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 |
|---|
| 2020/01/29 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2019/06/04 |
SUPPL-2（补充） |
Approval |
REMS |
|
|
|
| 2019/05/10 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/10/23 |
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:TESTOSTERONE 剂型/给药途径:SOLUTION, METERED;TRANSDERMAL 规格:30MG/1.5ML ACTUATION 治疗等效代码:AT
| 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 |
|---|
| 204255 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
Yes |
AT |
2017/02/28
|
PADAGIS ISRAEL |
| 205328 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
No |
AT |
2017/08/07
|
ACTAVIS LABS UT INC |
| 208061 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
No |
AT |
2017/10/23
|
LUPIN LTD |
| 209533 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
No |
AT |
2018/01/29
|
CIPLA |
| 212301 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
No |
AT |
2021/01/11
|
ENCUBE |
| 209836 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
SOLUTION, METERED;TRANSDERMAL |
30MG/1.5ML ACTUATION |
Prescription |
No |
No |
AT |
2021/09/03
|
TWI PHARMS |
