MSN LABORATORIES PRIVATE LTD FDA Approval ANDA 214921

ANDA 214921

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214921

Application Sponsors

ANDA 214921MSN LABORATORIES PRIVATE LTD

Marketing Status

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

Application Products

002TABLET;ORAL25MG0BRIVARACETAMBRIVARACETAM
003TABLET;ORAL50MG0BRIVARACETAMBRIVARACETAM
004TABLET;ORAL75MG0BRIVARACETAMBRIVARACETAM
005TABLET;ORAL100MG0BRIVARACETAMBRIVARACETAM

FDA Submissions

UNKNOWN; ORIG1TA2022-04-20STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN LABORATORIES PRIVATE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214921
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [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":"04\/20\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-20
        )

)

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