ANDA 090079

LANNETT CO INC

FDA Drug Application

Application #090079

Application Sponsors

ANDA 090079

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2012-04-11
LABELING; Labeling	SUPPL	4	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-02-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-02-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-02-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-02-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90079
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)