BLA 761150

MACROGENICS INC

FDA Drug Application

Application #761150

Documents

• Letter: 2020-12-21
• Label: 2020-12-17
• Review: 2021-01-15

Application Sponsors

BLA 761150

MACROGENICS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MG/10ML(25MG/ML)

2

MARGENZA

MARGETUXIMAB-CMKB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

MACROGENICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761150
            [companyName] => MACROGENICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MARGENZA","activeIngredients":"MARGETUXIMAB-CMKB","strength":"250MG\/10ML(25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761150Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)