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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211675
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RINVOQ UPADACITINIB 15MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
RINVOQ UPADACITINIB 30MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
RINVOQ UPADACITINIB 45MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/16/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211675Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211675Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2022 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s010ltr.pdf
12/02/2021 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675orig1s008ltr.pdf
03/16/2022 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s007ltr.pdf
12/14/2021 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf
01/14/2022 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s004ltr.pdf
04/29/2022 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s003ltr.pdf
12/14/2021 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf
07/10/2020 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211675Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2022 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf
04/29/2022 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf
03/16/2022 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf
01/14/2022 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf
12/14/2021 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/14/2021 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/14/2021 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/02/2021 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf
12/02/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf
07/10/2020 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf
07/10/2020 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf
08/16/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf
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