Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020131
Company: BRACCO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROHANCE GADOTERIDOL 279.3MG/ML 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
11/16/1992 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
12/19/2020 SUPPL-35 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020131s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020131Orig1s035ltr.pdf
04/26/2018 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020131Orig1s028,021489Orig1s006Ltr.pdf
09/15/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020131s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020131Orig1s027ltr.pdf
08/13/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf
12/20/2010 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020131s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf
09/04/2007 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf
06/03/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
07/19/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
03/09/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
01/24/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
09/30/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf
04/02/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
06/13/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
06/13/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
01/29/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
04/08/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
02/01/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
09/30/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf
10/08/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
05/08/1995 SUPPL-5 Labeling

Label is not available on this site.
10/26/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
11/21/1994 SUPPL-2 Efficacy-New Indication

Label is not available on this site.
11/21/1994 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/19/2020 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020131s035lbl.pdf
04/26/2018 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf
04/26/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf
09/15/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020131s027lbl.pdf
08/13/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf
12/20/2010 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020131s024lbl.pdf
09/04/2007 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf

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