XIROMED FDA Approval ANDA 215046

ANDA 215046

XIROMED

FDA Drug Application

Application #215046

Application Sponsors

ANDA 215046XIROMED

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0CYANOCOBALAMINCYANOCOBALAMIN

FDA Submissions

UNKNOWN; ORIG1AP2021-08-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215046
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)

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