APOTEX INC FDA Approval ANDA 078449

ANDA 078449

APOTEX INC

FDA Drug Application

Application #078449

Application Sponsors

ANDA 078449APOTEX INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL0.5MG0ALPRAZOLAMALPRAZOLAM
002TABLET, EXTENDED RELEASE;ORAL2MG0ALPRAZOLAMALPRAZOLAM
003TABLET, EXTENDED RELEASE;ORAL3MG0ALPRAZOLAMALPRAZOLAM
004TABLET, EXTENDED RELEASE;ORAL1MG0ALPRAZOLAMALPRAZOLAM

FDA Submissions

ORIG1AP2008-11-12
LABELING; LabelingSUPPL2AP2015-12-23
LABELING; LabelingSUPPL3AP2013-01-28STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null15
SUPPL3Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78449
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"0.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"2MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"3MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALPRAZOLAM","submission":"ALPRAZOLAM","actionType":"1MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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