MAKRO TECHNLOGIES, INC FDA Approval ANDA 212747

ANDA 212747

MAKRO TECHNLOGIES, INC

FDA Drug Application

Application #212747

Documents

Letter2022-02-04

Application Sponsors

ANDA 212747MAKRO TECHNLOGIES, INC

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN; ORIG1TA2022-01-21STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MAKRO TECHNLOGIES, INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212747
            [companyName] => MAKRO TECHNLOGIES, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"534MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212747Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-21
        )

)

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