OTREXUP |
204824 |
001 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
10MG/0.4ML (10MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
001 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
10MG/0.4ML (10MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
002 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
15MG/0.4ML (15MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
002 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
15MG/0.4ML (15MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
003 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
20MG/0.4ML (20MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
003 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
20MG/0.4ML (20MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
004 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
25MG/0.4ML (25MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
004 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
25MG/0.4ML (25MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2013/10/11
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
005 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
7.5MG/0.4ML (7.5MG/0.4ML) |
Yes
|
No
|
2013/10/11
|
2014/11/07
|
OTTER PHARMS |
Discontinued |
OTREXUP |
204824 |
005 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
7.5MG/0.4ML (7.5MG/0.4ML) |
Yes
|
No
|
2013/10/11
|
2014/11/07
|
OTTER PHARMS |
Discontinued |
OTREXUP |
204824 |
006 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
12.5MG/0.4ML (12.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
006 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
12.5MG/0.4ML (12.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
007 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
17.5MG/0.4ML (17.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
007 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
17.5MG/0.4ML (17.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
008 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
22.5MG/0.4ML (22.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP |
204824 |
008 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
22.5MG/0.4ML (22.5MG/0.4ML) |
Yes
|
Yes
|
2013/10/11
|
2016/03/24
|
OTTER PHARMS |
Prescription |
OTREXUP PFS |
204824 |
009 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
10MG/0.4ML (10MG/0.4ML) |
Yes
|
No
|
2013/10/11
|
2017/05/31
|
OTTER PHARMS |
Discontinued |
OTREXUP PFS |
204824 |
009 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
10MG/0.4ML (10MG/0.4ML) |
Yes
|
No
|
2013/10/11
|
2017/05/31
|
OTTER PHARMS |
Discontinued |
OTREXUP PFS |
204824 |
010 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
15MG/0.6ML (15MG/0.6ML) |
Yes
|
No
|
2013/10/11
|
2017/05/31
|
OTTER PHARMS |
Discontinued |
OTREXUP PFS |
204824 |
010 |
NDA |
METHOTREXATE |
SOLUTION;SUBCUTANEOUS |
15MG/0.6ML (15MG/0.6ML) |
Yes
|
No
|
2013/10/11
|
2017/05/31
|
OTTER PHARMS |
Discontinued |