ACCORD HLTHCARE FDA Approval ANDA 212868

ANDA 212868

ACCORD HLTHCARE

FDA Drug Application

Application #212868

Documents

Letter2021-08-16

Application Sponsors

ANDA 212868ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;INTRAVENOUS0.25MG/5ML (0.5MG/ML)0ATROPINE SULFATEATROPINE SULFATE
002SOLUTION;INTRAVENOUS0.5MG/5ML (0.1MG/ML)0ATROPINE SULFATEATROPINE SULFATE
003SOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212868
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.25MG\/5ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"0.5MG\/5ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-26
        )

)

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