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 |
|---|
| 2019/02/13 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/06/27 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/01/21 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/11/05 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1998/11/05 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/11/05 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/11/05 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/03/31 |
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:CLOBETASOL PROPIONATE 剂型/给药途径:OINTMENT;TOPICAL 规格:0.05% 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 |
|---|
| 074089 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
1994/02/16
|
COSETTE |
| 074221 |
001 |
ANDA |
EMBELINE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Discontinued |
No |
No |
AB |
1995/03/31
|
HIKMA |
| 074407 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
1996/02/23
|
FOUGERA PHARMS |
| 074248 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
1996/07/12
|
TARO |
| 075057 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
1998/08/12
|
AUROBINDO PHARMA USA |
| 208933 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2017/03/20
|
GLENMARK SPECLT |
| 210199 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2017/10/27
|
ZYDUS PHARMS |
| 209701 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2018/04/17
|
XIROMED |
| 208841 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2018/05/04
|
NOVEL LABS INC |
| 208589 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Discontinued |
No |
No |
AB |
2019/01/23
|
PAI HOLDINGS PHARM |
| 211800 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2019/03/04
|
ALEMBIC |
| 211295 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
Yes |
AB |
2019/11/15
|
ENCUBE |
| 215990 |
001 |
ANDA |
CLOBETASOL PROPIONATE |
CLOBETASOL PROPIONATE |
OINTMENT;TOPICAL |
0.05% |
Prescription |
No |
No |
AB |
2023/12/28
|
MACLEODS PHARMS LTD |