ANDA 076996

ACTAVIS LABS FL INC

FDA Drug Application

Application #076996

Application Sponsors

ANDA 076996

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	0	RISPERIDONE	RISPERIDONE
002	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	0	RISPERIDONE	RISPERIDONE
003	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	0	RISPERIDONE	RISPERIDONE
004	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	0	RISPERIDONE	RISPERIDONE
005	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	0	RISPERIDONE	RISPERIDONE

FDA Submissions

	ORIG	1	AP	2011-04-19
LABELING; Labeling	SUPPL	2	AP	2020-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76996
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)