BLA 761165

COHERUS BIOSCIENCES INC

FDA Drug Application

Application #761165

Documents

• Label: 2022-08-02
• Letter: 2022-08-03
• Review: 2022-08-23

Application Sponsors

BLA 761165

COHERUS BIOSCIENCES INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	0.3MG(6MG/ML)	0	CIMERLI	RANIBIZUMAB-EQRN
002	INJECTABLE;INJECTION	0.5MG(10MG/ML)	0	CIMERLI	RANIBIZUMAB-EQRN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

COHERUS BIOSCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761165
            [companyName] => COHERUS BIOSCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMERLI","activeIngredients":"RANIBIZUMAB-EQRN","strength":"0.3MG(6MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CIMERLI","activeIngredients":"RANIBIZUMAB-EQRN","strength":"0.5MG(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761165s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761165s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761165Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-02
        )

)