ANDA 078904

DR REDDYS LABS LTD

FDA Drug Application

Application #078904

Application Sponsors

ANDA 078904

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1GM

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2009-01-15
LABELING; Labeling	SUPPL	2	AP	2010-09-21
REMS; REMS	SUPPL	3	AP	2011-09-27
LABELING; Labeling	SUPPL	4	AP	2012-04-26

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78904
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)