Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | 1 | ZYPREXA ZYDIS | OLANZAPINE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 1 | ZYPREXA ZYDIS | OLANZAPINE |
| 003 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | 1 | ZYPREXA ZYDIS | OLANZAPINE |
| 004 | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | 1 | ZYPREXA ZYDIS | OLANZAPINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-04-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2006-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2005-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2006-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2006-11-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2009-03-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 2007-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2007-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2008-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-08-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 31 | AP | 2010-01-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 32 | AP | 2010-05-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-05-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 36 | AP | 2010-12-01 | 901 REQUIRED |
| REMS; REMS | SUPPL | 38 | AP | 2011-06-21 | N/A |
| REMS; REMS | SUPPL | 39 | AP | 2011-06-21 | N/A |
| LABELING; Labeling | SUPPL | 40 | AP | 2014-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2013-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2015-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2016-10-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 44 | AP | 2017-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 46 | AP | 2018-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2019-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2020-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2020-04-21 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 21 | Null | 4 |
| SUPPL | 22 | Null | 4 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 47 | Null | 33 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 49 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21086
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)