Application Sponsors
ANDA 091038 | SUN PHARM INDS | |
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
| ORIG | 1 | AP | 2012-04-23 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-06-17 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 7 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 91038
[companyName] => SUN PHARM INDS
[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":"OLANZAPINE","submission":"OLANZAPINE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)