NDA 19596, held by Bayer Hlthcare. Gadopentetate Dimeglumine.
As of Nov 13, 2026, NDA 19596 (Magnevist), held by Bayer Hlthcare, was first approved by FDA on Jun 2, 1988, with 39 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 1996 | Supplement 9Efficacy (new indication or use) | Approved | |
| Aug 17, 1993 | Supplement 8Efficacy (new indication or use) | Approved | |
| Aug 10, 1989 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Apr 28, 1989 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Jun 2, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Magnevist469.01MG/ML · injectable;injection | Gadopentetate Dimeglumine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2018 | Supplement 65Labeling · Standard review | Approved | |
| Jul 25, 2018 | Supplement 64Labeling · Standard review | Approved | |
| Apr 26, 2018 | Supplement 63Labeling · Standard review | Approved | |
| Dec 22, 2016 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Nov 2, 2016 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2015 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Jun 11, 2014 | Supplement 57Labeling · Standard review | Approved | |
| Oct 17, 2013 | Supplement 56Labeling · Standard review | Approved | |
| Sep 6, 2013 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Nov 30, 2012 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Mar 29, 2012 | Supplement 51Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 49Labeling | Approved | |
| Aug 19, 2010 | Supplement 34Labeling · Standard review | Approved | |
| May 22, 2009 | Supplement 45Manufacturing | Approved | |
| Sep 4, 2007 | Supplement 43Labeling · Standard review | Approved | |
| Sep 13, 2006 | Supplement 39Labeling · Standard review | Approved | |
| Jan 21, 2005 | Supplement 33Labeling · Standard review | Approved | |
| Oct 29, 2002 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Nov 5, 2001 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Apr 18, 2001 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Nov 14, 2000 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Oct 24, 2000 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Mar 10, 2000 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 10, 1999 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1999 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Oct 26, 1998 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Sep 25, 1997 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1996 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1996 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1996 | Supplement 9Efficacy (new indication or use) | Approved | |
| Nov 16, 1995 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Mar 3, 1995 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1993 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 12, 1992 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Aug 22, 1990 | Supplement 7Labeling | Approved | None posted |
| Aug 10, 1989 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Apr 28, 1989 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1989 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 2, 1989 | Supplement 4Labeling | Approved | None posted |
| Jun 2, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
