Application Sponsors
ANDA 209635 | SCIEGEN PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
003 | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
004 | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
005 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | 0 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2020-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2020-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-10-30 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 6 | Null | 15 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209635
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"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"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG 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":"10\/30\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-10-30
)
)