ANDA 078040

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078040

Application Sponsors

ANDA 078040

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 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	2008-10-16
LABELING; Labeling	SUPPL	2	AP	2010-01-12
LABELING; Labeling	SUPPL	3	AP	2010-12-29
LABELING; Labeling	SUPPL	4	AP	2011-06-08
LABELING; Labeling	SUPPL	8	AP	2011-07-11
LABELING; Labeling	SUPPL	9	AP	2012-01-03
LABELING; Labeling	SUPPL	10	AP	2012-01-03
LABELING; Labeling	SUPPL	11	AP	2012-12-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-08-28	STANDARD

Submissions Property Types

SUPPL	2	Null	8
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78040
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)