MSN LABORATORIES PRIVATE LTD FDA Approval ANDA 211101

ANDA 211101

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #211101

Application Sponsors

ANDA 211101MSN LABORATORIES PRIVATE LTD

Marketing Status

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

Application Products

002TABLET;ORAL10MG0VORTIOXETINE HYDROBROMIDEVORTIOXETINE HYDROBROMIDE
003TABLET;ORAL20MG0VORTIOXETINE HYDROBROMIDEVORTIOXETINE HYDROBROMIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-12-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN LABORATORIES PRIVATE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211101
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-03
        )

)

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