Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761024
Company: AMGEN INC

• Medication Guide

Products on BLA 761024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMJEVITA	ADALIMUMAB-ATTO	20MG/0.4ML	INJECTABLE;INJECTION	Prescription	None	No	No
AMJEVITA	ADALIMUMAB-ATTO	40MG/0.8ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761024Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2023	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s017ltr.pdf
08/14/2023	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s015ltr.pdf
03/22/2023	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s012ltr.pdf
04/06/2023	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s011ltr.pdf
07/28/2022	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761024Orig1s010ltr.pdf
06/13/2019	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761024Orig1s004ltr.pdf
03/15/2018	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761024Orig1s003ltr.pdf

Labels for BLA 761024

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2023	SUPPL-15	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf
07/12/2023	SUPPL-17		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s017lbl.pdf
04/06/2023	SUPPL-11	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024Orig1s011lbl.pdf
03/22/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s012lbl.pdf
07/28/2022	SUPPL-10	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf
06/13/2019	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf
06/13/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf
03/15/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf
09/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf