BLA 761224

ASTRAZENECA AB

FDA Drug Application

Application #761224

Documents

• Label: 2021-12-17
• Letter: 2021-12-21
• Review: 2022-01-13

Application Sponsors

BLA 761224

ASTRAZENECA AB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

210MG/1.91ML(110MG/ML)

0

TEZSPIRE

TEZEPELUMAB-EKKO

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-12-17

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761224
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEZSPIRE","activeIngredients":"TEZEPELUMAB-EKKO","strength":"210MG\/1.91ML(110MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761224s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761224s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761224Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)