BLA 761086

AMGEN INC

FDA Drug Application

Application #761086

Documents

• Label: 2019-12-06
• Medication Guide: 2019-12-06
• Letter: 2019-12-10
• Review: 2020-01-30
• Pediatric Other: 1900-01-01
• Label: 2021-09-10
• Letter: 2021-09-14

Application Sponsors

BLA 761086

AMGEN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/VIAL

0

AVSOLA

INFLIXIMAB-AXXQ

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-12-06

STANDARD

Submissions Property Types

ORIG

1

Null

23

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761086
            [companyName] => AMGEN INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761086s000lbl.pdf#page=48"]
            [products] => [{"drugName":"AVSOLA","activeIngredients":"INFLIXIMAB-AXXQ","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761086s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761086s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761086Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761086Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-06
        )

)