ZUBSOLV |
204242 |
001 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 1.4MG BASE;EQ 0.36MG BASE |
Yes
|
No
|
2013/07/03
|
2013/07/03
|
OREXO US INC |
Prescription |
ZUBSOLV |
204242 |
002 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 5.7MG BASE;EQ 1.4MG BASE |
Yes
|
No
|
2013/07/03
|
2013/07/03
|
OREXO US INC |
Prescription |
ZUBSOLV |
204242 |
003 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 8.6MG BASE;EQ 2.1MG BASE |
Yes
|
No
|
2013/07/03
|
2014/12/11
|
OREXO US INC |
Prescription |
ZUBSOLV |
204242 |
004 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 11.4MG BASE;EQ 2.9MG BASE |
Yes
|
Yes
|
2013/07/03
|
2014/12/11
|
OREXO US INC |
Prescription |
ZUBSOLV |
204242 |
005 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 2.9MG BASE;EQ 0.71MG BASE |
Yes
|
No
|
2013/07/03
|
2015/06/04
|
OREXO US INC |
Prescription |
ZUBSOLV |
204242 |
006 |
NDA |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TABLET;SUBLINGUAL |
EQ 0.7MG BASE;EQ 0.18MG BASE |
Yes
|
No
|
2013/07/03
|
2016/10/04
|
OREXO US INC |
Prescription |