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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761042
Company: SANDOZ

Medication Guide

Summary Review

Products on BLA 761042

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERELZI	ETANERCEPT-SZZS	25MG/0.5ML	INJECTABLE; INJECTION	Prescription	None	No	No
ERELZI	ETANERCEPT-SZZS	50MG/ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761042Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761042s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761042Orig1s018ltr.pdf
06/11/2020	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761042s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761042Orig1s012ltr.pdf
10/18/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761042s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761042Orig1s010ltr.pdf
01/26/2018	SUPPL-1	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761042Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761042Orig1s01.pdf

Labels for BLA 761042

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2022	SUPPL-18	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761042s018lbl.pdf
06/11/2020	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761042s012lbl.pdf
10/18/2019	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761042s010lbl.pdf
01/26/2018	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf
01/26/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf
08/30/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf

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