GRANULES INDIA FDA Approval ANDA 212615

ANDA 212615

GRANULES INDIA

FDA Drug Application

Application #212615

Application Sponsors

ANDA 212615GRANULES INDIA

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL267MG0PIRFENIDONEPIRFENIDONE
002TABLET;ORAL801MG0PIRFENIDONEPIRFENIDONE

FDA Submissions

UNKNOWN; ORIG1TA2021-05-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

GRANULES INDIA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212615
            [companyName] => GRANULES INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIRFENIDONE","activeIngredients":"PIRFENIDONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-12
        )

)

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