AUROBINDO PHARMA LTD FDA Approval ANDA 213665

ANDA 213665

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213665

Application Sponsors

ANDA 213665AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL250MG0FLUCYTOSINEFLUCYTOSINE
002CAPSULE;ORAL500MG0FLUCYTOSINEFLUCYTOSINE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-01STANDARD
LABELING; LabelingSUPPL2AP2022-09-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213665
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCYTOSINE","activeIngredients":"FLUCYTOSINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCYTOSINE","activeIngredients":"FLUCYTOSINE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)

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