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 |
|---|
| 2021/12/23 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/19 |
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 CYPIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/ML 治疗等效代码:AO
| 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 |
|---|
| 085635 |
002 |
ANDA |
DEPO-TESTOSTERONE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
Yes |
Yes |
AO |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 040615 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AO |
2006/08/10
|
SANDOZ |
| 090387 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AO |
2010/07/15
|
HIKMA |
| 201720 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Discontinued |
No |
No |
AO |
2013/06/03
|
SUN PHARM INDS LTD |
| 210362 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AO |
2018/06/19
|
CIPLA |
| 215351 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AO |
2023/04/13
|
XIROMED |
| 211817 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AO |
2023/10/20
|
EUGIA PHARMA |
活性成分:TESTOSTERONE CYPIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/ML 治疗等效代码:AO
| 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 |
|---|
| 211817 |
003 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
--
|
EUGIA PHARMA |
| 085635 |
003 |
ANDA |
DEPO-TESTOSTERONE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
Yes |
Yes |
AO |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 086030 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Discontinued |
No |
No |
AO |
Approved Prior to Jan 1, 1982
|
WATSON PHARMS INC |
| 040530 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2005/01/31
|
PADAGIS US |
| 040615 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2006/08/10
|
SANDOZ |
| 090387 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2010/07/15
|
HIKMA |
| 091244 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2012/05/01
|
HIKMA FARMACEUTICA |
| 201720 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Discontinued |
No |
No |
AO |
2013/06/03
|
SUN PHARM INDS LTD |
| 207742 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2017/06/16
|
AM REGENT |
| 210362 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2018/06/19
|
CIPLA |
| 206368 |
001 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2019/04/24
|
WILSHIRE PHARMS INC |
| 215351 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2023/04/13
|
XIROMED |
| 211817 |
002 |
ANDA |
TESTOSTERONE CYPIONATE |
TESTOSTERONE CYPIONATE |
INJECTABLE;INJECTION |
200MG/ML |
Prescription |
No |
No |
AO |
2023/10/20
|
EUGIA PHARMA |