Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020131
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROHANCE | GADOTERIDOL | 279.3MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|
| 03/05/2025 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020131s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020131Orig1s044;021489Orig1s025ltr.pdf | |
| 07/23/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s043,021489s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s043;021489Orig1s024ltr.pdf | |
| 08/14/2024 | SUPPL-42 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s042, 021489Orig1s023ltr.pdf | |
| 01/26/2024 | SUPPL-40 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s040; 021489Orig1s021ltr.pdf | |
| 11/28/2022 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020131Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020131Orig1s037ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/05/2025 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020131s044lbl.pdf | |
| 08/14/2024 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf | |
| 07/23/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s043,021489s024lbl.pdf | |
| 01/26/2024 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf | |
| 01/26/2024 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf | |
| 11/28/2022 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020131Orig1s037lbl.pdf | |
| 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 |
PROHANCE
INJECTABLE;INJECTION; 279.3MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GADOTERIDOL | GADOTERIDOL | 279.3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218749 | HAINAN POLY |
| PROHANCE | GADOTERIDOL | 279.3MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020131 | BRACCO |