ANDA 204094

APOTEX INC

FDA Drug Application

Application #204094

Application Sponsors

ANDA 204094

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

ARIPIPRAZOLE

ARIPIPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-09-30
LABELING; Labeling	SUPPL	2	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-02-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-02-01	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-12-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-12-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	31
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AA

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204094
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/18\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-05
        )

)