BLA 210605

MYLAN PHARMS INC

FDA Drug Application

Application #210605

Documents

• Label: 2020-06-11
• Other: 2020-06-11
• Letter: 2020-06-12
• Review: 2020-12-21

Application Sponsors

BLA 210605

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100 UNITS/ML

0

SEMGLEE

INSULIN GLARGINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-06-11

STANDARD This Former NDA Was Deemed To Be a BLA

Submissions Property Types

ORIG

1

Null

7

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
        )

)