ANDA 091261

APOTEX INC

FDA Drug Application

Application #091261

Documents

• Letter: 2011-09-28

Application Sponsors

ANDA 091261

APOTEX INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET, EXTENDED RELEASE;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2011-09-12
LABELING; Labeling	SUPPL	3	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-09-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-09-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-09-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-09-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-09-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-09-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91261
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)