MYLAN PHARMS INC FDA Approval BLA 210605

BLA 210605

MYLAN PHARMS INC

FDA Drug Application

Application #210605

Documents

Label2020-06-11
Other2020-06-11
Letter2020-06-12

Application Sponsors

BLA 210605MYLAN PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100 UNITS/ML0SEMGLEEINSULIN GLARGINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-06-11STANDARD This Former NDA Was Deemed To Be a BLA

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210605
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEMGLEE","activeIngredients":"INSULIN GLARGINE","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210605s000lbl.pdf\"}]","notes":"This Former NDA Was Deemed To Be a BLA"}]
            [originalApprovals] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210605s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210605Orig1s000ltr.pdf\"}]","notes":"> This Former NDA Was Deemed To Be a BLA"}]
            [supplements] => 
            [actionDate] => 2020-06-11
        )

)

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