Relieves an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NDA 21134, held by Viatris. Nitroglycerin.
As of Nov 15, 2026, NDA 21134 (Nitrostat), held by Viatris, was first approved by FDA on May 1, 2000, with 6 approved supplements and 0 published complete response letters.
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin sublingual tablets are a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Nitrostat0.3MG · tablet;sublingual | Nitroglycerin | RxReference drug |
| Nitrostat0.4MG · tablet;sublingual | Nitroglycerin | RxReference drug |
| Nitrostat0.6MG · tablet;sublingual | Nitroglycerin | RxReference drug |
| Jan 24, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Jan 31, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Aug 29, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Mar 7, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Jul 21, 2011 | Supplement 5Labeling | Approved | |
| Jul 12, 2010 | Supplement 4Labeling | Approved | |
| May 1, 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
