Drugs@FDA: FDA-Approved Drugs
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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