Application Sponsors
ANDA 207655 | AUROBINDO PHARMA LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
003 | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
004 | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
005 | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2019-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2021-11-01 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-11-01 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-11-01 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207655
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-20
)
)