Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022090
Company: BAYER HLTHCARE

• Medication Guide

• Other Important Information from FDA

• Summary Review

Products on NDA 22090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EOVIST	GADOXETATE DISODIUM	1.8143GM/10ML (181.43MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
EOVIST	GADOXETATE DISODIUM	2.72145GM/15ML (181.43MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No

Labels for NDA 022090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/13/2026	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022090s025lbl.pdf
03/05/2025	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022090s027lbl.pdf
07/23/2024	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022090s026lbl.pdf
01/30/2024	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022090s024lbl.pdf
12/28/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf
12/01/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090Orig1s019lbl.pdf
11/02/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s016lbl.pdf
07/26/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf
07/26/2018	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf
04/26/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s014lbl.pdf
03/27/2015	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022090s011lbl.pdf
10/16/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022090s008lbl.pdf
11/16/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022090s005lbl.pdf
12/20/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022090s004lbl.pdf
07/03/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022090lbl.pdf