DR REDDYS LABS LTD FDA Approval ANDA 210465

ANDA 210465

DR REDDYS LABS LTD

FDA Drug Application

Application #210465

Application Sponsors

ANDA 210465DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE
002TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210465
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-01
        )

)

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