ANDA 091537

MYLAN PHARMS INC

FDA Drug Application

Application #091537

Application Sponsors

ANDA 091537

MYLAN PHARMS INC

Marketing Status

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

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
006	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	0	RISPERIDONE	RISPERIDONE

FDA Submissions

	ORIG	1	AP	2011-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-02-12
LABELING; Labeling	SUPPL	3	AP	2013-03-22
LABELING; Labeling	SUPPL	4	AP	2012-12-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91537
            [companyName] => MYLAN PHARMS 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"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.25MG","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"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.25MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)