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
|
EDENBRIDGE PHARMS |
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 |