INVAGEN PHARMS FDA Approval ANDA 078604

ANDA 078604

INVAGEN PHARMS

FDA Drug Application

Application #078604

Documents

Letter2011-05-10

Application Sponsors

ANDA 078604INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 5MG BASE0ESCITALOPRAM OXALATEESCITALOPRAM OXALATE
002TABLET;ORALEQ 10MG BASE0ESCITALOPRAM OXALATEESCITALOPRAM OXALATE
003TABLET;ORALEQ 20MG BASE0ESCITALOPRAM OXALATEESCITALOPRAM OXALATE

FDA Submissions

ORIG1AP2012-09-11
LABELING; LabelingSUPPL6AP2015-10-19STANDARD

Submissions Property Types

ORIG1Null7
SUPPL6Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78604
            [companyName] => INVAGEN PHARMS
            [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
        )

)

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