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 |
|---|
| 2005/12/16 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/09/26 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/01/27 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/07/22 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/03/03 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 1995/03/01 |
SUPPL-52（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1992/11/13 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/04/24 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/13 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/12/06 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/02/10 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/08/29 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/09/07 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/04/08 |
SUPPL-43（补充） |
Approval |
Labeling |
|
|
|
| 1982/11/19 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/05/19 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/20 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/16 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/10/23 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 1981/06/26 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/19 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/19 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/19 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/19 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/18 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/23 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/13 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/29 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/01 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 1978/10/12 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1978/09/12 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1978/07/05 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/04/11 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/14 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/09/19 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/06/04 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/01/04 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1976/05/06 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/02/24 |
SUPPL-15（补充） |
Approval |
Supplement |
STANDARD
|
|
|
| 1971/06/30 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
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:FLUOCINONIDE 剂型/给药途径:CREAM;TOPICAL 规格:0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB2
| 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 |
|---|
| 016908 |
003 |
NDA |
LIDEX-E |
FLUOCINONIDE |
CREAM;TOPICAL |
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB2 |
Approved Prior to Jan 1, 1982
|
ALVOGEN |
