Application Sponsors
ANDA 203456 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | 0 | OLANZAPINE | OLANZAPINE |
002 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 0 | OLANZAPINE | OLANZAPINE |
003 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | 0 | OLANZAPINE | OLANZAPINE |
004 | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | 0 | OLANZAPINE | OLANZAPINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-03-16 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 203456
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-03-16
)
)