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 |
2024/06/05 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/09/30 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/12/01 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
2005/07/14 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1996/08/28 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/11/22 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1995/05/31 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/14 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1994/02/08 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1992/01/09 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1992/01/06 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1991/12/06 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/12/06 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/12/06 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/01/24 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1988/05/11 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/11 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/05/23 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/04/17 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/11/29 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/09/15 |
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:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:1MG 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 |
088306 |
001 |
ANDA |
DEXAMETHASONE |
DEXAMETHASONE |
TABLET;ORAL |
1MG |
Prescription |
Yes |
Yes |
AB |
1983/09/15
|
HIKMA |
217695 |
003 |
ANDA |
DEXAMETHASONE |
DEXAMETHASONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2023/08/23
|
APOTEX |
216284 |
001 |
ANDA |
DEXAMETHASONE |
DEXAMETHASONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2024/05/09
|
ZYDUS LIFESCIENCES |
218372 |
003 |
ANDA |
DEXAMETHASONE |
DEXAMETHASONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2024/09/17
|
COREPHARMA |