ANDA 078614

SUN PHARMA GLOBAL

FDA Drug Application

Application #078614

Application Sponsors

ANDA 078614

SUN PHARMA GLOBAL

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005

Application Products

001	TABLET; ORAL	5MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
002	TABLET; ORAL	10MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
003	TABLET; ORAL	15MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
004	TABLET; ORAL	20MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
005	TABLET; ORAL	30MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE

FDA Submissions

ORIG

1

TA

2013-02-14

Submissions Property Types

ORIG

1

Null

0

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78614
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"30MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"10MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"15MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"20MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"30MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)