AJANTA PHARMA LTD FDA Approval ANDA 203957

ANDA 203957

AJANTA PHARMA LTD

FDA Drug Application

Application #203957

Application Sponsors

ANDA 203957AJANTA PHARMA LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE
002CAPSULE, DELAYED REL PELLETS;ORAL30MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2016-10-14
LABELING; LabelingSUPPL2AP2021-11-09STANDARD
LABELING; LabelingSUPPL5AP2021-11-09STANDARD
LABELING; LabelingSUPPL6AP2021-11-09STANDARD
LABELING; LabelingSUPPL7AP2021-11-09STANDARD
LABELING; LabelingSUPPL10AP2021-11-09STANDARD
LABELING; LabelingSUPPL12AP2021-11-09STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL5Null7
SUPPL6Null15
SUPPL7Null15
SUPPL10Null7
SUPPL12Null7

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203957
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-14
        )

)

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