| PEMETREXED |
210661 |
001 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
100MG |
No
|
No
|
2018/03/28
(TA)
|
|
APOTEX INC |
None (Tentative Approval) |
| PEMETREXED |
210661 |
002 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
500MG |
No
|
No
|
2018/03/28
(TA)
|
|
APOTEX INC |
None (Tentative Approval) |
| PEMETREXED |
208927 |
001 |
ANDA |
PEMETREXED |
INJECTABLE;INJECTION |
100MG |
No
|
No
|
2018/05/04
(TA)
|
|
BIOCON LTD |
None (Tentative Approval) |
| PEMETREXED |
208927 |
002 |
ANDA |
PEMETREXED |
INJECTABLE;INJECTION |
500MG |
No
|
No
|
2018/05/04
(TA)
|
|
BIOCON LTD |
None (Tentative Approval) |
| PEMETREXED |
090352 |
001 |
ANDA |
PEMETREXED SODIUM |
INJECTABLE;INJECTION |
500MG |
No
|
|
2019/05/20
(TA)
|
|
TEVA PHARMS USA |
None (Tentative Approval) |
| PEMETREXED FOR INJECTION |
208297 |
001 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
100MG |
No
|
No
|
2020/05/14
(TA)
|
|
DR REDDYS LABS INC |
Prescription |
| PEMETREXED FOR INJECTION |
208297 |
002 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
500MG |
No
|
No
|
2020/05/14
(TA)
|
|
DR REDDYS LABS INC |
Prescription |
| PEMETREXED FOR INJECTION |
208297 |
003 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
1G |
No
|
No
|
2020/05/14
(TA)
|
|
DR REDDYS LABS INC |
Prescription |
| PEMETREXED |
208419 |
001 |
NDA |
PEMETREXED |
SOLUTION;INTRAVENOUS |
100MG/4ML (25MG/ML) |
Yes
|
Yes
|
2020/08/21
|
2020/08/21
|
ACTAVIS LLC |
Prescription |
| PEMETREXED |
208419 |
002 |
NDA |
PEMETREXED |
SOLUTION;INTRAVENOUS |
500MG/20ML (25MG/ML) |
Yes
|
Yes
|
2020/08/21
|
2020/08/21
|
ACTAVIS LLC |
Prescription |
| PEMETREXED |
208419 |
003 |
NDA |
PEMETREXED |
SOLUTION;INTRAVENOUS |
1GM/40ML (25MG/ML) |
Yes
|
Yes
|
2020/08/21
|
2020/08/21
|
ACTAVIS LLC |
Prescription |
| PEMETREXED DISODIUM |
090384 |
001 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 100MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
FRESENIUS KABI USA |
Prescription |
| PEMETREXED DISODIUM |
090384 |
002 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 500MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
FRESENIUS KABI USA |
Prescription |
| PEMETREXED DISODIUM |
090384 |
003 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 750MG BASE/VIAL |
No
|
Yes
|
2022/05/25
|
2022/05/25
|
FRESENIUS KABI USA |
Prescription |
| PEMETREXED DISODIUM |
090384 |
004 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 1GM BASE/VIAL |
No
|
Yes
|
2022/05/25
|
2022/05/25
|
FRESENIUS KABI USA |
Prescription |
| PEMETREXED DISODIUM |
202111 |
001 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 100MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
HOSPIRA |
Discontinued |
| PEMETREXED DISODIUM |
202111 |
002 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 500MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
HOSPIRA |
Discontinued |
| PEMETREXED DISODIUM |
202111 |
003 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 1GM BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
HOSPIRA |
Discontinued |
| PEMETREXED DISODIUM |
202596 |
001 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 100MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
DR REDDYS |
Prescription |
| PEMETREXED DISODIUM |
202596 |
002 |
ANDA |
PEMETREXED DISODIUM |
POWDER;INTRAVENOUS |
EQ 500MG BASE/VIAL |
No
|
No
|
2022/05/25
|
2022/05/25
|
DR REDDYS |
Prescription |