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 |
|---|
| 2024/04/05 |
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:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:5MG/VIAL 治疗等效代码:AP
| 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 |
|---|
| 064144 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
Yes |
AP |
1998/04/30
|
ACCORD HLTHCARE |
| 064180 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
1999/12/23
|
HIKMA |
| 202670 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
2017/10/13
|
RK PHARMA |
| 215687 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/20
|
GLAND PHARMA LTD |
| 214505 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
2022/09/08
|
MEITHEAL |
| 216732 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
2023/10/30
|
EUGIA PHARMA |
| 211269 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
Prescription |
No |
No |
AP |
2024/04/05
|
FRESENIUS KABI USA |
活性成分:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/VIAL 治疗等效代码:AP
| 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 |
|---|
| 064117 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
1995/04/19
|
HIKMA |
| 064144 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
Yes |
AP |
1998/04/30
|
ACCORD HLTHCARE |
| 064180 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
1999/12/23
|
HIKMA |
| 202670 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2017/10/13
|
RK PHARMA |
| 215687 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/20
|
GLAND PHARMA LTD |
| 214505 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2022/09/08
|
MEITHEAL |
| 216732 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2023/10/30
|
EUGIA PHARMA |
| 211269 |
002 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2024/04/05
|
FRESENIUS KABI USA |
活性成分:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/VIAL 治疗等效代码:AP
| 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 |
|---|
| 064117 |
003 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
1999/06/02
|
HIKMA |
| 064144 |
003 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
Yes |
AP |
2009/08/11
|
ACCORD HLTHCARE |
| 203386 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
2017/10/13
|
RK PHARMA |
| 214504 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
2022/09/06
|
MEITHEAL |
| 216648 |
001 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
2022/11/22
|
GLAND PHARMA LTD |
| 216732 |
003 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
2023/10/30
|
EUGIA PHARMA |
| 211269 |
003 |
ANDA |
MITOMYCIN |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
Prescription |
No |
No |
AP |
2024/04/05
|
FRESENIUS KABI USA |