ANDA 090347

TARO

FDA Drug Application

Application #090347

Application Sponsors

ANDA 090347

TARO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

RISPERIDONE

RISPERIDONE

FDA Submissions

	ORIG	1	AP	2011-02-07
LABELING; Labeling	SUPPL	2	AP	2012-03-01

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90347
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)