ANDA 212570

AMNEAL

FDA Drug Application

Application #212570

Application Sponsors

ANDA 212570

AMNEAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	267MG	0	PIRFENIDONE	PIRFENIDONE
002	TABLET;ORAL	801MG	0	PIRFENIDONE	PIRFENIDONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212570
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-25
        )

)