AMNEAL FDA Approval ANDA 211549

ANDA 211549

AMNEAL

FDA Drug Application

Application #211549

Application Sponsors

ANDA 211549AMNEAL

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS, SUBCUTANEOUS100MG/VIAL0AZACITIDINEAZACITIDINE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211549
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)

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