ANDA 208438

PHARMTAK INC

FDA Drug Application

Application #208438

Application Sponsors

ANDA 208438

PHARMTAK INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
002	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PHARMTAK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208438
            [companyName] => PHARMTAK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-26
        )

)