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 |
2014/08/01 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/07/01 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/15 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/01 |
SUPPL-4(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/12/14 |
SUPPL-2(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/02/18 |
SUPPL-1(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2008/12/08 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
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:ADAPALENE; BENZOYL PEROXIDE 剂型/给药途径:GEL;TOPICAL 规格:0.1%;2.5% 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 |
022320 |
001 |
NDA |
EPIDUO |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Prescription |
Yes |
Yes |
AB |
2008/12/08
|
GALDERMA LABS LP |
203790 |
001 |
ANDA |
ADAPALENE AND BENZOYL PEROXIDE |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Discontinued |
No |
No |
AB |
2015/09/30
|
ACTAVIS MID ATLANTIC |
205033 |
001 |
ANDA |
ADAPALENE AND BENZOYL PEROXIDE |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Prescription |
No |
No |
AB |
2018/01/23
|
PADAGIS ISRAEL |
206959 |
001 |
ANDA |
ADAPALENE AND BENZOYL PEROXIDE |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Prescription |
No |
No |
AB |
2018/01/24
|
TARO |
206164 |
001 |
ANDA |
ADAPALENE AND BENZOYL PEROXIDE |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Prescription |
No |
No |
AB |
2018/05/23
|
ENCUBE |
208108 |
001 |
ANDA |
ADAPALENE AND BENZOYL PEROXIDE |
ADAPALENE; BENZOYL PEROXIDE |
GEL;TOPICAL |
0.1%;2.5% |
Prescription |
No |
No |
AB |
2019/11/08
|
GLENMARK PHARMS LTD |