BLA 125547

ELI LILLY CO

FDA Drug Application

Application #125547

Documents

• Letter: 2015-11-24
• Label: 2015-11-24
• Review: 2015-12-30
• Summary Review: 2015-12-30

Application Sponsors

BLA 125547

ELI LILLY CO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

800MG/50ML

2

PORTRAZZA

NECITUMUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2015-11-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ELI LILLY CO

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            [docInserts] => ["",""]
            [products] => [{"drugName":"PORTRAZZA","activeIngredients":"NECITUMUMAB","strength":"800MG\/50ML","dosageForm":"INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"11\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125547s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2015-11-24
        )

)