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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761071
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYRIMOZ ADALIMUMAB-ADAZ 40MG/0.8ML INJECTABLE;INJECTION 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
10/30/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761071Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2024 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s021ltr.pdf
04/05/2024 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761071Orig1s019ltr.pdf
09/08/2023 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s016ltr.pdf
04/14/2023 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s015ltr.pdf
03/20/2023 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761071Orig1s014ltr.pdf
07/18/2022 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf
03/28/2022 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s011ltr.pdf
07/18/2022 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761071Orig1s010,s012ltr.pdf
02/24/2021 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761071Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2024 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s021lbl.pdf
04/05/2024 SUPPL-19 Bioequivalence Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761071s019lbl.pdf
09/08/2023 SUPPL-16 Bioequivalence Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s016lbl.pdf
04/14/2023 SUPPL-15 Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf
03/20/2023 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s014lbl.pdf
07/18/2022 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf
07/18/2022 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf
03/28/2022 SUPPL-11 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s011lbl.pdf
02/24/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf
10/30/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf
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