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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761216
Company: COHERUS BIOSCIENCES INC

Medication Guide

Products on BLA 761216

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YUSIMRY	ADALIMUMAB-AQVH	40MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761216Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761216Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/2023	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761216Orig1s004ltr.pdf
03/31/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761216Orig1s003ltr.pdf
02/27/2023	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761216Orig1s001ltr.pdf

Labels for BLA 761216

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/2023	SUPPL-4	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s004lbl.pdf
03/31/2023	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s003lbl.pdf
02/27/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s001lbl.pdf
12/17/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf

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