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 |
|---|
| 2013/06/28 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/03/26 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/02/25 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/12/10 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/07/01 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/02/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/07/21 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:CICLOPIROX 剂型/给药途径:GEL;TOPICAL 规格:0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB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 |
|---|
| 020519 |
001 |
NDA |
CICLOPIROX |
CICLOPIROX |
GEL;TOPICAL |
0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
1997/07/21
|
ALVOGEN |
