ABILIFY |
021436 |
001 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
10MG |
Yes
|
Yes
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021436 |
002 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
15MG |
Yes
|
No
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021436 |
003 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
20MG |
Yes
|
No
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021436 |
004 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
30MG |
Yes
|
No
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021436 |
005 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
5MG |
Yes
|
No
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021436 |
006 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
2MG |
Yes
|
No
|
2002/11/15
|
2002/11/15
|
OTSUKA |
Prescription |
ABILIFY |
021713 |
001 |
NDA |
ARIPIPRAZOLE |
SOLUTION;ORAL |
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2004/12/10
|
2004/12/10
|
OTSUKA |
Discontinued |
ABILIFY |
021729 |
002 |
NDA |
ARIPIPRAZOLE |
TABLET, ORALLY DISINTEGRATING;ORAL |
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/06/07
|
2006/06/07
|
OTSUKA |
Discontinued |
ABILIFY |
021729 |
003 |
NDA |
ARIPIPRAZOLE |
TABLET, ORALLY DISINTEGRATING;ORAL |
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/06/07
|
2006/06/07
|
OTSUKA |
Discontinued |
ABILIFY |
021729 |
004 |
NDA |
ARIPIPRAZOLE |
TABLET, ORALLY DISINTEGRATING;ORAL |
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/06/07
|
2006/06/07
|
OTSUKA |
Discontinued |
ABILIFY |
021729 |
005 |
NDA |
ARIPIPRAZOLE |
TABLET, ORALLY DISINTEGRATING;ORAL |
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2006/06/07
|
2006/06/07
|
OTSUKA |
Discontinued |
ABILIFY |
021866 |
001 |
NDA |
ARIPIPRAZOLE |
INJECTABLE;INTRAMUSCULAR |
9.75MG/1.3ML (7.5MG/ML) |
No
|
No
|
2006/09/20
|
2006/09/20
|
OTSUKA |
Discontinued |
ABILIFY MAINTENA KIT |
202971 |
001 |
NDA |
ARIPIPRAZOLE |
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
300MG/VIAL |
Yes
|
No
|
2013/02/28
|
2013/02/28
|
OTSUKA PHARM CO LTD |
Prescription |
ABILIFY MAINTENA KIT |
202971 |
002 |
NDA |
ARIPIPRAZOLE |
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
400MG/VIAL |
Yes
|
Yes
|
2013/02/28
|
2013/02/28
|
OTSUKA PHARM CO LTD |
Prescription |
ABILIFY MAINTENA KIT |
202971 |
003 |
NDA |
ARIPIPRAZOLE |
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
300MG |
Yes
|
No
|
2013/02/28
|
2014/09/29
|
OTSUKA PHARM CO LTD |
Prescription |
ABILIFY MAINTENA KIT |
202971 |
004 |
NDA |
ARIPIPRAZOLE |
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
400MG |
Yes
|
No
|
2013/02/28
|
2014/09/29
|
OTSUKA PHARM CO LTD |
Prescription |
ABILIFY MYCITE KIT |
207202 |
001 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
2MG |
Yes
|
No
|
2017/11/13
|
2017/11/13
|
OTSUKA |
Prescription |
ABILIFY MYCITE KIT |
207202 |
002 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
5MG |
Yes
|
Yes
|
2017/11/13
|
2017/11/13
|
OTSUKA |
Prescription |
ABILIFY MYCITE KIT |
207202 |
003 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
10MG |
Yes
|
No
|
2017/11/13
|
2017/11/13
|
OTSUKA |
Prescription |
ABILIFY MYCITE KIT |
207202 |
004 |
NDA |
ARIPIPRAZOLE |
TABLET;ORAL |
15MG |
Yes
|
No
|
2017/11/13
|
2017/11/13
|
OTSUKA |
Prescription |