NDA 214373

THERAXOSBIO LLC

FDA Drug Application

Application #214373

Documents

• Letter: 2023-01-23
• Label: 2023-01-23
• Medication Guide: 2023-01-23

Application Sponsors

NDA 214373

THERAXOSBIO LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

0

BRENZVVY

BEXAGLIFLOZIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2023-01-20

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

THERAXOSBIO LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214373
            [companyName] => THERAXOSBIO LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/214373s000lbl.pdf#page=23"]
            [products] => [{"drugName":"BRENZAVVY","activeIngredients":"BEXAGLIFLOZIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/214373s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/214373s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/214373Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-20
        )

)