XIROMED FDA Approval ANDA 203203

ANDA 203203

XIROMED

FDA Drug Application

Application #203203

Application Sponsors

ANDA 203203XIROMED

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2016-07-25
LABELING; LabelingSUPPL2AP2020-08-20STANDARD
LABELING; LabelingSUPPL4AP2020-08-20STANDARD
LABELING; LabelingSUPPL5AP2020-08-20STANDARD
LABELING; LabelingSUPPL6AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL4Null7
SUPPL5Null15
SUPPL6Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203203
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-20
        )

)

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