NDA 20120, held by Lupin Atlantis. Triamcinolone Acetonide.
As of Nov 14, 2026, NDA 20120 (Allernaze), held by Lupin Atlantis, was first approved by FDA on Feb 4, 2000, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Allernaze0.05MG/SPRAY · spray, metered;nasal | Triamcinolone Acetonide | Discontinued |
| Jan 7, 2009 | Supplement 2Manufacturing | Approved | |
| Mar 27, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 4, 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
