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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020808
Company: GE HEALTHCARE

Products on NDA 020808

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISIPAQUE 270	IODIXANOL	55%	INJECTABLE;INJECTION	Discontinued	None	No	No
VISIPAQUE 320	IODIXANOL	65.2%	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020808

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020351s057,020808s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020351Orig1s057;020808Orig1s035ltr.pdf
02/18/2022	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf
03/12/2019	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020351Orig1s048, 020808Orig1s028ltr.pdf
04/05/2017	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf
04/05/2017	SUPPL-25	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020808Orig1s025.pdf
07/06/2015	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf
01/18/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
12/18/2003	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808slr004ltr.pdf
09/04/2003	SUPPL-2	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808scp002ltr.pdf
01/28/1999	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf

Labels for NDA 020808

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020351s057,020808s035lbl.pdf
02/18/2022	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf
03/12/2019	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf
04/05/2017	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf
04/05/2017	SUPPL-25	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf
07/06/2015	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf
12/18/2003	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf

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