ALKEM LABS LTD FDA Approval ANDA 210568

ANDA 210568

ALKEM LABS LTD

FDA Drug Application

Application #210568

Application Sponsors

ANDA 210568ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 100MG BASE0CEFPODOXIME PROXETILCEFPODOXIME PROXETIL
002TABLET;ORALEQ 200MG BASE0CEFPODOXIME PROXETILCEFPODOXIME PROXETIL

FDA Submissions

UNKNOWN; ORIG1AP2022-05-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210568
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFPODOXIME PROXETIL","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFPODOXIME PROXETIL","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-18
        )

)

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