An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf
01/26/2018	SUPPL-1	Labeling-Medication Guide	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

Top