FRESENIUS KABI USA FDA Approval ANDA 200674

ANDA 200674

FRESENIUS KABI USA

FDA Drug Application

Application #200674

Application Sponsors

ANDA 200674FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 250MG/50ML (EQ 5MG/ML)0LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACIN
002INJECTABLE;INJECTIONEQ 500MG/100ML (EQ 5MG/ML)0LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACIN
003INJECTABLE;INJECTIONEQ 750MG/150ML (EQ 5MG/ML)0LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACIN

FDA Submissions

N/A; Not ApplicableORIG1AP2013-06-19
LABELING; LabelingSUPPL3AP2015-10-19STANDARD
LABELING; LabelingSUPPL4AP2019-04-24STANDARD
LABELING; LabelingSUPPL6AP2018-10-18STANDARD
LABELING; LabelingSUPPL8AP2019-05-03STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null15
SUPPL4Null15
SUPPL6Null15
SUPPL8Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200674
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 250MG\/50ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/100ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/150ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-03
        )

)

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