LUPIN LTD FDA Approval ANDA 202782

ANDA 202782

LUPIN LTD

FDA Drug Application

Application #202782

Application Sponsors

ANDA 202782LUPIN LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL23MG0DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2015-10-30
LABELING; LabelingSUPPL3AP2019-04-23STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null7

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202782
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-23
        )

)

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