ACCORD HLTHCARE FDA Approval ANDA 213236

ANDA 213236

ACCORD HLTHCARE

FDA Drug Application

Application #213236

Application Sponsors

ANDA 213236ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS0.4MG/5ML (0.08MG/ML)0REGADENOSONREGADENOSON

FDA Submissions

UNKNOWN; ORIG1AP2022-04-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213236
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"0.4MG\/5ML (0.08MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-11
        )

)

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