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 |
|---|
| 2019/09/06 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/11/07 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 2002/12/23 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/12/09 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/12/09 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/11/07 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/07/11 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/04/06 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/11 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/25 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1997/11/25 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/25 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/25 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/08/19 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/07/08 |
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:CREAM;TOPICAL 规格:0.05% 治疗等效代码:AB1
| 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 |
|---|
| 074139 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Discontinued |
No |
No |
AB1 |
1994/08/03
|
COSETTE |
| 074249 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
1996/07/08
|
TARO |
| 074392 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
1996/09/30
|
FOUGERA PHARMS INC |
| 074220 |
001 |
ANDA |
CORMAX |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Discontinued |
No |
No |
AB1 |
1997/05/16
|
HIKMA |
| 075338 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2001/02/09
|
AUROBINDO PHARMA USA |
| 210208 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2018/01/30
|
LUPIN LTD |
| 209974 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Discontinued |
No |
No |
AB1 |
2018/04/17
|
PAI HOLDINGS PHARM |
| 209095 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2018/05/10
|
GLENMARK SPECLT |
| 210034 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2018/06/15
|
XIROMED |
| 211074 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2018/10/15
|
ZYDUS PHARMS |
| 211256 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2018/12/26
|
AMNEAL |
| 211401 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2019/01/11
|
RISING |
| 211836 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2019/12/30
|
TORRENT |
| 213291 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
No |
AB1 |
2020/01/27
|
ALEMBIC |
| 212982 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
CREAM;TOPICAL |
0.05% |
Prescription |
No |
Yes |
AB1 |
2020/08/28
|
ENCUBE |