BLA 021878

NOVO NORDISK

FDA Drug Application

Application #021878

Documents

• Label: 2020-03-23
• Letter: 2020-03-23
• Review: 2020-03-23
• Other: 2020-04-02

Application Sponsors

BLA 021878

NOVO NORDISK

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

100 UNITS/ML

0

LEVEMIR

INSULIN DETEMIR

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2005-10-19

STANDARD

CDER Filings

NOVO NORDISK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21878
            [companyName] => NOVO NORDISK
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVEMIR","activeIngredients":"INSULIN DETEMIR","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/19\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021878lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEVEMIR","submission":"INSULIN DETEMIR","actionType":"100 UNITS\/ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-10-19
        )

)