NDA 20623, held by Validus Pharms. Dolasetron Mesylate.
As of Nov 14, 2026, NDA 20623 (Anzemet), held by Validus Pharms, was first approved by FDA on Sep 11, 1997, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Anzemet50MG · tablet;oral | Dolasetron Mesylate | DiscontinuedReference drug |
| Anzemet100MG · tablet;oral | Dolasetron Mesylate | DiscontinuedReference drug |
| Sep 18, 2014 | Supplement 12Labeling | Approved | |
| Sep 16, 2013 | Supplement 10Labeling · Standard review | Approved | |
| Aug 6, 2013 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2011 | Supplement 9Labeling · Standard review | Approved | |
| Oct 6, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Sep 24, 2007 | Supplement 7Labeling · Standard review | Approved | |
| May 30, 2007 | Supplement 6Labeling · Standard review | Approved | |
| Jun 1, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Mar 16, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1999 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 17, 1997 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 11, 1997 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
