BLA 761216

COHERUS BIOSCIENCES INC

FDA Drug Application

Application #761216

Documents

• Label: 2021-12-20
• Medication Guide: 2021-12-19
• Letter: 2021-12-21
• Review: 2022-01-18

Application Sponsors

BLA 761216

COHERUS BIOSCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG

0

YUSIMRY

ADALIMUMAB-AQVH

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2021-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

COHERUS BIOSCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761216
            [companyName] => COHERUS BIOSCIENCES INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761216s000lbl.pdf#page=38"]
            [products] => [{"drugName":"YUSIMRY","activeIngredients":"ADALIMUMAB-AQVH","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","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\\\/761216s000lbl.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\\\/761216s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761216Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)