NDA 21231, held by Astrazeneca. Zolmitriptan.
As of Nov 15, 2026, NDA 21231 (Zomig-Zmt), held by Astrazeneca, was first approved by FDA on Feb 13, 2001, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Zomig-Zmt2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Zolmitriptan | DiscontinuedReference drug |
| Zomig-Zmt5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Zolmitriptan | DiscontinuedReference drug |
| Dec 21, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Sep 14, 2012 | Supplement 10Labeling · Standard review | Approved | |
| Sep 14, 2012 | Supplement 11Labeling | Approved | |
| Aug 11, 2010 | Supplement 9Labeling · Standard review | Approved | |
| Jan 8, 2004 | Supplement 5Labeling · Standard review | Approved | |
| May 21, 2003 | Supplement 4Labeling · Standard review | Approved | |
| Oct 9, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Dec 4, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 17, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 13, 2001 | 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
