Drugs@FDA: FDA Approved Drug Products

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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 Prescription None Yes Yes
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
12/30/1988 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/05/2017 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf
04/26/2017 SUPPL-54 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
05/13/2016 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/06/2015 SUPPL-52 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
12/06/2013 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/19/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/12/2016 SUPPL-39 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-35 Labeling

Label is not available on this site.

04/25/2008 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s034ltr.pdf
08/28/2007 SUPPL-33 Labeling-Container/Carton Labels

Label is not available on this site.

04/25/2008 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s032ltr.pdf
03/15/2006 SUPPL-30 Labeling-Container/Carton Labels

Label is not available on this site.

08/02/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/23/2001 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1999 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/16/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/25/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/23/1997 SUPPL-21 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019710a_so21_052397.pdf
01/13/1995 SUPPL-19 Labeling

Label is not available on this site.

06/21/1995 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

07/27/1993 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

03/09/1993 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

07/12/1996 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1992 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

10/26/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/22/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1992 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1992 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

01/22/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1992 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

03/30/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1989 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1989 SUPPL-1 Labeling

Label is not available on this site.

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