ANDA 090939

TORRENT PHARMS LTD

FDA Drug Application

Application #090939

Application Sponsors

ANDA 090939

TORRENT PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
002	TABLET;ORAL	EQ 10MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
003	TABLET;ORAL	EQ 20MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE

FDA Submissions

	ORIG	1	AP	2012-09-11
LABELING; Labeling	SUPPL	2	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-08-31	UNKNOWN
LABELING; Labeling	SUPPL	10	AP	2015-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-03-23	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90939
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)