NDA 214801

TAIHO ONCOLOGY

FDA Drug Application

Application #214801

Documents

• Letter: 2022-10-03
• Label: 2022-10-05
• Review: 2022-11-08

Application Sponsors

NDA 214801

TAIHO ONCOLOGY

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FILM COATED

4MG

0

LYTGOBI

FUTIBATINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-09-30

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

TAIHO ONCOLOGY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214801
            [companyName] => TAIHO ONCOLOGY
            [docInserts] => ["",""]
            [products] => [{"drugName":"LYTGOBI","activeIngredients":"FUTIBATINIB","strength":"4MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214801Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-30
        )

)