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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761039
Company: COHERUS BIOSCIENCES INC

Products on BLA 761039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UDENYCA	PEGFILGRASTIM-CBQV	6MG/0.6ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761039Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761039Orig1s015ltr.pdf
11/28/2022	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761039s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761039Orig1s014ltr.pdf
03/03/2023	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761039Orig1s013ltr.pdf
06/07/2021	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761039Orig1s010ltr.pdf
10/17/2019	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761039Orig1s004ltr.pdf
02/12/2020	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761039Orig1s003ltr.pdf
04/16/2019	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761039s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761039Orig1s001ltr.pdf

Labels for BLA 761039

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039Orig1s015lbl.pdf
03/03/2023	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039s013lbl.pdf
11/28/2022	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761039s014lbl.pdf
06/07/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf
06/07/2021	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761039s010lbl.pdf
02/12/2020	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf
02/12/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf
02/12/2020	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf
04/16/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761039s001lbl.pdf
11/02/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf

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