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 |
|---|
| 2004/03/11 |
SUPPL-12（补充） |
Approval |
Labeling |
|
|
|
| 2002/01/23 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/31 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/31 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/18 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/18 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/18 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/05/15 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/03/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/12/15 |
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:CLOBETASOL PROPIONATE 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 |
|---|
| 074222 |
001 |
ANDA |
EMBELINE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
1995/12/06
|
HIKMA |
| 074331 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
1995/12/15
|
COSETTE |
| 075205 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
1998/11/13
|
WOCKHARDT BIO AG |
| 075224 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
Yes |
AT |
1998/11/16
|
TARO |
| 075391 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
1999/02/08
|
FOUGERA PHARMS |
| 075363 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2000/12/29
|
TARO |
| 076977 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2005/08/05
|
ENCUBE |
| 206075 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2015/11/23
|
NOVEL LABS INC |
| 209361 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2017/10/25
|
MACLEODS PHARMS LTD |
| 210190 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2018/04/18
|
GLENMARK PHARMS LTD |
| 211494 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2019/10/02
|
SAPTALIS PHARMS |
| 212881 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2019/10/21
|
ALEMBIC |
| 213139 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Discontinued |
No |
No |
AT |
2021/02/08
|
PRINSTON INC |
| 211240 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
SOLUTION;TOPICAL |
0.05% |
Prescription |
No |
No |
AT |
2022/02/17
|
QUAGEN |