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 |
|---|
| 2019/11/01 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/05/16 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/04/10 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:GEL, METERED;TRANSDERMAL 规格:1.62% (20.25MG/1.25GM ACTUATION) 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 |
|---|
| 022309 |
001 |
NDA |
ANDROGEL |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
Yes |
Yes |
AB |
2011/04/29
|
BESINS HLTHCARE |
| 204268 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2015/08/04
|
PADAGIS ISRAEL |
| 204570 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2019/04/10
|
ACTAVIS LABS UT INC |
| 207373 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2019/04/10
|
AMNEAL |
| 208560 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2019/04/10
|
LUPIN |
| 208620 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2019/04/10
|
ENCUBE |
| 209390 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2019/09/23
|
TWI PHARMS |
| 210835 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Prescription |
No |
No |
AB |
2020/04/16
|
XIROMED |
活性成分:TESTOSTERONE 剂型/给药途径:GEL;TRANSDERMAL 规格:1.62% (20.25MG/1.25GM PACKET) 治疗等效代码:AB2
| 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 |
|---|
| 205781 |
001 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (20.25MG/1.25GM PACKET) |
Prescription |
No |
No |
AB2 |
2017/07/12
|
PADAGIS ISRAEL |
| 204570 |
002 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (20.25MG/1.25GM PACKET) |
Prescription |
No |
No |
AB2 |
2020/07/17
|
ACTAVIS LABS UT INC |
活性成分:TESTOSTERONE 剂型/给药途径:GEL;TRANSDERMAL 规格:1.62% (40.5MG/2.5GM PACKET) 治疗等效代码:AB2
| 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 |
|---|
| 022309 |
003 |
NDA |
ANDROGEL |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (40.5MG/2.5GM PACKET) |
Prescription |
Yes |
No |
AB2 |
2012/09/07
|
BESINS HLTHCARE |
| 205781 |
002 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (40.5MG/2.5GM PACKET) |
Prescription |
No |
Yes |
AB2 |
2017/07/12
|
PADAGIS ISRAEL |
| 204570 |
003 |
ANDA |
TESTOSTERONE |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (40.5MG/2.5GM PACKET) |
Prescription |
No |
No |
AB2 |
2020/07/17
|
ACTAVIS LABS UT INC |
