NDA 21200, held by Alfasigma. Tegaserod Maleate.
As of Nov 14, 2026, NDA 21200 (Zelnorm), held by Alfasigma, was first approved by FDA on Jul 24, 2002, with 9 approved supplements and 0 published complete response letters.
| Mar 29, 2019 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Aug 21, 2004 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2002 | Original applicationNew molecular entity · Priority review | Approved |
| ZelnormEQ 2MG BASE · tablet;oral | Tegaserod Maleate | DiscontinuedReference drug |
| ZelnormEQ 6MG BASE · tablet;oral | Tegaserod Maleate | DiscontinuedReference drug |
| Mar 29, 2019 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Jun 2, 2006 | Supplement 12Manufacturing | Approved | |
| May 25, 2005 | Supplement 10Manufacturing · Priority review | Approved | |
| Aug 21, 2004 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2004 | Supplement 6Manufacturing · Priority review | Approved | |
| Apr 21, 2004 | Supplement 8Manufacturing · Priority review | Approved | |
| Apr 21, 2004 | Supplement 7Manufacturing · Priority review | Approved | |
| Apr 15, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Jul 24, 2002 | Original applicationNew molecular entity · Priority 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
