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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020923
Company: LIEBEL-FLARSHEIM

Products on NDA 020923

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPTIRAY 240	IOVERSOL	51%	INJECTABLE;INJECTION	Discontinued	None	No	No
OPTIRAY 300	IOVERSOL	64%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
OPTIRAY 320	IOVERSOL	68%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
OPTIRAY 350	IOVERSOL	74%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020923

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20923lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20923ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20923_Optiray.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019710Orig1s067;020923Orig1s030ltr.pdf
02/18/2022	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019710Orig1s065; 020923Orig1s028ltr.pdf
11/18/2020	SUPPL-26	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020923Orig1s026ltr.pdf
11/18/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020923Orig1s025ltr.pdf
12/12/2017	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020923Orig1s021ltr.pdf
04/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf
04/26/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s054,020923Orig1s019ltr.pdf
07/06/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf
12/19/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/12/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf
08/08/2009	SUPPL-5	Labeling		Label is not available on this site.
09/12/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/14/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/13/1999	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020923

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf
02/18/2022	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf
11/18/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf
11/18/2020	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s026lbl.pdf
11/18/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020923s025lbl.pdf
12/12/2017	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s021lbl.pdf
04/26/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf
04/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020923s020lbl.pdf
08/12/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf
07/06/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf
05/29/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20923lbl.pdf

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