Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | OLANZAPINE | OLANZAPINE |
002 | TABLET;ORAL | 5MG | 0 | OLANZAPINE | OLANZAPINE |
003 | TABLET;ORAL | 7.5MG | 0 | OLANZAPINE | OLANZAPINE |
004 | TABLET;ORAL | 10MG | 0 | OLANZAPINE | OLANZAPINE |
005 | TABLET;ORAL | 15MG | 0 | OLANZAPINE | OLANZAPINE |
006 | TABLET;ORAL | 20MG | 0 | OLANZAPINE | OLANZAPINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-01-27 | |
LABELING; Labeling | SUPPL | 3 | AP | 2021-11-18 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-11-18 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2021-11-18 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 15 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
QILU
cder:Array
(
[0] => Array
(
[ApplNo] => 204319
[companyName] => QILU
[docInserts] => ["",""]
[products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-01-27
)
)