BAXTER HLTHCARE CORP FDA Approval ANDA 091397

ANDA 091397

BAXTER HLTHCARE CORP

FDA Drug Application

Application #091397

Application Sponsors

ANDA 091397BAXTER HLTHCARE CORP

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

ORIG1AP2013-08-08
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2014-10-20
LABELING; LabelingSUPPL5AP2014-09-23STANDARD
LABELING; LabelingSUPPL9AP2018-10-15STANDARD
LABELING; LabelingSUPPL15AP2018-10-15STANDARD
LABELING; LabelingSUPPL16AP2018-10-18STANDARD
LABELING; LabelingSUPPL18AP2019-05-06STANDARD
LABELING; LabelingSUPPL19AP2019-05-06STANDARD

Submissions Property Types

ORIG1Null1
SUPPL3Null0
SUPPL5Null15
SUPPL9Null15
SUPPL15Null15
SUPPL16Null15
SUPPL18Null15
SUPPL19Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91397
            [companyName] => BAXTER HLTHCARE CORP
            [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":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 250MG\/50ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 500MG\/100ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 750MG\/150ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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