INVAGEN PHARMS FDA Approval ANDA 077534

ANDA 077534

INVAGEN PHARMS

FDA Drug Application

Application #077534

Application Sponsors

ANDA 077534INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 10MG BASE0CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDE
002TABLET;ORALEQ 20MG BASE0CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDE
003TABLET;ORALEQ 40MG BASE0CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDE

FDA Submissions

ORIG1AP2006-10-03
LABELING; LabelingSUPPL2AP2009-08-21
LABELING; LabelingSUPPL4AP2012-04-25
LABELING; LabelingSUPPL6AP2013-04-26STANDARD
LABELING; LabelingSUPPL9AP2015-03-09STANDARD
LABELING; LabelingSUPPL10AP2015-03-09STANDARD
LABELING; LabelingSUPPL14AP2022-11-21STANDARD
LABELING; LabelingSUPPL17AP2022-11-21STANDARD
LABELING; LabelingSUPPL19AP2022-11-21STANDARD
LABELING; LabelingSUPPL20AP2022-11-21STANDARD

Submissions Property Types

SUPPL2Null7
SUPPL4Null8
SUPPL6Null15
SUPPL9Null15
SUPPL10Null7
SUPPL14Null7
SUPPL17Null7
SUPPL19Null7
SUPPL20Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77534
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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