APOTEX INC FDA Approval ANDA 214875

ANDA 214875

APOTEX INC

FDA Drug Application

Application #214875

Application Sponsors

ANDA 214875APOTEX INC

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2022-07-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214875
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-12
        )

)

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