FRESENIUS KABI USA FDA Approval ANDA 206198

ANDA 206198

FRESENIUS KABI USA

FDA Drug Application

Application #206198

Application Sponsors

ANDA 206198FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-07-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206198
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-20
        )

)

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