美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 24 条
共 2 页，当前第 1 页
| 商品名 |
申请号 |
产品号 |
申请类型 |
活性成分 |
剂型/给药途径 |
规格/剂量 |
RLD |
RS |
申请号原始批准/暂定批准日期 |
产品号批准日期 |
申请人 |
市场状态 |
| MITOMYCIN |
064117 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
1995/04/19
|
1995/04/19
|
HIKMA |
Discontinued |
| MITOMYCIN |
064117 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
1995/04/19
|
1995/04/19
|
HIKMA |
Prescription |
| MITOMYCIN |
064117 |
003 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
No
|
No
|
1995/04/19
|
1999/06/02
|
HIKMA |
Prescription |
| MITOMYCIN |
064106 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
1995/11/29
|
1995/11/29
|
HOSPIRA |
Discontinued |
| MITOMYCIN |
064144 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
Yes
|
1998/04/30
|
1998/04/30
|
ACCORD HLTHCARE |
Prescription |
| MITOMYCIN |
064144 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
Yes
|
1998/04/30
|
1998/04/30
|
ACCORD HLTHCARE |
Prescription |
| MITOMYCIN |
064144 |
003 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
No
|
Yes
|
1998/04/30
|
2009/08/11
|
ACCORD HLTHCARE |
Prescription |
| MITOMYCIN |
064180 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
1999/12/23
|
1999/12/23
|
HIKMA |
Prescription |
| MITOMYCIN |
064180 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
1999/12/23
|
1999/12/23
|
HIKMA |
Prescription |
| MITOMYCIN |
202670 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
2017/10/13
|
2017/10/13
|
RK PHARMA |
Prescription |
| MITOMYCIN |
202670 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
2017/10/13
|
2017/10/13
|
RK PHARMA |
Prescription |
| MITOMYCIN |
203386 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
No
|
No
|
2017/10/13
|
2017/10/13
|
RK PHARMA |
Prescription |
| MITOMYCIN |
215687 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
2021/10/20
|
2021/10/20
|
GLAND PHARMA LTD |
Prescription |
| MITOMYCIN |
215687 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
2021/10/20
|
2021/10/20
|
GLAND PHARMA LTD |
Prescription |
| MITOMYCIN |
214504 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
No
|
No
|
2022/09/06
|
2022/09/06
|
MEITHEAL |
Prescription |
| MITOMYCIN |
214505 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
2022/09/08
|
2022/09/08
|
MEITHEAL |
Prescription |
| MITOMYCIN |
214505 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
2022/09/08
|
2022/09/08
|
MEITHEAL |
Prescription |
| MITOMYCIN |
216648 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
40MG/VIAL |
No
|
No
|
2022/11/22
|
2022/11/22
|
GLAND PHARMA LTD |
Prescription |
| MITOMYCIN |
216732 |
001 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
5MG/VIAL |
No
|
No
|
2023/10/30
|
2023/10/30
|
EUGIA PHARMA |
Prescription |
| MITOMYCIN |
216732 |
002 |
ANDA |
MITOMYCIN |
INJECTABLE;INJECTION |
20MG/VIAL |
No
|
No
|
2023/10/30
|
2023/10/30
|
EUGIA PHARMA |
Prescription |