ANDA 090187

APOTEX INC

FDA Drug Application

Application #090187

Application Sponsors

ANDA 090187

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2011-08-05
LABELING; Labeling	SUPPL	2	AP	2016-05-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-07-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-07-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-07-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90187
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)