HETERO LABS FDA Approval ANDA 211813

ANDA 211813

HETERO LABS

FDA Drug Application

Application #211813

Application Sponsors

ANDA 211813HETERO LABS

Marketing Status

Prescription001

Application Products

001FOR SUSPENSION;ORAL100MG/5ML0LINEZOLIDLINEZOLID

FDA Submissions

UNKNOWN; ORIG1AP2022-10-31STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211813
            [companyName] => HETERO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"100MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-31
        )

)

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