FRESENIUS FDA Approval ANDA 206682

ANDA 206682

FRESENIUS

FDA Drug Application

Application #206682

Application Sponsors

ANDA 206682FRESENIUS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2019-12-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206682
            [companyName] => FRESENIUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-10
        )

)

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