LUPIN LTD FDA Approval ANDA 211653

ANDA 211653

LUPIN LTD

FDA Drug Application

Application #211653

Application Sponsors

ANDA 211653LUPIN LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 10MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
002TABLET;ORALEQ 20MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-04-15STANDARD
LABELING; LabelingSUPPL2AP2021-09-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211653
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-15
        )

)

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