MYLAN PHARMS INC FDA Approval ANDA 212953

ANDA 212953

MYLAN PHARMS INC

FDA Drug Application

Application #212953

Documents

Letter2022-08-30

Application Sponsors

ANDA 212953MYLAN PHARMS INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2021-04-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212953
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD","activeIngredients":"FINGOLIMOD","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/02\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-02
        )

)

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