ZYDUS PHARMS USA FDA Approval ANDA 214501

ANDA 214501

ZYDUS PHARMS USA

FDA Drug Application

Application #214501

Documents

Letter2021-07-14

Application Sponsors

ANDA 214501ZYDUS PHARMS USA

Marketing Status

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

Application Products

001TABLET;ORAL10MG0BRIVARACETAMBRIVARACETAM
002TABLET;ORAL25MG0BRIVARACETAMBRIVARACETAM
003TABLET;ORAL50MG0BRIVARACETAMBRIVARACETAM
004TABLET;ORAL75MG0BRIVARACETAMBRIVARACETAM
005TABLET;ORAL100MG0BRIVARACETAMBRIVARACETAM

FDA Submissions

UNKNOWN; ORIG1TA2021-06-11STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214501
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)

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