CIPLA LTD FDA Approval ANDA 077518

ANDA 077518

CIPLA LTD

FDA Drug Application

Application #077518

Application Sponsors

ANDA 077518CIPLA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
002TABLET;ORAL10MG0DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE

FDA Submissions

ORIG1AP2011-05-31
LABELING; LabelingSUPPL2AP2019-05-21STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CIPLA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77518
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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