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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207924
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLUMIANT BARICITINIB 2MG TABLET;ORAL Prescription None Yes Yes
OLUMIANT BARICITINIB 1MG TABLET;ORAL Prescription None Yes No
OLUMIANT BARICITINIB 4MG TABLET;ORAL Prescription None Yes 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
05/31/2018 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207924Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207924Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2022 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207924Orig1s007ltr.pdf
05/10/2022 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207924Orig1s006ltr.pdf
12/02/2021 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207924s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207924Orig1s004ltr.pdf
07/08/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207924s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207924Orig1s002ltr.pdf
10/08/2019 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207924s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207924Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2022 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf
05/10/2022 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924Orig1s006lbl.pdf
12/02/2021 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207924s004lbl.pdf
12/02/2021 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207924s004lbl.pdf
07/08/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207924s002lbl.pdf
10/08/2019 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207924s001lbl.pdf
05/31/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924Orig1s000lbl.pdf
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