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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 022090

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022090s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2024	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022090s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022090Orig1s024ltr.pdf
12/28/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022090Orig1s020ltr.pdf
12/01/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022090Orig1s019ltr.pdf
11/02/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s016,201277Orig1s016ltr.pdf
07/26/2018	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s015,201277Orig1s015Ltr.pdf
04/26/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022090Orig1s014ltredt.pdf
10/26/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/27/2015	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022090s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022090Orig1s011ltr.pdf
01/16/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/16/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022090s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022090Orig1s008ltr.pdf
11/16/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022090s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022090s005ltr.pdf
12/20/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022090s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022090s004ltr.pdf
02/04/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/13/2009	SUPPL-2	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf

Labels for NDA 022090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf
07/26/2018	SUPPL-15	Labeling-Package Insert	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

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