ANDA 210479

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210479

Application Sponsors

ANDA 210479

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

ARIPIPRAZOLE

ARIPIPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AA

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210479
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/04\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-05
        )

)