ANDA 078583

APOTEX INC

FDA Drug Application

Application #078583

Application Sponsors

ANDA 078583

APOTEX INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	2MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
002	TABLET;ORAL	5MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
003	TABLET;ORAL	10MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
004	TABLET;ORAL	15MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
005	TABLET;ORAL	20MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE
006	TABLET;ORAL	30MG	0	ARIPIPRAZOLE	ARIPIPRAZOLE

FDA Submissions

	ORIG	1	AP	2015-07-24
LABELING; Labeling	SUPPL	2	AP	2022-12-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-12-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-12-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-12-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-12-16	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78583
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ARIPIPRAZOLE","submission":"ARIPIPRAZOLE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)