Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018735
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 None Yes Yes
ISOVUE-250 IOPAMIDOL 51% INJECTABLE;INJECTION Prescription None 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 None Yes Yes
ISOVUE-M 300 IOPAMIDOL 61% 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
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
04/05/2017 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
04/05/2017 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

There are no Therapeutic Equivalents.

ISOVUE-250

There are no Therapeutic Equivalents.

ISOVUE-300

INJECTABLE;INJECTION; 61%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOVUE-300 IOPAMIDOL 61% INJECTABLE;INJECTION Prescription Yes AP 018735 BRACCO
SCANLUX-300 IOPAMIDOL 61% INJECTABLE;INJECTION Prescription No AP 090394 SANOCHEMIA CORP USA

ISOVUE-370

INJECTABLE;INJECTION; 76%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOVUE-370 IOPAMIDOL 76% INJECTABLE;INJECTION Prescription Yes AP 018735 BRACCO
SCANLUX-370 IOPAMIDOL 76% INJECTABLE;INJECTION Prescription No AP 090394 SANOCHEMIA CORP USA

ISOVUE-M 200

There are no Therapeutic Equivalents.

ISOVUE-M 300

There are no Therapeutic Equivalents.

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