ANDA 078828

JUBILANT CADISTA

FDA Drug Application

Application #078828

Documents

• Other Important Information from FDA: 2009-04-14

Application Sponsors

ANDA 078828

JUBILANT CADISTA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	0.25MG	0	RISPERIDONE	RISPERIDONE
002	TABLET;ORAL	0.5MG	0	RISPERIDONE	RISPERIDONE
003	TABLET;ORAL	1MG	0	RISPERIDONE	RISPERIDONE
004	TABLET;ORAL	2MG	0	RISPERIDONE	RISPERIDONE
005	TABLET;ORAL	3MG	0	RISPERIDONE	RISPERIDONE
006	TABLET;ORAL	4MG	0	RISPERIDONE	RISPERIDONE

FDA Submissions

	ORIG	1	AP	2009-03-23
LABELING; Labeling	SUPPL	2	AP	2011-06-30

Submissions Property Types

SUPPL

1

Null

8

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78828
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)