ALKEM LABS LTD FDA Approval ANDA 210220

ANDA 210220

ALKEM LABS LTD

FDA Drug Application

Application #210220

Application Sponsors

ANDA 210220ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL300MG0CEFDINIRCEFDINIR

FDA Submissions

UNKNOWN; ORIG1AP2021-02-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210220
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFDINIR","activeIngredients":"CEFDINIR","strength":"300MG","dosageForm":"CAPSULE;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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