INTL MEDICATION SYS FDA Approval ANDA 212461

ANDA 212461

INTL MEDICATION SYS

FDA Drug Application

Application #212461

Application Sponsors

ANDA 212461INTL MEDICATION SYS

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-06STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAA

CDER Filings

INTL MEDICATION SYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212461
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"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":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-06
        )

)

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