Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAMUSCULAR | 10MG/VIAL | 1 | ZYPREXA | OLANZAPINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2006-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | 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 | 21 | AP | 2006-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2007-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2008-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2009-08-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2010-01-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2010-05-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2010-05-27 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2014-09-30 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2010-12-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 48 | AP | 2014-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2015-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2014-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2016-10-27 | N/A |
| LABELING; Labeling | SUPPL | 56 | AP | 2016-10-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 57 | AP | 2017-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 59 | AP | 2018-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2019-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2020-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2020-04-21 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 26 | Null | 4 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 49 | Null | 15 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 56 | Null | 6 |
| SUPPL | 57 | Null | 6 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 59 | Null | 15 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 6 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21253
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)