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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207924
Company: ELI LILLY AND CO

Medication Guide

Products on NDA 207924

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLUMIANT	BARICITINIB	2MG	TABLET;ORAL	Prescription	AB	Yes	No
OLUMIANT	BARICITINIB	1MG	TABLET;ORAL	Prescription	AB	Yes	No
OLUMIANT	BARICITINIB	4MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207924

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

Labels for NDA 207924

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

Therapeutic Equivalents for NDA 207924

OLUMIANT

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLUMIANT	BARICITINIB	2MG	TABLET;ORAL	Prescription	Yes	AB	207924	ELI LILLY AND CO

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OLUMIANT	BARICITINIB	1MG	TABLET;ORAL	Prescription	Yes	AB	207924	ELI LILLY AND CO

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