ANDA 212708

ALEMBIC PHARMS LTD

FDA Drug Application

Application #212708

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 212708

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 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

2021-10-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212708
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-27
        )

)