HIKMA FDA Approval ANDA 213561

ANDA 213561

HIKMA

FDA Drug Application

Application #213561

Application Sponsors

ANDA 213561HIKMA

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL8MG/20ML (0.4MG/ML)0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213561
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"8MG\/20ML (0.4MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-01
        )

)

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