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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210450
Company: ABBVIE

Medication Guide

Products on NDA 210450

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORILISSA	ELAGOLIX SODIUM	EQ 150MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ORILISSA	ELAGOLIX SODIUM	EQ 200MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210450s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210450Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210450Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210450s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210450Orig1s009ltr.pdf
02/01/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210450Orig1s004, s005, s006ltr.pdf
02/01/2021	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210450Orig1s004, s005, s006ltr.pdf
02/01/2021	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210450Orig1s004, s005, s006ltr.pdf
08/28/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210450s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210450Orig1s002ltr.pdf

Labels for NDA 210450

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210450s009lbl.pdf
06/05/2023	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210450s009lbl.pdf
02/01/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf
02/01/2021	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf
02/01/2021	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf
08/28/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210450s002lbl.pdf
07/23/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210450s000lbl.pdf

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