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/03/24 |
SUPPL-34（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/09/26 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/08/07 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/09/06 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/08/15 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/03/21 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1986/01/13 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1985/05/13 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1984/08/28 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 1983/09/20 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/05/19 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/09/04 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/06/17 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/02/19 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/22 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/16 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1980/11/14 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/01/25 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1979/11/29 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1979/06/21 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/03/09 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/22 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/03/21 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/02/09 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1967/01/10 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
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:ETHACRYNIC ACID 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 |
|---|
| 016092 |
001 |
NDA |
EDECRIN |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
BAUSCH |
| 205609 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/06/30
|
ADAPTIS |
| 207262 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2017/02/23
|
HIKMA |
| 208501 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2017/07/21
|
ENDO OPERATIONS |
| 208805 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/05/08
|
AMNEAL PHARMS CO |
| 205709 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2018/07/24
|
ALVOGEN |
| 211809 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/07/12
|
AGNITIO |
| 211232 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/08/27
|
SCIEGEN PHARMS INC |
| 211719 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2019/09/06
|
LUPIN LTD |
| 212417 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/02/19
|
UPSHER SMITH LABS |
| 213240 |
001 |
ANDA |
ETHACRYNIC ACID |
ETHACRYNIC ACID |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/10/19
|
CHARTWELL RX |
