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 |
|---|
| 2024/11/05 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
ORIG-1（原始申请） |
Approval |
|
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:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.25GM/PACKET) 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 |
|---|
| 022038 |
001 |
NDA |
DIVIGEL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
Yes |
Yes |
AB |
2007/06/04
|
VERTICAL PHARMS |
| 211783 |
001 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
No |
No |
AB |
2022/08/10
|
CHEMO RESEARCH SL |
| 217610 |
001 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
No |
No |
AB |
2023/08/24
|
NOVITIUM PHARMA |
| 216524 |
001 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
No |
No |
AB |
2023/11/14
|
PADAGIS ISRAEL |
| 217863 |
001 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
QUAGEN |
| 216055 |
001 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.25GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
AMNEAL |
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.5GM/PACKET) 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 |
|---|
| 022038 |
002 |
NDA |
DIVIGEL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
Yes |
Yes |
AB |
2007/06/04
|
VERTICAL PHARMS |
| 211783 |
002 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
No |
No |
AB |
2022/08/10
|
CHEMO RESEARCH SL |
| 217610 |
002 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
No |
No |
AB |
2023/08/24
|
NOVITIUM PHARMA |
| 216524 |
002 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
No |
No |
AB |
2023/11/14
|
PADAGIS ISRAEL |
| 217863 |
002 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
QUAGEN |
| 216055 |
002 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.5GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
AMNEAL |
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (0.75GM/PACKET) 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 |
|---|
| 022038 |
004 |
NDA |
DIVIGEL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.75GM/PACKET) |
Prescription |
Yes |
Yes |
AB |
2018/08/17
|
VERTICAL PHARMS |
| 217610 |
003 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.75GM/PACKET) |
Prescription |
No |
No |
AB |
2023/08/24
|
NOVITIUM PHARMA |
| 216524 |
003 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.75GM/PACKET) |
Prescription |
No |
No |
AB |
2023/11/14
|
PADAGIS ISRAEL |
| 217863 |
003 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.75GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
QUAGEN |
| 216055 |
003 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (0.75GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
AMNEAL |
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (1GM/PACKET) 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 |
|---|
| 022038 |
003 |
NDA |
DIVIGEL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
Yes |
Yes |
AB |
2007/06/04
|
VERTICAL PHARMS |
| 211783 |
003 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
No |
No |
AB |
2022/08/10
|
CHEMO RESEARCH SL |
| 217610 |
004 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
No |
No |
AB |
2023/08/24
|
NOVITIUM PHARMA |
| 216524 |
004 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
No |
No |
AB |
2023/11/14
|
PADAGIS ISRAEL |
| 217863 |
004 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
QUAGEN |
| 216055 |
004 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
AMNEAL |
活性成分:ESTRADIOL 剂型/给药途径:GEL;TRANSDERMAL 规格:0.1% (1.25GM/PACKET) 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 |
|---|
| 022038 |
005 |
NDA |
DIVIGEL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1.25GM/PACKET) |
Prescription |
Yes |
Yes |
AB |
2019/12/12
|
VERTICAL PHARMS |
| 217610 |
005 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1.25GM/PACKET) |
Prescription |
No |
No |
AB |
2023/08/24
|
NOVITIUM PHARMA |
| 216524 |
005 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1.25GM/PACKET) |
Prescription |
No |
No |
AB |
2023/11/14
|
PADAGIS ISRAEL |
| 217863 |
005 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1.25GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
QUAGEN |
| 216055 |
005 |
ANDA |
ESTRADIOL |
ESTRADIOL |
GEL;TRANSDERMAL |
0.1% (1.25GM/PACKET) |
Prescription |
No |
No |
AB |
2024/07/12
|
AMNEAL |