ANDA 207141, held by Vero Biotech Inc. Nitric Oxide.
As of Nov 14, 2026, ANDA 207141 (Noxivent), held by Vero Biotech Inc, was first approved by FDA on Oct 2, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Noxivent is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2018 | Original application | Approved |
| Noxivent100PPM · gas;inhalation | Nitric Oxide | Discontinued |
| Noxivent800PPM · gas;inhalation | Nitric Oxide | Rx |
| Jul 28, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 2, 2018 | Original application | 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
