GLAND PHARMA LTD FDA Approval ANDA 207831

ANDA 207831

GLAND PHARMA LTD

FDA Drug Application

Application #207831

Application Sponsors

ANDA 207831GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)0CLOFARABINECLOFARABINE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-31STANDARD
LABELING; LabelingSUPPL2AP2021-04-14STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207831
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOFARABINE","activeIngredients":"CLOFARABINE","strength":"20MG\/20ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-31
        )

)

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