MSN LABS PVT LTD FDA Approval ANDA 215389

ANDA 215389

MSN LABS PVT LTD

FDA Drug Application

Application #215389

Documents

Letter2022-09-07

Application Sponsors

ANDA 215389MSN LABS PVT LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL600MG0DARUNAVIRDARUNAVIR
002TABLET;ORAL800MG0DARUNAVIRDARUNAVIR

FDA Submissions

UNKNOWN; ORIG1TA2022-08-24STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215389
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DARUNAVIR","activeIngredients":"DARUNAVIR","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)

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