MICRO LABS LTD FDA Approval ANDA 212179

ANDA 212179

MICRO LABS LTD

FDA Drug Application

Application #212179

Application Sponsors

ANDA 212179MICRO LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL50MG0DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUM

FDA Submissions

UNKNOWN; ORIG1TA2019-09-13STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MICRO LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212179
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-13
        )

)

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