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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761255
Company: FRESENIUS KABI USA

Medication Guide

Products on BLA 761255

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761255

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2024	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255Orig2s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761255Orig2s000ltr.pdf
12/13/2022	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761255s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761255Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2023	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761255Orig1s004ltr.pdf
10/31/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761255Orig1s003ltr.pdf
10/11/2023	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761255Orig1s002ltr.pdf

Labels for BLA 761255

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2024	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255Orig2s000Lbl.pdf
11/16/2023	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s004lbl.pdf
11/16/2023	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s004lbl.pdf
11/16/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s004lbl.pdf
10/31/2023	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s003lbl.pdf
10/11/2023	SUPPL-2		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s002lbl.pdf
12/13/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761255s000lbl.pdf

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