LUPIN LTD FDA Approval ANDA 210748

ANDA 210748

LUPIN LTD

FDA Drug Application

Application #210748

Application Sponsors

ANDA 210748LUPIN LTD

Marketing Status

Discontinued001

Application Products

001POWDER;INTRAVENOUS, SUBCUTANEOUS100MG/VIAL0AZACITIDINEAZACITIDINE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-27STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210748
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-27
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.