ANDA 078106

PRINSTON INC

FDA Drug Application

Application #078106

Application Sponsors

ANDA 078106

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	250MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
003	TABLET;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM
004	TABLET;ORAL	1GM	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-02-10
LABELING; Labeling	SUPPL	2	AP	2010-10-28
LABELING; Labeling	SUPPL	6	AP	2014-09-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-09-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-09-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2023-01-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2023-01-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2023-01-05	STANDARD
LABELING; Labeling	SUPPL	17	AP	2023-01-05	STANDARD

Submissions Property Types

SUPPL	6	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78106
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)