ANDA 090263

LANNETT CO INC

FDA Drug Application

Application #090263

Documents

• Other Important Information from FDA: 2009-04-14

Application Sponsors

ANDA 090263

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-04-03
LABELING; Labeling	SUPPL	2	AP	2010-02-19
LABELING; Labeling	SUPPL	3	AP	2010-10-25
LABELING; Labeling	SUPPL	7	AP	2012-07-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-08-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-08-01	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90263
            [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
        )

)