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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020608
Company: GE HEALTHCARE

Products on NDA 020608

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMNIPAQUE 240	IOHEXOL	51.8%	SOLUTION;INJECTION, ORAL, RECTAL	Discontinued	None	No	No
OMNIPAQUE 300	IOHEXOL	64.7%	SOLUTION;INJECTION, ORAL, RECTAL	Prescription	None	No	No
OMNIPAQUE 350	IOHEXOL	75.5%	SOLUTION;INJECTION, ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020608

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/1995	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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-49	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116,020608s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018956Orig1s116;020608Orig1s049ltr.pdf
10/08/2024	SUPPL-47	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956Orig1s119,020608Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018956Orig1s119, 020608Orig1s047ltr.pdf
02/18/2022	SUPPL-45	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018956Orig1s113; 020608Orig1s045ltr.pdf
11/09/2017	SUPPL-38	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020608Orig1s038ltr.pdf
04/05/2017	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018956Orig1s099,020608s036s037ltr.pdf
04/05/2017	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s036lbl.pdf
12/21/2016	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020608s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020608Orig1s034ltr.pdf
07/06/2015	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018956Orig1s095,020608Orig1s031ltr.pdf
10/01/2007	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020608s018ltr.pdf
02/13/2004	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr010ltr.pdf
03/05/2004	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr009ltr.pdf
11/20/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/05/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/19/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/04/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/10/1998	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020608

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/08/2024	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956Orig1s119,020608Orig1s047lbl.pdf
10/08/2024	SUPPL-47	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956Orig1s119,020608Orig1s047lbl.pdf
04/25/2023	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116,020608s049lbl.pdf
02/18/2022	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf
11/09/2017	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf
11/09/2017	SUPPL-38	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf
04/05/2017	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s037lbl.pdf
04/05/2017	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s036lbl.pdf
12/21/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020608s034lbl.pdf
07/06/2015	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf

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