NDA 215014

APELLIS PHARMACEUTICALS INC

FDA Drug Application

Application #215014

Documents

• Label: 2021-05-17
• Letter: 2021-05-17
• Review: 2021-06-01

Application Sponsors

NDA 215014

APELLIS PHARMACEUTICALS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1080MG/20ML(54MG/ML)

0

EMPAVELI

PEGCETACOPLAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-05-14

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

APELLIS PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215014
            [companyName] => APELLIS PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAVELI","activeIngredients":"PEGCETACOPLAN","strength":"1080MG\/20ML(54MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215014s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215014s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215014Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-14
        )

)