ANDA 212569

AMNEAL

FDA Drug Application

Application #212569

Documents

• Letter: 2020-05-15

Application Sponsors

ANDA 212569

AMNEAL

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

267MG

0

PIRFENIDONE

PIRFENIDONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212569
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/20\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212569Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-20
        )

)