ORENITRAM |
203496 |
001 |
NDA |
TREPROSTINIL DIOLAMINE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 0.125MG BASE |
Yes
|
No
|
2013/12/20
|
2013/12/20
|
UNITED THERAP |
Prescription |
ORENITRAM |
203496 |
002 |
NDA |
TREPROSTINIL DIOLAMINE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 0.25MG BASE |
Yes
|
No
|
2013/12/20
|
2013/12/20
|
UNITED THERAP |
Prescription |
ORENITRAM |
203496 |
003 |
NDA |
TREPROSTINIL DIOLAMINE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 1MG BASE |
Yes
|
Yes
|
2013/12/20
|
2013/12/20
|
UNITED THERAP |
Prescription |
ORENITRAM |
203496 |
004 |
NDA |
TREPROSTINIL DIOLAMINE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2.5MG BASE |
Yes
|
No
|
2013/12/20
|
2013/12/20
|
UNITED THERAP |
Prescription |
ORENITRAM |
203496 |
005 |
NDA |
TREPROSTINIL DIOLAMINE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 5MG BASE |
Yes
|
No
|
2013/12/20
|
2016/10/07
|
UNITED THERAP |
Prescription |