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 |
|---|
| 2016/01/08 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 1998/09/08 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/12/31 |
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:FLUOCINONIDE 剂型/给药途径:SOLUTION;TOPICAL 规格:0.05% 治疗等效代码:AT
| 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 |
|---|
| 018849 |
001 |
NDA |
LIDEX |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
Yes |
No |
AT |
1984/04/06
|
ALVOGEN |
| 071535 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
1988/12/02
|
COSETTE |
| 072934 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
1995/02/27
|
FOUGERA PHARMS INC |
| 074799 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
Yes |
AT |
1996/12/31
|
TARO |
| 206003 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2017/07/21
|
NOVEL LABS INC |
| 209118 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2018/04/23
|
CHARTWELL RX |
| 209283 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2018/04/23
|
MACLEODS PHARMS LTD |
| 208948 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2018/07/17
|
ZYDUS PHARMS |
| 209699 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2018/11/29
|
ENCUBE ETHICALS |
| 207554 |
001 |
ANDA |
FLUOCINONIDE |
FLUOCINONIDE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
2019/03/18
|
PAI HOLDINGS PHARM |