MICRO LABS LTD FDA Approval ANDA 212680

ANDA 212680

MICRO LABS LTD

FDA Drug Application

Application #212680

Documents

Letter2020-08-25

Application Sponsors

ANDA 212680MICRO LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET; ORAL267MG0PIRFENIDONEPIRFENIDONE
002TABLET;ORAL801MG0PIRFENIDONEPIRFENIDONE
003TABLET;ORAL534MG0PIRFENIDONEPIRFENIDONE

FDA Submissions

UNKNOWN; ORIG1TA2020-06-04STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MICRO LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212680
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"534MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212680Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-04
        )

)

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