ANDA 091338

TORRENT PHARMS LTD

FDA Drug Application

Application #091338

Documents

• Review: 2012-06-22

Application Sponsors

ANDA 091338

TORRENT PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 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	2012-05-29
LABELING; Labeling	SUPPL	5	AP	2014-11-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-09-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-09-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	15	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91338
            [companyName] => TORRENT PHARMS LTD
            [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
        )

)