FRESENIUS KABI USA FDA Approval ANDA 091045

ANDA 091045

FRESENIUS KABI USA

FDA Drug Application

Application #091045

Application Sponsors

ANDA 091045FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0METOPROLOL TARTRATEMETOPROLOL TARTRATE

FDA Submissions

ORIG1AP2010-10-25
LABELING; LabelingSUPPL3AP2021-09-15STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91045
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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