MSN LABORATORIES PRIVATE LTD FDA Approval ANDA 214822

ANDA 214822

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #214822

Application Sponsors

ANDA 214822MSN LABORATORIES PRIVATE LTD

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2022-02-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN LABORATORIES PRIVATE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214822
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/1000","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"5MG\/1000","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)

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