ANDA 202645

ACTAVIS LABS FL INC

FDA Drug Application

Application #202645

Documents

• Letter: 2015-08-06

Application Sponsors

ANDA 202645

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	1.5MG	0	PALIPERIDONE	PALIPERIDONE
002	TABLET, EXTENDED RELEASE;ORAL	3MG	0	PALIPERIDONE	PALIPERIDONE
003	TABLET, EXTENDED RELEASE;ORAL	6MG	0	PALIPERIDONE	PALIPERIDONE
004	TABLET, EXTENDED RELEASE;ORAL	9MG	0	PALIPERIDONE	PALIPERIDONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-03
LABELING; Labeling	SUPPL	5	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202645
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"6MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"9MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202645Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/16\/2021","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-11-16
        )

)