GLAND PHARMA LTD FDA Approval ANDA 206908

ANDA 206908

GLAND PHARMA LTD

FDA Drug Application

Application #206908

Application Sponsors

ANDA 206908GLAND PHARMA LTD

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

UNKNOWN; ORIG1AP2020-12-30STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206908
            [companyName] => GLAND PHARMA LTD
            [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":"12\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-30
        )

)

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