NDA 21025, held by Novartis. Rivastigmine Tartrate.
As of Nov 14, 2026, NDA 21025 (Exelon), held by Novartis, was first approved by FDA on Apr 21, 2000, with 14 approved supplements and 0 published complete response letters.
| Jun 27, 2006 | Supplement 8Efficacy (new indication or use) | Approved | |
| Apr 21, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ExelonEQ 2MG BASE/ML · solution;oral | Rivastigmine Tartrate | DiscontinuedReference drug |
| Dec 18, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Nov 2, 2016 | Supplement 23Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 22Labeling · Standard review | Approved | |
| Oct 1, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Oct 1, 2013 | Supplement 19Labeling · Standard review | Approved | |
| Oct 1, 2013 | Supplement 18Labeling · Standard review | Approved | |
| Jun 27, 2006 | Supplement 8Efficacy (new indication or use) | Approved | |
| Sep 21, 2004 | Supplement 7Labeling · Standard review | Approved | |
| May 5, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Jan 28, 2002 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 25, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 5, 2001 | Supplement 3Labeling · Standard review | Approved | |
| Jul 11, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 21, 2000 | Original applicationNew dosage form · 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
