HETERO LABS LTD V FDA Approval ANDA 212674

ANDA 212674

HETERO LABS LTD V

FDA Drug Application

Application #212674

Application Sponsors

ANDA 212674HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL267MG0PIRFENIDONEPIRFENIDONE
002TABLET;ORAL801MG0PIRFENIDONEPIRFENIDONE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212674
            [companyName] => HETERO LABS LTD V
            [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":"09\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-21
        )

)

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