NDA 21780, held by Evus. Nitroglycerin.
As of Nov 14, 2026, NDA 21780 (Nitromist), held by Evus, was first approved by FDA on Nov 2, 2006, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitromist0.4MG/SPRAY · aerosol, metered;sublingual | Nitroglycerin | RxReference drug |
| Jun 24, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Jun 10, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Mar 8, 2011 | Supplement 3Labeling | Approved | |
| Nov 2, 2006 | 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