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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761071
Company: SANDOZ INC

Medication Guide

Products on BLA 761071

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYRIMOZ	ADALIMUMAB-ADAZ	40MG/0.8ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761071Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2025	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s031ltr.pdf
07/29/2025	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s024ltr.pdf
05/20/2025	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761071Orig1s022ltr.pdf
06/12/2024	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s021ltr.pdf
04/05/2024	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s019ltr.pdf
09/08/2023	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s016ltr.pdf
04/14/2023	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s015ltr.pdf
03/20/2023	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s014ltr.pdf
07/18/2022	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf
03/28/2022	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s011ltr.pdf
07/18/2022	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf
02/24/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761071Orig1s001ltr.pdf

Labels for BLA 761071

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2025	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s031lbl.pdf
10/16/2025	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s031lbl.pdf
07/29/2025	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s024lbl.pdf
05/20/2025	SUPPL-22	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761071s022lbl.pdf
06/12/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s021lbl.pdf
04/05/2024	SUPPL-19	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s019lbl.pdf
09/08/2023	SUPPL-16	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s016lbl.pdf
04/14/2023	SUPPL-15		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf
03/20/2023	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s014lbl.pdf
07/18/2022	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf
07/18/2022	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf
03/28/2022	SUPPL-11	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s011lbl.pdf
02/24/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf
10/30/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf

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