LUPIN LTD FDA Approval ANDA 210689

ANDA 210689

LUPIN LTD

FDA Drug Application

Application #210689

Application Sponsors

ANDA 210689LUPIN LTD

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUSEQ 150MG BASE/VIAL0FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN; ORIG1AP2019-09-05STANDARD
LABELING; LabelingSUPPL2AP2021-01-06STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAP

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210689
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-05
        )

)

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