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 |
|---|
| 2001/12/13 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/07/11 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/07/11 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2001/07/11 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/07/11 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/26 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/12/29 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/30 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/21 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/11/20 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1998/11/20 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/11/20 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/13 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/13 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/13 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/13 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/11/10 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/11/10 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/11/10 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1988/03/10 |
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:HYDROCORTISONE 剂型/给药途径:CREAM;TOPICAL 规格:2.5% 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 |
|---|
| 085025 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
PADAGIS US |
| 088250 |
001 |
ANDA |
ANUSOL HC |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
1984/06/06
|
SALIX PHARMS |
| 088799 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
1984/11/09
|
TARO |
| 089414 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
Yes |
AT |
1986/12/16
|
FOUGERA PHARMS INC |
| 089682 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
1988/03/10
|
ACTAVIS MID ATLANTIC |
| 040503 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Discontinued |
No |
No |
AT |
2004/03/12
|
CHARTWELL MOLECULAR |
| 040879 |
001 |
ANDA |
HYDROCORTISONE |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
2010/08/20
|
RISING |
| 080706 |
007 |
ANDA |
ALA-CORT |
HYDROCORTISONE |
CREAM;TOPICAL |
2.5% |
Prescription |
No |
No |
AT |
2016/01/05
|
CROWN LABS |