ANDA 079120

BRECKENRIDGE

FDA Drug Application

Application #079120

Documents

• Letter: 2009-01-21

Application Sponsors

ANDA 079120

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-01-16
LABELING; Labeling	SUPPL	2	AP	2010-02-25
LABELING; Labeling	SUPPL	3	AP	2010-04-26
LABELING; Labeling	SUPPL	5	AP	2015-02-18
LABELING; Labeling	SUPPL	6	AP	2015-02-18
LABELING; Labeling	SUPPL	7	AP	2015-02-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-02-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-02-18	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7

TE Codes

001

Prescription

AA

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79120
            [companyName] => BRECKENRIDGE
            [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
        )

)