BLA 761171

Y-MABS THERAPEUTICS INC

FDA Drug Application

Application #761171

Documents

• Label: 2020-11-25
• Letter: 2020-11-27
• Review: 2020-12-22

Application Sponsors

BLA 761171

Y-MABS THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

40MG/10ML

0

DANYELZA

NAXITAMAB-GQGK

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-11-25

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

Y-MABS THERAPEUTICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761171
            [companyName] => Y-MABS THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DANYELZA","activeIngredients":"NAXITAMAB-GQGK","strength":"40MG\/10ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761171lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761171lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761171Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)