ANDA 077953

APOTEX INC

FDA Drug Application

Application #077953

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 077953

APOTEX 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	2008-09-15
LABELING; Labeling	SUPPL	3	AP	2010-04-27
LABELING; Labeling	SUPPL	4	AP	2011-05-27
LABELING; Labeling	SUPPL	6	AP	2013-07-18
LABELING; Labeling	SUPPL	7	AP	2012-01-05
LABELING; Labeling	SUPPL	9	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-08-28	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15

TE Codes

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

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77953
            [companyName] => APOTEX 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
        )

)