CHARTWELL RX FDA Approval ANDA 077831

ANDA 077831

CHARTWELL RX

FDA Drug Application

Application #077831

Application Sponsors

ANDA 077831CHARTWELL RX

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL100MG0CILOSTAZOLCILOSTAZOL
002TABLET;ORAL50MG0CILOSTAZOLCILOSTAZOL

FDA Submissions

ORIG1AP2012-09-24

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CHARTWELL RX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77831
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CILOSTAZOL","activeIngredients":"CILOSTAZOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CILOSTAZOL","activeIngredients":"CILOSTAZOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CILOSTAZOL","submission":"CILOSTAZOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CILOSTAZOL","submission":"CILOSTAZOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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