NATCO PHARMA LTD FDA Approval ANDA 077141

ANDA 077141

NATCO PHARMA LTD

FDA Drug Application

Application #077141

Application Sponsors

ANDA 077141NATCO PHARMA LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

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

FDA Submissions

ORIG1AP2008-04-10
LABELING; LabelingSUPPL2AP2011-01-21

CDER Filings

NATCO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77141
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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