ALKEM LABS LTD FDA Approval ANDA 211749

ANDA 211749

ALKEM LABS LTD

FDA Drug Application

Application #211749

Application Sponsors

ANDA 211749ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL100MG/5ML0OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211749
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-04
        )

)

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