ANDA 078516

ZYDUS PHARMS USA

FDA Drug Application

Application #078516

Application Sponsors

ANDA 078516

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 003

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	0	RISPERIDONE	RISPERIDONE
003	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	0	RISPERIDONE	RISPERIDONE

FDA Submissions

	ORIG	1	AP	2009-05-01
LABELING; Labeling	SUPPL	2	AP	2010-12-29
LABELING; Labeling	SUPPL	3	AP	2011-06-10
LABELING; Labeling	SUPPL	4	AP	2011-07-11
LABELING; Labeling	SUPPL	5	AP	2012-07-25
LABELING; Labeling	SUPPL	6	AP	2012-04-30
LABELING; Labeling	SUPPL	7	AP	2013-04-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-11-02	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-11-26	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78516
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)