ETON FDA Approval ANDA 214082

ANDA 214082

ETON

FDA Drug Application

Application #214082

Application Sponsors

ANDA 214082ETON

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS500MG/10ML (50MG/ML)0CYSTEINE HYDROCHLORIDECYSTEINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ETON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214082
            [companyName] => ETON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSTEINE HYDROCHLORIDE","activeIngredients":"CYSTEINE HYDROCHLORIDE","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-08
        )

)

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