ANDA 077493

PRINSTON INC

FDA Drug Application

Application #077493

Application Sponsors

ANDA 077493

PRINSTON 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	2011-11-29
LABELING; Labeling	SUPPL	2	AP	2017-01-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-01-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-11-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-11-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-10-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77493
            [companyName] => PRINSTON 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
        )

)