NDA 214487

CHEMOCENTRYX, INC.

FDA Drug Application

Application #214487

Documents

• Letter: 2021-10-12
• Label: 2021-10-12
• Medication Guide: 2021-10-12
• Review: 2021-11-04
• Label: 2022-07-07
• Letter: 2022-07-07

Application Sponsors

NDA 214487

CHEMOCENTRYX, INC.

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

TAVNEOS

AVACOPAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-10-07

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CHEMOCENTRYX, INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214487
            [companyName] => CHEMOCENTRYX, INC.
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/214487s000lbl.pdf#page=17"]
            [products] => [{"drugName":"TAVNEOS","activeIngredients":"AVACOPAN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214487s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214487s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214487Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-07
        )

)