BLA 761244

BOEHRINGER INGELHEIM PHARMACEUTICALS INC

FDA Drug Application

Application #761244

Documents

• Letter: 2022-09-02
• Label: 2022-09-02
• Medication Guide: 2022-09-02
• Review: 2022-09-30

Application Sponsors

BLA 761244

BOEHRINGER INGELHEIM PHARMACEUTICALS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

900MG

0

SPEVIGO

SPESOLIMAB-SBZO

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-09-01

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

BOEHRINGER INGELHEIM PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761244
            [companyName] => BOEHRINGER INGELHEIM PHARMACEUTICALS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761244s000lbl.pdf#page=11"]
            [products] => [{"drugName":"SPEVIGO","activeIngredients":"SPESOLIMAB-SBZO","strength":"900MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/01\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761244s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761244s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761244Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-01
        )

)