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 |
2019/07/25 |
SUPPL-27(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2017/06/19 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2016/06/21 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2016/03/18 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/02/05 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/10/29 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/08/29 |
SUPPL-18(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/07/28 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/02/26 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/11/07 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/11/07 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/28 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/11/30 |
SUPPL-12(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2012/10/17 |
SUPPL-10(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2009/03/20 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/05/09 |
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:BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 剂型/给药途径:SUSPENSION;TOPICAL 规格:0.064%;0.005% 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 |
022185 |
001 |
NDA |
TACLONEX |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
SUSPENSION;TOPICAL |
0.064%;0.005% |
Prescription |
Yes |
Yes |
AB |
2008/05/09
|
LEO PHARMA AS |
210765 |
001 |
ANDA |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
SUSPENSION;TOPICAL |
0.064%;0.005% |
Prescription |
No |
No |
AB |
2020/05/11
|
COSETTE |
213269 |
001 |
ANDA |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
SUSPENSION;TOPICAL |
0.064%;0.005% |
Prescription |
No |
No |
AB |
2020/09/02
|
TARO |
212367 |
001 |
ANDA |
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
SUSPENSION;TOPICAL |
0.064%;0.005% |
Prescription |
No |
No |
AB |
2020/09/11
|
PADAGIS ISRAEL |