U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761255
Company: FRESENIUS KABI USA
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
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)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255Orig2s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761255Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761255Orig2s000TOC.cfm
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
06/04/2024 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761255Orig1s006ltr.pdf
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/04/2024 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255s006lbl.pdf
06/04/2024 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255s006lbl.pdf
06/04/2024 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255s006lbl.pdf
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761255s004lbl.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
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
Back to Top