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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761058
Company: BOEHRINGER INGELHEIM

Medication Guide

Products on BLA 761058

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761058Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761058s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761058Orig1s026ltr.pdf
07/19/2023	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s025ltr.pdf
06/30/2023	SUPPL-18	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf
05/18/2023	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s016ltr.pdf
10/03/2022	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761058Orig1s014ltr.pdf
03/22/2023	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s013ltr.pdf
03/18/2022	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s011ltr.pdf
10/15/2021	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761058Orig1s008ltr.pdf
09/13/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761058Orig1s003ltr.pdf

Labels for BLA 761058

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-26	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761058s026lbl.pdf
07/19/2023	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058Orig1s025lbl.pdf
06/30/2023	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf
05/18/2023	SUPPL-16	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s016lbl.pdf
03/22/2023	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s013lbl.pdf
10/03/2022	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s014lbl.pdf
03/18/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s011lbl.pdf
10/15/2021	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf
09/13/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf
08/25/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf

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