ANDA 078976

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #078976

Documents

• Letter: 2009-01-21

Application Sponsors

ANDA 078976

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-01-15
REMS; REMS	SUPPL	3	AP	2010-02-16
LABELING; Labeling	SUPPL	4	AP	2010-11-17
LABELING; Labeling	SUPPL	6	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-09-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-09-26	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	15

TE Codes

001

Prescription

AA

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78976
            [companyName] => ACTAVIS MID ATLANTIC
            [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
        )

)