INVEGA |
021999 |
001 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
3MG |
Yes
|
No
|
2006/12/19
|
2006/12/19
|
JANSSEN PHARMS |
Prescription |
INVEGA |
021999 |
002 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
6MG |
Yes
|
Yes
|
2006/12/19
|
2006/12/19
|
JANSSEN PHARMS |
Prescription |
INVEGA |
021999 |
003 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
9MG |
Yes
|
No
|
2006/12/19
|
2006/12/19
|
JANSSEN PHARMS |
Prescription |
INVEGA |
021999 |
004 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/12/19
|
2006/12/19
|
JANSSEN PHARMS |
Discontinued |
INVEGA |
021999 |
006 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE;ORAL |
1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/12/19
|
2008/08/26
|
JANSSEN PHARMS |
Discontinued |
INVEGA |
022043 |
001 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE; ORAL |
3MG |
No
|
No
|
2007/04/27
|
--
|
JANSSEN LP |
Prescription |
INVEGA |
022043 |
002 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE; ORAL |
6MG |
No
|
No
|
2007/04/27
|
--
|
JANSSEN LP |
Prescription |
INVEGA |
022043 |
003 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE; ORAL |
9MG |
No
|
No
|
2007/04/27
|
--
|
JANSSEN LP |
Prescription |
INVEGA |
022043 |
004 |
NDA |
PALIPERIDONE |
TABLET, EXTENDED RELEASE; ORAL |
12MG |
No
|
No
|
2007/04/27
|
--
|
JANSSEN LP |
Prescription |
INVEGA SUSTENNA |
022264 |
001 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
39MG/0.25ML (39MG/0.25ML) |
Yes
|
No
|
2009/07/31
|
2009/07/31
|
JANSSEN PHARMS |
Prescription |
INVEGA SUSTENNA |
022264 |
002 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
78MG/0.5ML (78MG/0.5ML) |
Yes
|
No
|
2009/07/31
|
2009/07/31
|
JANSSEN PHARMS |
Prescription |
INVEGA SUSTENNA |
022264 |
003 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
117MG/0.75ML (117MG/0.75ML) |
Yes
|
No
|
2009/07/31
|
2009/07/31
|
JANSSEN PHARMS |
Prescription |
INVEGA SUSTENNA |
022264 |
004 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
156MG/ML (156MG/ML) |
Yes
|
Yes
|
2009/07/31
|
2009/07/31
|
JANSSEN PHARMS |
Prescription |
INVEGA SUSTENNA |
022264 |
005 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
234MG/1.5ML (156MG/ML) |
Yes
|
No
|
2009/07/31
|
2009/07/31
|
JANSSEN PHARMS |
Prescription |
INVEGA TRINZA |
207946 |
001 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
273MG/0.875ML (273MG/0.875ML) |
Yes
|
Yes
|
2015/05/18
|
2015/05/18
|
JANSSEN PHARMS |
Prescription |
INVEGA TRINZA |
207946 |
002 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
410MG/1.315ML (311.79MG/ML) |
Yes
|
Yes
|
2015/05/18
|
2015/05/18
|
JANSSEN PHARMS |
Prescription |
INVEGA TRINZA |
207946 |
003 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
546MG/1.75ML (312MG/ML) |
Yes
|
Yes
|
2015/05/18
|
2015/05/18
|
JANSSEN PHARMS |
Prescription |
INVEGA TRINZA |
207946 |
004 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
819MG/2.625ML (312MG/ML) |
Yes
|
Yes
|
2015/05/18
|
2015/05/18
|
JANSSEN PHARMS |
Prescription |
INVEGA HAFYERA |
207946 |
005 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
1.092GM/3.5ML (312MG/ML) |
Yes
|
No
|
2015/05/18
|
2021/08/30
|
JANSSEN PHARMS |
Prescription |
INVEGA HAFYERA |
207946 |
006 |
NDA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
1.560GM/5ML (312MG/ML) |
Yes
|
No
|
2015/05/18
|
2021/08/30
|
JANSSEN PHARMS |
Prescription |