AUROBINDO PHARMA LTD FDA Approval ANDA 214982

ANDA 214982

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214982

Application Sponsors

ANDA 214982AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL0.0625MG0DIGOXINDIGOXIN
002TABLET;ORAL0.125MG0DIGOXINDIGOXIN
003TABLET;ORAL0.25MG0DIGOXINDIGOXIN

FDA Submissions

UNKNOWN; ORIG1AP2022-02-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214982
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.0625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)

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