ANDA 201519

TORRENT

FDA Drug Application

Application #201519

Application Sponsors

ANDA 201519

TORRENT

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

UNKNOWN;	ORIG	1	AP	2015-04-28
LABELING; Labeling	SUPPL	27	AP	2016-10-18	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-10-18	STANDARD
LABELING; Labeling	SUPPL	31	AP	2016-10-18	STANDARD
LABELING; Labeling	SUPPL	33	AP	2019-04-05	STANDARD
LABELING; Labeling	SUPPL	35	AP	2019-04-05	STANDARD
LABELING; Labeling	SUPPL	36	AP	2019-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	27	Null	15
SUPPL	29	Null	15
SUPPL	31	Null	15
SUPPL	33	Null	15
SUPPL	35	Null	7
SUPPL	36	Null	15

TE Codes

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

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201519
            [companyName] => TORRENT
            [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":"04\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/05\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-05
        )

)