ALKEM LABS LTD FDA Approval ANDA 210534

ANDA 210534

ALKEM LABS LTD

FDA Drug Application

Application #210534

Application Sponsors

ANDA 210534ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL125MG/5ML0CEFDINIRCEFDINIR
002FOR SUSPENSION;ORAL250MG/5ML0CEFDINIRCEFDINIR

FDA Submissions

UNKNOWN; ORIG1AP2021-02-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210534
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFDINIR","activeIngredients":"CEFDINIR","strength":"125MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFDINIR","activeIngredients":"CEFDINIR","strength":"250MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-19
        )

)

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