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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761105
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SKYRIZI RISANKIZUMAB-RZAA 75MG/0.83ML INJECTABLE;INJECTION Prescription None No No
SKYRIZI RISANKIZUMAB-RZAA 150MG/ML 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
04/23/2019 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761105s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/2022 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s016ltr.pdf
01/21/2022 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s014ltr.pdf
04/26/2021 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf
04/26/2021 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf
03/20/2020 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761105Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2022 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf
01/21/2022 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf
04/26/2021 SUPPL-10 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf
04/26/2021 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf
03/20/2020 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf
04/23/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf
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