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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761058
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYLTEZO ADALIMUMAB-ADBM 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
08/25/2017 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761058Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2023 SUPPL-25 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s025ltr.pdf
06/30/2023 SUPPL-18 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf
05/18/2023 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s016ltr.pdf
10/03/2022 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761058Orig1s014ltr.pdf
03/22/2023 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s013ltr.pdf
03/18/2022 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761058Orig1s011ltr.pdf
10/15/2021 SUPPL-8 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761058Orig1s008ltr.pdf
09/13/2019 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761058Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/19/2023 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058Orig1s025lbl.pdf
06/30/2023 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf
05/18/2023 SUPPL-16 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s016lbl.pdf
03/22/2023 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s013lbl.pdf
10/03/2022 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s014lbl.pdf
03/18/2022 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s011lbl.pdf
10/15/2021 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf
09/13/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf
08/25/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf
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