UMEDICA LABS PVT LTD FDA Approval ANDA 211298

ANDA 211298

UMEDICA LABS PVT LTD

FDA Drug Application

Application #211298

Application Sponsors

ANDA 211298UMEDICA LABS PVT LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2020-07-01UNKNOWN

CDER Filings

UMEDICA LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211298
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)

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