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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2011/10/17 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2025/08/04 |
SUPPL-9（补充） |
Approval |
Labeling-Package Insert |
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:FLUOCINOLONE ACETONIDE; 剂型/给药途径:OIL;TOPICAL; 规格:0.01%; 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 |
|---|
| 019452 |
001 |
NDA |
DERMA-SMOOTHE/FS |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
Yes |
Yes |
AT |
1988/02/03
|
HILL DERMAC |
| 019452 |
002 |
NDA |
DERMA-SMOOTHE/FS |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
Yes |
Yes |
AT |
2005/11/09
|
HILL DERMAC |
| 201759 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Discontinued |
No |
No |
AT |
2011/10/17
|
AMNEAL |
| 201764 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Discontinued |
No |
No |
AT |
2011/10/17
|
AMNEAL |
| 202847 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2013/08/09
|
PADAGIS ISRAEL |
| 202848 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2013/08/09
|
PADAGIS ISRAEL |
| 203377 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2016/04/25
|
RISING |
| 090982 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2016/04/25
|
RISING |
| 202368 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2016/05/19
|
SUN PHARMA CANADA |
| 209336 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2016/05/19
|
SUN PHARMA CANADA |
| 210556 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Discontinued |
No |
No |
AT |
2018/10/25
|
GLENMARK PHARMS LTD |
| 210539 |
001 |
ANDA |
FLUOCINONIDE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Discontinued |
No |
No |
AT |
2018/10/26
|
GLENMARK PHARMS LTD |
| 212760 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2021/04/02
|
QUAGEN |
| 212761 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2021/04/02
|
QUAGEN |
| 207345 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2023/07/31
|
NOVEL LABS INC |
| 207347 |
001 |
ANDA |
FLUOCINOLONE ACETONIDE |
FLUOCINOLONE ACETONIDE |
OIL;TOPICAL |
0.01% |
Prescription |
No |
No |
AT |
2023/08/07
|
NOVEL LABS INC |
