ANDA 078909

TORRENT

FDA Drug Application

Application #078909

Application Sponsors

ANDA 078909

TORRENT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

RISPERIDONE

RISPERIDONE

FDA Submissions

	ORIG	1	AP	2009-07-29
LABELING; Labeling	SUPPL	2	AP	2011-01-11
LABELING; Labeling	SUPPL	3	AP	2011-04-25
LABELING; Labeling	SUPPL	6	AP	2011-11-10
LABELING; Labeling	SUPPL	7	AP	2011-11-10
LABELING; Labeling	SUPPL	8	AP	2011-11-10
LABELING; Labeling	SUPPL	9	AP	2012-03-01

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78909
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)