Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | TABLET;ORAL | 2.5MG | 1 | ZYPREXA | OLANZAPINE |
| 002 | TABLET;ORAL | 5MG | 1 | ZYPREXA | OLANZAPINE |
| 003 | TABLET;ORAL | 7.5MG | 1 | ZYPREXA | OLANZAPINE |
| 004 | TABLET;ORAL | 10MG | 1 | ZYPREXA | OLANZAPINE |
| 005 | TABLET;ORAL | 15MG | 1 | ZYPREXA | OLANZAPINE |
| 006 | TABLET;ORAL | 20MG | 1 | ZYPREXA | OLANZAPINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-04-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-09-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-12-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2000-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1999-01-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2000-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-01-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2003-07-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2004-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2005-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2005-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2006-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2006-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2006-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2005-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2006-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2006-11-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2009-03-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 40 | AP | 2009-12-04 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2009-12-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 2007-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2007-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2008-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2009-08-31 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 52 | AP | 2010-01-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 53 | AP | 2010-05-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 55 | AP | 2010-05-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 57 | AP | 2010-12-01 | 901 REQUIRED |
| REMS; REMS | SUPPL | 60 | AP | 2011-06-21 | N/A |
| REMS; REMS | SUPPL | 61 | AP | 2011-06-21 | N/A |
| LABELING; Labeling | SUPPL | 62 | AP | 2014-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 63 | AP | 2013-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2015-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2013-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2013-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2016-10-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 68 | AP | 2017-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 71 | AP | 2018-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2019-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2020-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2020-04-21 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 26 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 4 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 55 | Null | 6 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 63 | Null | 6 |
| SUPPL | 64 | Null | 7 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 68 | Null | 6 |
| SUPPL | 69 | Null | 7 |
| SUPPL | 71 | Null | 7 |
| SUPPL | 72 | Null | 33 |
| SUPPL | 74 | Null | 7 |
| SUPPL | 75 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20592
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)