NDA 21498, held by Romark. Nitazoxanide.
As of Nov 14, 2026, NDA 21498 (Alinia), held by Romark, was first approved by FDA on Nov 22, 2002, with 7 approved supplements and 0 published complete response letters.
| Jun 16, 2005 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2004 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Nov 22, 2002 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alinia100MG/5ML · for suspension;oral | Nitazoxanide | DiscontinuedReference drug |
| Jan 19, 2022 | Supplement 19Labeling · Standard review | Approved | |
| Jul 11, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Sep 29, 2014 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jul 25, 2014 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 16, 2005 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2004 | Supplement 1 | Approved | |
| Jul 21, 2004 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Nov 22, 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
