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 |
2018/05/21 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/28 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2005/09/09 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/07/17 |
SUPPL-15(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/07/17 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/07/13 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/07 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/05/14 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/12/28 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/02 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/05 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/04/16 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/01/25 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/03/11 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/09/25 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/06/13 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/03/30 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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 |
001 |
4775529 |
2007/05/21 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
4775529*PED |
2007/11/21 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
与本品治疗等效的药品
活性成分:MOMETASONE FUROATE 剂型/给药途径:LOTION;TOPICAL 规格:0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB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 |
019796 |
001 |
NDA |
ELOCON |
MOMETASONE FUROATE |
LOTION;TOPICAL |
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
1989/03/30
|
ORGANON |