ALEMBIC GLOBAL HOLDING SA FDA Approval ANDA 211574

ANDA 211574

ALEMBIC GLOBAL HOLDING SA

FDA Drug Application

Application #211574

Application Sponsors

ANDA 211574ALEMBIC GLOBAL HOLDING SA

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2020-09-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALEMBIC GLOBAL HOLDING SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211574
            [companyName] => ALEMBIC GLOBAL HOLDING SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-03
        )

)

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