BLA 761039

COHERUS BIOSCIENCES INC

FDA Drug Application

Application #761039

Documents

• Label: 2018-11-02
• Letter: 2019-10-21
• Review: 2019-03-05
• Letter: 2019-04-18
• Letter: 2019-10-21
• Label: 2020-01-28
• Label: 2020-02-13
• Letter: 2020-02-13
• Pediatric Medical Review: 1900-01-01
• Pediatric DD Summary Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Letter: 2021-06-08
• Label: 2021-06-08
• Letter: 2022-11-29
• Label: 2022-11-29

Application Sponsors

BLA 761039

COHERUS BIOSCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

6MG/0.6ML

0

UDENYCA

PEGFILGRASTIM-CBQV

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-11-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-06-07	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2022-11-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	10	Null	6
SUPPL	14	Null	6

CDER Filings

COHERUS BIOSCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761039
            [companyName] => COHERUS BIOSCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"UDENYCA","activeIngredients":"PEGFILGRASTIM-CBQV","strength":"6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761039s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761039s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761039s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761039s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761039s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761039s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761039Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761039Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/17\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761039Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761039s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761039Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"04\/16\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761039s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761039Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-02-12
        )

)