NDA 214461

CHIMERIX

FDA Drug Application

Application #214461

Documents

• Letter: 2021-06-07
• Label: 2021-06-11
• Letter: 2021-08-04
• Label: 2021-08-04
• Review: 2022-01-03

Application Sponsors

NDA 214461

CHIMERIX

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL SUSPENSION

10MG/ML

0

TEMBEXA

BRINCIDOFOVIR

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2021-06-04

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

CHIMERIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214461
            [companyName] => CHIMERIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMBEXA","activeIngredients":"BRINCIDOFOVIR","strength":"10MG\/ML","dosageForm":"TABLET; ORAL SUSPENSION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214460Origs000,214461Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-04
        )

)