QILU FDA Approval ANDA 215316

ANDA 215316

QILU

FDA Drug Application

Application #215316

Application Sponsors

ANDA 215316QILU

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS500MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2021-08-24STANDARD
LABELING; LabelingSUPPL2AP2022-11-13STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAP

CDER Filings

QILU
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215316
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-24
        )

)

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