Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOVUE-128 | IOPAMIDOL | 26% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ISOVUE-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | AP2 | Yes | Yes |
| ISOVUE-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ISOVUE-370 | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ISOVUE-M 200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | AP1 | Yes | Yes |
| ISOVUE-M 300 | IOPAMIDOL | 61% | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1985 | 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 |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018735s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018735Orig1s070;020327Orig1s025ltr.pdf | |
| 02/18/2022 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018735s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018735Orig1s067; 020327Orig1s023ltr.pdf | |
| 04/05/2017 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018735s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018735Orig1s057,020327Orig1s012ltr.pdf | |
| 07/06/2015 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf | |
| 05/14/2015 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2012 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018735Orig1s054ltr.pdf | |
| 03/10/2006 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/2005 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/2005 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/2003 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/2000 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1999 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1999 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/2002 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf |
| 07/08/2002 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr043ltr.pdf |
| 05/14/1997 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1995 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/15/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/15/1995 | SUPPL-36 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 03/21/1994 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1993 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-33 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 12/21/1992 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/06/1992 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 07/29/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/21/1990 | SUPPL-23 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 01/03/1991 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-21 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 11/27/1990 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/24/1989 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1988 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1989 | SUPPL-12 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-10 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 07/02/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1987 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/24/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1986 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/26/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1986 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/10/1986 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/05/1986 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018735s070lbl.pdf | |
| 02/18/2022 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018735s067lbl.pdf | |
| 04/05/2017 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018735s057lbl.pdf | |
| 07/06/2015 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf | |
| 08/01/2012 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf |
ISOVUE-128
There are no Therapeutic Equivalents.
ISOVUE-200
INJECTABLE;INJECTION; 41%
TE Code = AP2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | No | AP2 | 217134 | HAINAN POLY |
| ISOVUE-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | Yes | AP2 | 018735 | BRACCO |
ISOVUE-250
INJECTABLE;INJECTION; 51%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
| ISOVUE-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
ISOVUE-300
INJECTABLE;INJECTION; 61%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 215382 | HAINAN POLY |
| IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
| ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
| ISOVUE-M 300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
ISOVUE-370
INJECTABLE;INJECTION; 76%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
| ISOVUE-370 | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
ISOVUE-M 200
INJECTABLE;INJECTION; 41%
TE Code = AP1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | No | AP1 | 215382 | HAINAN POLY |
| ISOVUE-M 200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | Yes | AP1 | 018735 | BRACCO |
ISOVUE-M 300
INJECTABLE;INJECTION; 61%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 215382 | HAINAN POLY |
| IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
| ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
| ISOVUE-M 300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |