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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022066
Company: GE HEALTHCARE

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMNISCAN	GADODIAMIDE	14.35GM/50ML (287MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OMNISCAN	GADODIAMIDE	28.7GM/100ML (287MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022066s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s051,022066s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020123Orig1s051;022066Orig1s014ltr.pdf
01/26/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s050,022066s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020123Orig1s050; 022066Orig1s013ltr.pdf
08/14/2024	SUPPL-12	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020123Orig1s049, 022066Orig1s012ltr.pdf
10/23/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022066s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022066Orig1s010ltr.pdf
11/07/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s047,022066s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s047,022066Orig1s009ltredt.pdf
04/26/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s046,022066Orig1s008Ltr.pdf
11/14/2014	SUPPL-7	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf
12/11/2012	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf
05/14/2014	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
08/27/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039,%20022066Orig1s004ltr.pdf
12/20/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf

Labels for NDA 022066

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s051,022066s014lbl.pdf
01/26/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s050,022066s013lbl.pdf
10/23/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022066s010lbl.pdf
11/07/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s047,022066s009lbl.pdf
04/26/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf
11/14/2014	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf
08/27/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf
12/20/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf
09/05/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf

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