ANDA 212687

APOTEX INC

FDA Drug Application

Application #212687

Documents

• Letter: 2019-12-03

Application Sponsors

ANDA 212687

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

267MG

0

PIRFENIDONE

PIRFENIDONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-10-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212687
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212687Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-29
        )

)