| THIOTEPA |
011683 |
001 |
NDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
1959/03/09
|
Approved Prior to Jan 1, 1982
|
IMMUNEX |
Discontinued |
| THIOTEPA |
075547 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
Yes
|
2001/04/02
|
2001/04/02
|
WEST-WARD PHARMS INT |
Prescription |
| THIOTEPA |
075730 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
2001/04/20
|
2001/04/20
|
TEVA PARENTERAL |
Discontinued |
| THIOTEPA |
075730 |
002 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
2001/04/20
|
2001/04/20
|
TEVA PARENTERAL |
Discontinued |
| THIOTEPA |
075698 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
2001/09/20
|
2001/09/20
|
FRESENIUS KABI USA |
Discontinued |
| THIOTEPA |
209150 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
2018/05/04
|
2018/05/04
|
HENGRUI PHARMA |
Prescription |
| THIOTEPA |
210337 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
2018/05/04
|
2018/05/04
|
DR REDDYS |
Prescription |
| THIOTEPA |
208242 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
2020/01/10
|
2020/01/10
|
PENN LIFE |
Prescription |
| THIOTEPA |
213049 |
001 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
No
|
No
|
2020/03/04
|
2020/03/04
|
MSN |
Prescription |
| THIOTEPA |
213049 |
002 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
No
|
No
|
2020/03/04
|
2020/03/04
|
MSN |
Prescription |
| THIOTEPA |
214222 |
001 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
No
|
No
|
2021/03/08
|
2021/03/08
|
GLAND PHARMA LTD |
Prescription |
| THIOTEPA |
214222 |
002 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
No
|
No
|
2021/03/08
|
2022/01/03
|
GLAND PHARMA LTD |
Prescription |
| THIOTEPA |
211831 |
001 |
ANDA |
THIOTEPA |
INJECTABLE;INJECTION |
15MG/VIAL |
No
|
No
|
2021/12/08
|
2021/12/08
|
BELOTECA |
Prescription |
| THIOTEPA |
211755 |
001 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
No
|
No
|
2023/09/05
|
2023/09/05
|
HIKMA |
Prescription |
| THIOTEPA |
216037 |
001 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
No
|
No
|
2023/12/26
|
2023/12/26
|
KINDOS |
Prescription |
| THIOTEPA |
216037 |
002 |
ANDA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
No
|
No
|
2023/12/26
|
2023/12/26
|
KINDOS |
Prescription |