ACCORD HLTHCARE INC FDA Approval ANDA 209877

ANDA 209877

ACCORD HLTHCARE INC

FDA Drug Application

Application #209877

Documents

Letter2018-02-09

Application Sponsors

ANDA 209877ACCORD HLTHCARE INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

001TABLET;ORAL2MG0PERAMPANELPERAMPANEL
002TABLET;ORAL4MG0PERAMPANELPERAMPANEL
003TABLET;ORAL6MG0PERAMPANELPERAMPANEL
004TABLET;ORAL8MG0PERAMPANELPERAMPANEL
005TABLET;ORAL10MG0PERAMPANELPERAMPANEL
006TABLET;ORAL12MG0PERAMPANELPERAMPANEL

FDA Submissions

UNKNOWN; ORIG1TA2018-01-30STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

ACCORD HLTHCARE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209877
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/30\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209877Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-30
        )

)

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