Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021425
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRAVIST (PHARMACY BULK) IOPROMIDE 62.3% INJECTABLE;INJECTION Prescription None Yes Yes
ULTRAVIST (PHARMACY BULK) IOPROMIDE 76.9% INJECTABLE;INJECTION Prescription None Yes Yes
ULTRAVIST (PHARMACY BULK) IOPROMIDE 49.9% 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
09/20/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21425ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/04/2018 SUPPL-29 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425Orig1s029ltr.pdf
04/02/2018 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021425s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425s028ltr.pdf
04/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021425s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s042,021425Orig1s026ltr.pdf
11/17/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/06/2015 SUPPL-24 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
05/02/2012 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf
11/13/2009 SUPPL-19 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf
06/23/2010 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021425s017ltr.pdf
08/31/2007 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021425s012ltr.pdf
03/12/2004 SUPPL-6 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21425scp006ltr.pdf
01/23/2003 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21425slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/02/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021425s028lbl.pdf
04/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021425s026lbl.pdf
07/06/2015 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf
05/02/2012 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf
06/23/2010 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf
08/31/2007 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf
03/12/2004 SUPPL-6 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf
09/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf

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