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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1999/02/28 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2006/07/11 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/06/16 |
SUPPL-15（补充） |
Approval |
Labeling-Container/Carton Labels |
N/A
|
|
|
| 2003/12/29 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2003/10/31 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/11/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2002/10/09 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/10/08 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 2002/05/06 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/02/28 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 2000/11/12 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
与本品治疗等效的药品
>>>活性成分:BETAMETHASONE VALERATE; 剂型/给药途径:AEROSOL, FOAM;TOPICAL; 规格:0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB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 |
|---|
| 020934 |
001 |
NDA |
LUXIQ |
BETAMETHASONE VALERATE |
AEROSOL, FOAM;TOPICAL |
0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
1999/02/28
|
PHARMOBEDIENT |
