ANDA 091285

SUN PHARM INDUSTRIES

FDA Drug Application

Application #091285

Documents

• Letter: 2011-09-12

Application Sponsors

ANDA 091285

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET, EXTENDED RELEASE;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

	ORIG	1	AP	2011-09-12
LABELING; Labeling	SUPPL	2	AP	2015-01-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91285
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)