EXXUA |
021164 |
001 |
NDA |
GEPIRONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 18.2MG BASE |
Yes
|
No
|
2023/09/22
|
2023/09/22
|
FABRE KRAMER |
Prescription |
EXXUA |
021164 |
002 |
NDA |
GEPIRONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 36.3MG BASE |
Yes
|
No
|
2023/09/22
|
2023/09/22
|
FABRE KRAMER |
Prescription |
EXXUA |
021164 |
003 |
NDA |
GEPIRONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 54.5MG BASE |
Yes
|
No
|
2023/09/22
|
2023/09/22
|
FABRE KRAMER |
Prescription |
EXXUA |
021164 |
004 |
NDA |
GEPIRONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 72.6MG BASE |
Yes
|
Yes
|
2023/09/22
|
2023/09/22
|
FABRE KRAMER |
Prescription |