ANDA 212731

ACCORD HLTHCARE

FDA Drug Application

Application #212731

Application Sponsors

ANDA 212731

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

267MG

0

PIRFENIDONE

PIRFENIDONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212731
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-20
        )

)