Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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