NDA 21001, held by Janssen Pharms. Almotriptan Malate.
As of Nov 13, 2026, NDA 21001 (Axert), held by Janssen Pharms, was first approved by FDA on May 7, 2001, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2009 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| May 7, 2001 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AxertEQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Almotriptan Malate | DiscontinuedReference drug |
| AxertEQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Almotriptan Malate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2017 | Supplement 15Labeling · Standard review | Approved | |
| Aug 7, 2014 | Supplement 14Labeling · Standard review | Approved | |
| Apr 30, 2009 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2009 | Supplement 10Labeling · Standard review | Approved | |
| Mar 27, 2009 | Supplement 9Labeling · Standard review | Approved | |
| Mar 27, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Jan 13, 2009 | Supplement 18 | Approved | |
| Jun 1, 2004 | Supplement 2Labeling · Standard review | Approved | |
| May 7, 2001 | 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
