Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020220
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRAVIST 150 IOPROMIDE 31.2% INJECTABLE;INJECTION Discontinued None Yes No
ULTRAVIST 240 IOPROMIDE 49.9% INJECTABLE;INJECTION Prescription None Yes Yes
ULTRAVIST 300 IOPROMIDE 62.3% INJECTABLE;INJECTION Prescription None Yes Yes
ULTRAVIST 300 IN PLASTIC CONTAINER IOPROMIDE 62.3% INJECTABLE;INJECTION Discontinued None Yes No
ULTRAVIST 370 IOPROMIDE 76.9% 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
05/10/1995 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
04/02/2018 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020220s045ltr.pdf
07/27/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s043ltr.pdf
04/05/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220Orig1s042,021425Orig1s026ltr.pdf
07/06/2015 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf
07/29/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/02/2012 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020220s036ltr.pdf
11/13/2009 SUPPL-35 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf
12/30/2009 SUPPL-33 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s033,021425s017ltr.pdf
08/31/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020220s027ltr.pdf
08/12/2005 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020220s022ltr.pdf
03/12/2004 SUPPL-18 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20220scp018ltr.pdf
10/30/2002 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/11/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/05/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/04/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/27/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/2003 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20220slr008ltr.pdf
12/27/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/25/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1997 SUPPL-2 Efficacy-New Patient Population

Label is not available on this site.

05/30/1995 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
04/02/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s045lbl.pdf
07/27/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s043lbl.pdf
04/05/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s042lbl.pdf
04/05/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220Orig1s042,021425Orig1s026ltr.pdf
07/06/2015 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf
05/02/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf
12/30/2009 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf
08/31/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf
03/12/2004 SUPPL-18 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf

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