Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761255
Company: FRESENIUS KABI USA
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-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 | |
11/16/2023 | SUPPL-4 | Labeling-Container/Carton Labels | 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 |