Documents
Application Sponsors
Marketing Status
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
CDER Filings
CHIMERIX
cder:Array
(
[0] => Array
(
[ApplNo] => 214460
[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
)
)