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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019710
Company: LIEBEL-FLARSHEIM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPTIRAY 160 IOVERSOL 34% INJECTABLE;INJECTION Discontinued None No No
OPTIRAY 240 IOVERSOL 51% INJECTABLE;INJECTION Discontinued None Yes 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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/04/2022 SUPPL-64 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710Orig1s064lbl.pdf
05/04/2022 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710Orig1s064lbl.pdf
02/18/2022 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf
01/23/2020 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019710s058lbl.pdf
04/26/2017 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf
04/05/2017 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s055lbl.pdf
08/12/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf
07/06/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf
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