ALEMBIC PHARMS LTD FDA Approval ANDA 212708

ANDA 212708

ALEMBIC PHARMS LTD

FDA Drug Application

Application #212708

Application Sponsors

ANDA 212708ALEMBIC PHARMS LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2021-10-27STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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