AUROBINDO PHARMA LTD FDA Approval ANDA 216845

ANDA 216845

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216845

Documents

Letter2022-11-28

Application Sponsors

ANDA 216845AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 500MG BASE0DICLOXACILLIN SODIUMDICLOXACILLIN SODIUM
002CAPSULE;ORALEQ 500MG BASE0DICLOXACILLIN SODIUMDICLOXACILLIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-09-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216845
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOXACILLIN SODIUM","activeIngredients":"DICLOXACILLIN SODIUM","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DICLOXACILLIN SODIUM","activeIngredients":"DICLOXACILLIN SODIUM","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)

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